Benzene, ethenyl-, ar-bromo derivs.

Endpoint summary

Description of key information

Skin:

The test substance was considered to be a moderately irritating substance based on a PII (primary irritation index calculated with 24 and 72 hours values) of 4.1. Fissuring and desquamation were observed in most animals.

Eye:

A weight of evidence approach was taken to fulfil the data requirements for eye irritation; the results of two reliable studies are presented.

Naas (1987) - Clear or purulent discharge was observed in a total of 5 rabbits between 1 to 72 hours. The highest overall irritation score achieved during the study, 7.33, occurred within 24 hours. All effects were found to be fully reversible within 7 days.

Nardini P et al (1983) - Based on maximal primary eye irritation indexes of 11 and 10.67, respectively, for the unrinsed and rinsed group, the test substance was classified as mildly irritating to the eye. Thick white discharge, alopecia in area around eye and eschar formation in area under eye with gradual exfoliation was also observed.

Respiratory:

Although not sufficient for use as a key study under Acute toxicity: inhalation (provided as a supporting study), Biesemeier J. A. (1980) was found to contain observations during the course of the study adequate for classification and labelling purposes concerning respiratory tract irritation. Reactions during exposure included lacrimation, clear nasal discharge, inactivity, and rapid, shallow breathing. All animals appeared normal in the afternoon following exposure and during the 2-day observation period.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 March to 9 April 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocol, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2087 to 2399 g
- Housing: individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow # 5322 ad libitum
- Water: tap water from on-site wells ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 70-73 Fahrenheit degrees
- Humidity: 40-66%
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: from 26 March to 9 April 1987

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6 (3 males and 3 females)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: fissuring present on days 4 and 5 and desquamation observed from day 6 to 14

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 9 days

Remarks on result:

other: fissuring present on days 4 and 5; desquamation observed on days 6 to 13

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: desquamation observed on days 5 to 13

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: desquamation observed from day 5 to 14

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

The test substance was considered to be a moderately irritating substance based on a PII (primary irritation index calculated with 24 and 72 hours values) of 4.1.
According to the EU criteria, the test substance is classified as a skin irritant and labelled with R38

Other effects:

fissuring and desquamation were observed in most animals

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

Irritating to the skin - R38

Executive summary:

In a primary skin irritation study, 0.5 mL of undiluted test substance were applied to the intact shaved skin of 6 rabbits. Significant inflammation of the skin was observed. The test substance was therefore considered to be a skin irritant and should be labelled with R38.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1 to 15 June 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

A total of 6 animals were used, application on intact or abraded skin, 24 hrs exposure.

Principles of method if other than guideline:

A total of 6 rabbits were used. Four test sites were prepared for each animal, located lateral to the midline of the back approximately 10 cm apart. Two of the test sites were further prepared by making criss-cross epidermal abrasions with a 25 gauge hypodermic needle, sufficiently deep to penetrate the stratum corneoum but not deep enough to penetrate the dermis and cause bleeding. Exposure lasted 24 hours.

GLP compliance:

no

Remarks:

Not-GLP but QA statement included in the report

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Clerco Reasearch Farm, Cincinnati, Ohio, USA
- Age at study initiation: young adults
- Weight at study initiation: 2.112 to 2.506 kg
- Housing: individually in steel wire-bottomed cages suspended above cage board that was changed 3 times a week
- Diet: Purina Certified Rabbit Chow 5322 ad libitum
- Water: ad libitum
-Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Animals were maintained in a temperature and humidity controlled room with 12-hour light/dark cycles
IN-LIFE DATES: from 1 to 15 June 1983

Type of coverage:

occlusive

Preparation of test site:

other: shaved or shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL to each test site

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

6 (3 males and 3 females)

Details on study design:

The Primary Dermal Irritation Index was calculated by adding the mean scores for erythema and oedema of the intact and abraded test sites from the 24- and 72-hour grading periods and dividing the value by 2. On this basis a substance was considered as nonirritating if PDII was 0, mildly irritating if PDII was 0.1-1.9, moderately irritating if PDII was 2.0-5.9 and severely irritating if PDII was 6.0-8.0.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 + 72 hours / 2

Score:

6.6

Irritation parameter:

other: primary dermal irritation scores

Basis:

mean

Time point:

other: 24 hours

Score:

7.6

Irritation parameter:

other: primary dermal irritation scores

Basis:

mean

Time point:

other: 72 hours

Score:

5.5

Irritation parameter:

other: primary dermal irritation scores

Basis:

mean

Time point:

other: 96 hours

Score:

5

Irritation parameter:

other: primary dermal irritation scores

Basis:

mean

Time point:

other: 7 days

Score:

0.8

Irritation parameter:

other: primary dermal irritation scores

Basis:

mean

Time point:

other: 14 days

Score:

0

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Severely irritating

Other effects:

Subcutaneaous haemorrhage was observed in 2 animals at 24 hours.
Desquamation (epithelial scales, flakes) was observed in all 6 animals at 96 hours and 7 days.

