Registration Dossier

Administrative data

Description of key information

Skin:
The substance caused transient and very slight irritation to the skin in some animals resulting in an average (24 to 72 hour; all animals) for erythema

and edema 0.5 and 0.06 out of a maximal attainable score of 4, respectively. The effects observed were fully reversible within 7 days.


Eye:
No indication for corneal opacity or iritis was seen in any animal (score = 0). No indications for conjunctival irritation were seen in 5 of 6 animals (score = 0).

The treated eye of one animal exhibited conjunctival effects which was reversible within 72 hours (score of 0.67).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, no 48 h scoring, 24 h exposure, occlusive)
Principles of method if other than guideline:
This study complies with the FHSA standards set forth in 16 CFR 1500.42 (Draize Test).
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Sample # 25-84
- Physical state: white liquid
- Batch No.: 108-074
- Substance No.: 25-84
- Storage: room temperature
- pH: 7.2
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace animals
- Weight at study initiation: no data
- Housing: individually in suspended wire mesh cages
- Diet: Purina Rabbit Chow (Diet #53-21); ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled (no value given)
Type of coverage:
occlusive
Preparation of test site:
other: shaved (left side abraded, right side intact)
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site served as control
Amount / concentration applied:
- Amount(s) applied (volume): 0.5 mL/site
Duration of treatment / exposure:
24 h
Observation period:
7 days (scoring was performed 24 and 72 hours and 7 days after treatment)
Number of animals:
6
Details on study design:
TEST SITE
- Preparation: 24 hours prior to application of test substance
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patches were secured with adhesive tape and wrapped with plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Scoring was performed according to the Draize Scoring System. Additional signs were described.
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #1
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Animal#1 died within 7 days.
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #2
Time point:
other: mean over 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #3
Time point:
other: mean over 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #4
Time point:
other: mean over 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #5
Time point:
other: mean over 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal #6
Time point:
other: mean over 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal: #1, #2, #3 and #4
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Animal#1 died within 7 days.
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #5
Time point:
other: mean over 24 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal #6
Time point:
other: mean over 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h

Table 1: Results from abraded skin

 

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

 

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

24 hours

0

0

1

0

2

0

2

0

2

1

2

1

72 hours

0

0

1

0

1

0

2

0

1

1

2

0

7 day

dead

dead

0

0

0

0

0

0

0

0

1

0

Er = Erythema

Ed = Edema

Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed according to proposed guideline
Remarks:
Incomplete characteriszation of the test substance e.g. no details on test material purity
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the US EPA § 163.81-5 'Primary dermal irritation study' (1978-08-22)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 24 h exposure duration)
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10048
- Physical appearance: yellow powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, 7964 Kisslegg/Allgaeu, Germany; Madoerin AG, 4414 Fuellinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: NAFAG No. 814 (Gossau AG); ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Type of coverage:
occlusive
Preparation of test site:
other: shaved (one side abraded, other side intact)
Vehicle:
other: propylene glycol : saline (70 : 30)
Controls:
other: untreated site served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 50% w/w

Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches covered with an impermeable material and fastened to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
#1, #2, #3, #4, #5, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Other effects:
Scores for abraded skin were not taken into account for evaluation.

Table 1: Results from abraded skin.

 

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

 