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Draize J.H. 1965

Conclusions:

Irritant to the skin

Executive summary:

0.5 mL of undiluted test substance were applied to 4 test sites, two of which abraded, of each of the 6 rabbits. Exposure lasted 24 hours. Based on a Primary dermal Irritation Index of 6.6, the test substance was classified as severely irritating to the skin.

Reference 4

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

27 to 29 October 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test method was in agreement with Title 49, Code of Federal Regulation, 173.1200, Appendix A. The test material was applied to the intact skin in the amount of 0.5 mL. The treated area was covered with a 1 x 1 inch gauze patch secured with tape, overwrapped with saran wrap, and secured with elastoplast tape. The rabbits were collared during the 4-hr exposure. At the end of the exposure period the bandages were removed and the treated area was examined for skin irritation and corrosion (according to Draize, 1965). After the initial examination, the application site was wiped with a wet paper towel to prevent further exposure. Examinations were repeated at 24 and 48 hours.

GLP compliance:

no

Remarks:

Not-GLP but QA statement included.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: 3 males and 3 females
- Age at study initiation: approximately 14 weeks
- Housing: individually in screen bottom cages
- Diet and water: commercial laboratory feed and water ad libitum
- Acclimation period: at least 7 days

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

6

Irritation parameter:

other: primary dermal irritation score (PDIS)

Basis:

mean

Time point:

other: 4 hours

Score:

3.1

Irritation parameter:

other: primary dermal irritation score (PDIS)

Basis:

mean

Time point:

other: 24 hours

Score:

3.5

Irritation parameter:

other: primary dermal irritation score (PDIS)

Basis:

mean

Time point:

other: 48 hours

Score:

3.3

Irritant / corrosive response data:

Not corrosive

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: other: Title 49, Code of Federal Regulation, 173.1200, Appendix A (referring to Draize J.H. 1965)

Conclusions:

The test substance was not corrosive when applied to the skin of 6 rabbits for 4 hours.

Executive summary:

For DOT Hazard Classification in accordance with Title 49, Code of Federal Regulations, 173.1200, Appendix A, three male and three female rabbits were each treated dermally with a 0.5 mL aliquot of the undiluted test material. The treated area covered with a gauze patch and saran wrap. Following the 4 -h exposure period the bandages were removed and the treated area examined for skin irritation and corrosion. The application site was wiped after examination in order to prevent further exposure. Examinations were repeated at 24 and 48 -hour.

The primary dermal mean irritation scores (with maximum possible score 8.0) were: 3.1 at the 4-h scoring, 3.5 at the 24-h scoring, and 3.3 at the 48-h scoring. No signs of corrosion were evident for any of the treated animals.

Reference 5

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

11 to 20 November 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

9 animals used.

Principles of method if other than guideline:

9 animals used (6 non rinsed, 3 rinsed).

GLP compliance:

no

Remarks:

Not-GLP but QA statement included.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Clerco Reasearch Farm, Cincinnati, Ohio, USA
- Age at study initiation: young adults
- Weight at study initiation: 1.85 to 3.65 kg
- Housing: individually in steel wire-bottomed cages suspended above cage board that was changed 3 times a week
- Diet: Purina Certified Rabbit Chow 5322 ad libitum
- Water: ad libitum
-Acclimation period: 10 to 32 days
ENVIRONMENTAL CONDITIONS
Animals were maintained in a temperature and humidity controlled room with 12-hour light/dark cycles
IN-LIFE DATES: from 11 to 20 November 1982

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

20-30 seconds for the 3 animals in which eyes were rinsed

Observation period (in vivo):

10 days

Duration of post- treatment incubation (in vitro):

Not applicable

Number of animals or in vitro replicates:

9 (6 non rinsed, 3 rinsed).

Details on study design:

Grading for irritation and injury were made at 24, 48 and 72 hours and 4, 7 and 10 days, using the standard scoring system of Draize. Fluorescein examinations were used to facilitate evaluation of potential corneal damage. The maximum score at any examination is 110 points. Classification is given on the basis of the primary eye irritation index (worst value obtained at each time point).

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

11

Max. score:

110

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: non-rinsed group

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

10.67

Max. score:

110

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #4

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #5

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #6

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #4

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #5

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

iris score

Basis:

animal #6

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 4 Days

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 4 Days

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 4 Days

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: 4 Days

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 4 Days

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 4 Days

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

other: 4 Days

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 4 Days

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

other: 4 Days

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

chemosis score

Remarks:

Redness

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Not rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

iris score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed

Irritation parameter:

iris score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 4 Days

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 4 Days

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 4 Days

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

other: 4 Days

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of moderate irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

other: 4 Days

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 4 Days

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

7 d

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 4 Days

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

10 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Rinsed group

Irritant / corrosive response data:

Mildly irritating

Other effects:

Thick white discharge, alopecia in area around eye and eschar fromation in area under eye with gradual exfoliation were also observed.