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

24 hours

1

0

1

0

1

0

2

1

1

0

1

0

48 hours

0

0

0

0

0

0

1

0

0

0

0

0

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

7 day

0

0

0

0

0

0

0

0

0

0

0

0

Er = Erythema

Ed = Edema

Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Male Hartley guinea pigs were used. Each animal's shaved and depilated, dorsal surface was divided into 4 areas. Each of the 2 areas was dosed with undiluted the test article at 0.1 mL per application site. The 2 remaining areas were not dosed. After approximately 20 minutes, 2 sites on each animal (1 with test article and 1 without) were then exposed to a UV-A dosage of approximately 10.2 joules/cm². The sites were graded for erythema and edema at 24, 48, 72 and 96 hours after exposure.
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (ascited in study report): Tinogard AS
- Batch No.: 2210059J
Species:
guinea pig
Strain:
Hartley
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: suitably licensed dealer; animals were carefully checked upon receipt and prior to test initiation for respiratory or intestinal disease, skin
eruptions, mucosa membrane irritation, postural difficulties, and general condition.
- Age at study initiation: 4 - 6 weeks
- Sex: male
- Weight at study initiation: 368 - 428 g
- Housing: housed in stainless steel cages
- Diet: Lab Diet Certified Guinea Pig Diet #5026; ad libitum
- Water: ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 29.5
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 100%
Duration of treatment / exposure:
Single application
Observation period:
4 days
- grading at 24, 48, 72 and 96 hours after treatment.
Number of animals:
10 (test group), 5 (positive control group)
Details on study design:
The dorsal surface of the animals was shaved and depilated and divided in 4 areas (*site 1-4). 0.1 mL of the test substance or positive control article was uniformly applied to the skin on 2 sites. Each article was spread over an area of approximately 20 cm². Therefore the coverage was approximately 0.005 mL/cm². The skin on the remaining 2 sites was not treated. After approximately 20 minutes, 2 sites on each animal (1 with article and one 1 without) were then exposed to a UV-A dosage of approximately 10.2 joules/cm². After the exposure period, the animals were returned to their cages. All sites* were graded for erythema and edema after treatment. Terminal body weights were also recorded after the 96 hour reading.

- *Site 1 = Treated (0.1 mL test article) and irradiated (10.2 joules/cm² UV-A)
- Site 2 - Untreated and irradiated (10.2 joules/cm² UV-A)
- Site 3 = Treated (0.1 mL test article) and non-irradiated
- Site 4 = Untreated and non-irradiated

DURATION OF IRRADIATION: no data

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 10 animals
Time point:
other: mean over 24, 48, 72 and 96 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Site: treated + irradiation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 10 animals
Time point:
other: mean over 24, 48, 72 and 96 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Site: treated + irradiation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 10 animals
Time point:
other: mean over 24, 48, 72 and 96 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Site: treated + no radiation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 10 animals
Time point:
other: mean over 24, 48, 72 and 96 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: site: treated + no radiation
Irritant / corrosive response data:
TEST SUBSTANCE
No. of animals with erythema and/or edema on irradiated and test substance treated site: 0/10 (after 24, 48, 72 or 96 hours)
No. of animals with erythema and/or edema on irradiated and untreated site: 0/10 (after 24, 48, 72 or 96 hours)
No. of animals with erythema and/or edema on non-irradiated and test substance treated site: 0/10 (after 24, 48, 72 or 96 hours)
No. of animals with erythema and/or edema on non-irradiated and untreated site: 0/10 (after 24, 48, 72 or 96 hours)

POSITIVE CONTROL
No. of animals with erythema and/or edema on irradiated and test substance treated site: 4 of 5 (after 24 hours), 4 of 5 (after 48 hours), 4 of 5 (after 72 hours, and 1 of 5 (after 72 hours)
No. of animals with erythema and/or edema on irradiated and untreated site: 0/5 (after 24, 48, 72 or 96 hours)
No. of animals with erythema and/or edema on non-irradiated and test substance treated site: 0/5 (after 24, 48, 72 or 96 hours)
No. of animals with erythema and/or edema on non-irradiated and untreated site: 0/5 (after 24, 48, 72 or 96 hours)

Mean body weights

- Positive controls: 408 g

- Test group: 429 g

Interpretation of results:
GHS criteria not met
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Housing: individually in suspended wire mesh cages
- Diet: Purina Rabbit Chow (Diet #53-21); ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled (no value given)
Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
3 days (scoring was performed 1 hour and 1, 2 and 3 days after treatment)
(observation period was terminated after 3 days because all scores were 0)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Scoring was performed according to the Draize Scoring System.

TOOL USED TO ASSESS SCORE: fluorescein (after 24h reading and on day 3)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: score in animal #1 1 hour after treatment = 1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 1 h after treatment: 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: score 1 hour after treatment = 2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #3, #4 and #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: US FDA, Federal Register 191.12, 17 September 1964
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(Computing of draize scores for the evaluation of conjunctivae effects combines redness, swelling and discharge to give one conjunctivae score, - lacking detailed information on test animals and test material).
Principles of method if other than guideline:
Draize test
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10048
- Physical state: solid
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Information on strain: Albino rabbits
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 40 mg


Duration of treatment / exposure:
single application, eyes are not washed after instillation
Observation period (in vivo):
72 hours
- grading of ocular reactlon is performed 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Scored according to the Draize system

TOOL USED TO ASSESS SCORE: fluorescein (applied after the 24 hour observation)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 5 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: conjunctivae score in this study = redness + chemosis + discharge
Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In a primary dermal irritation study, performed using a method identical to that proposed in 1972 by Proposed Guidelines of the US EPA § 163.81-5 “Primary dermal irritation study”. 0.5 g of 50% of the test substance (no data on purity) in propylene glycol/saline (70:30) solution was applied under occlusive conditions to the intact and abraded skin of 6 New Zealand White rabbits. Treatment was terminated 24 hours following application and the animals were subsequently subjected to observation until skin reactions were fully reversed or otherwise for up to 7 days. Irritation was scored according to the Draize method 24, 48 and 72 hours as well as 4 and 7 days after application.

On non-abraded skin, average (24 h to 72 h) scores for erythema were 0.33 (for each of 5 animals) and 1.33 (one animals) of a maximal attainable score of 4. Average (24 h to 72 h) scores for edema were 0.0 (for each of 5 animals) and 0.33 (one animals) of a maximal attainable score of 4. No signs of skin irritation were evident by day 7 of observation.

Results from the abraded skin are not included in the final appraisal for skin irritation of the test substance because of its gross deviation from today’s acceptable standardized procedures for the appraisal of skin irritation. In this study, the test substance is not a skin irritant (Ciba Geigy Ltd.1979). 

This study is suitable for assessment of dermal irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline. The test conditions were even harsher (occlusive, extended exposure) than that described by the actual OECD guideline 404.

In a photoxicity test, the test substance (no data on substance purity) was applied to the shaved back of 10 Hartley guinea pigs. The application area was divided in four areas. Two areas (20 cm2each) were treated with 0.1 mL of the test substance, while the remaining two areas were not treated. Twenty minutes after the application, two of the four sites (one treated site, one untreated site) were exposed to UV-A light at a dosage of approx. 10 J/cm2. The sites were graded for erythema and edema at 24, 48, 72 and 96 hours after exposure using the Draize scoring method. The positive control (8 – Methoxypsoralen) caused the adequate response: erythema and/ or edema were present in 4 of 5 animals at each observation time point up to and including 72 hours after treatment. The effect(s) was/were reversible in 3 of the 4 affected animals by the end of the observation period. No signs of test substance induced skin irritation were evident at any site within the 4 day observation period (Supporting Ciba Speciality Chemical Corp., 2000).

Eye irritation

The eye irritation potential of the test substance (no data on purity) was determined in a procedure identical to the procedure described in the Federal register 191.2 (September 1964). 40 mg of the undiluted test substance was applied to the conjunctival sac of one eye of each of 6 Albino rabbits. The other eye remained untreated and served as control. Eyes were not irrigated after treatment. Irritation was recorded after 24, 48 and 72 hours. Appraisal of eye irritation was performed according to the method of Draize. Average Draize scores (24, 48 and 72 hours) were calculated per animal for corneal opacity, iritis, conjunctivae (redness + chemosis + discharge). No indication for corneal opacity or iritis was seen in any animal (score = 0). No indications for conjunctival irritation were seen in 5 of 6 animals. The treated eye of one animal exhibited conjunctival effects which was fully reversible within 72 hours (score of 0.67). In this study, the test substance is not an eye irritant (Ciba Geigy Ltd. 1972). 

This study is suitable for assessment of eye irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline 405.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. Studies similar to OECD 405 and OECD 404 are available for eye and skin irritation, respectively. In both studies, the scores were below the threshold for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.