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

Mildly irritating

Executive summary:

In a primary eye irritation study, 0.1 mL of the test substance were applied to the right eye of each of 9 rabbits. The left eye remained untreated and served as control. 20 to 30 seconds after instillation the treated eyes of 3 rabbits were rinsed for 1 minute with two 60cc syringes filled with lukewarm distilled water.

Based on maximal primary eye irritation indexes of 11 and 10.67, respectively, for the unrinsed and rinsed group, the test substance was classified as mildly irritating to the eye.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

30 March to 6 April 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2162 to 2400 g
- Housing: individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow # 5322 ad libitum
- Water: tap water from on-site wells ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 70-73 Fahrenheit degrees
- Humidity: 40-66%
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: from 30 March to 6 April 1987

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

treated eyes were not washed after instillation

Observation period (in vivo):

7 days

Duration of post- treatment incubation (in vitro):

Not applicable

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

Not specified

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

other: 96 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 96 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: 96 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 96 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Rednss

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

other: 96 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

other: 1 hour

Score:

2

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 1 hour

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

other: 1 hour

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

other: 1 hour

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

other: 1 hour

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

other: 96 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #1

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #2

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #3

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #4

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #5

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal #6

Time point:

7 d

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Mildly irritating

Other effects:

Clear or purulent discharge was observed in a total of 5 rabbits between 1 to 72 hours

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

The test substance received a descriptive rating classification of mildly irritating. According the EU criteria the substance is classified as Irritant to the eye and should be labelled with R36

Executive summary:

In a primary eye irritation study, 0.1 mL of the tets substance were applied to the right eye of each of 6 rabbits. The left eye remined untreated and served as control. Irritating effects were observed in all animals, limited to the conjunctivae, and fully reversible within 7 days. The test substance received a descriptive rating classification of mildly irritating. According the EU criteria the substance is classified as Irritant to the eye and should be labelled with R36.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin:

The key study for this data requirement, Naas DJ (1987) was conducted in line with EPA OPP 81-5 (Acute Dermal Irritation) and in compliance with GLP. The study was assigned a reliability score of 1. A further two studies were provided in support, Thompson GW (1983) and Thompson GW (1980), which confirmed that the test material was irritating to the skin, but not corrosive. Both studies were assigned reliability scores of 2.

Eye:

A weight of evidence approach was taken to fulfil the data requirements for eye irritation potential. Naas DJ (1987) and Nardini P et al (1983). Naas DJ (1987) was conducted in compliance with GLP and in accordance with the guideline EPA OPP 81-4 (Acute Eye Irritation) and was assigned a reliability score of 1. Nardini P., LeQuire M. and Kingerly A.F. (1983) was not reported to have complied with a specific guideline, however the methodology is comparable OECD 405, the study was not reported to have been performed in compliance with GLP, but is slightly more comprehensive in its design. Nardini P et al (1983) was assigned a reliability score of 2. Both studies confirmed that the substance is irritating to the eyes (reversible effects).

Respiratory:

Biesemeier J.A. (1980), summarised under Acute toxicity: inhalation as a supporting study was used to assess the substance for respiratory tract irritation. The study was not performed in compliance with GLP, or to a standardised guideline, however the study was performed in line with good scientific practices, a reliability score of 2 was assigned in accordance with the criteria outlined in Klimisch (1997). Although the study was not adequate for classification and labelling of the substance concerning acute toxicity via inhalation, the observations performed were sufficient to assess respiratory tract irritation.

Justification for selection of skin irritation / corrosion endpoint:

The key study was selected, as the study was performed in line with a current standardised guideline and in compliance with good laboratory conditions. The supporting studies were performed using methods equivalent to standardised guidelines, both studies pre-dated GLP inception, however a quality assurance statement was included in the reporting. The results of the supporting study confirmed the findings of the key study.

Justification for selection of eye irritation endpoint:

Two good quality studies were available for the assessment of eye irritation potential. The conclusions of the two studies were in agreement, the studies were therefore presented as a weight of evidence, and the conclusions from both studies were considered for classification and labelling and risk assessment purposes.

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: moderately irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin:

According to the criteria in directive 67/548/EEC and regulation (EC) No 1272/2008, the substance meets the criteria for classification as a skin irritant R38 and category 2 irritant H315, respectively.

Eye:

According to the criteria in directive 67/548/EEC and regulation (EC) No 1272/2008, the substance meets the criteria for classification as irritating to eyes R36 and irritating to eyes Category 2 H319, respectively.

Respiratory tract:

The substance meets the criteria for classification as a respiratory tract irritant due to the effects noted in the acute toxicity inhalation study, provided as supporting information. Therefore under regulation EC No. 1207/2006 the substance should be labelled with H 335 Specific organ toxicity after single exposure category 3 (with the signal word warning) May cause respiratory tract irritation. Accordingly under the directive 67/548/EEC, the substance should be labelled as R37 Irritating to respiratory system.