Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation: The test item produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.  No corrosive effects were noted.
Eye irritation: A single application of the test item to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48‑Hour observation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 02 August 2011 and 09 August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Health and Welfare, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.09 to 2.57 kg.
- Fasting period before study: None.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (2930 Teklad Global Certified Rabbit diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 17 to 23°C
- Humidity (%): Set to achieve limits of 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch.
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
MEASUREMENT OF PH:
The pH of the test item was determined prior to commencement of the study and found to be as follows:
Undiluted as supplied: pH approximately 7.7 (immediately)
90% v/v aqueous preparation of the test item: pH 8.8 (immediately)
: pH 8.8 (after 10 minutes)

PROCEDURE:
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.


SCORING SYSTEM:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:

EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema.: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4

Any other skin reactions and clinical signs of toxicity, if present, were also recorded.

An additional observation was made on Day 7 to assess the reversibility of skin reactions.

Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 70793 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days
Remarks on result:
other: Slight desquamation at 7 day observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 70794 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Slight desquamation at 7 day observation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(Animal 70795 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 70793 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 70794 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
(Animal 70795 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects at any observed time point
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in Table 1.

Well-defined erythema and very slight oedema were noted at two treated skin sites with very slight erythema noted at one treated skin site at the 24, 48 and 72 Hour observations.

Slight desquamation was noted at two treated skin sites and the remaining treated skin site appeared normal at the 7 Day observation.
Other effects:
Bodyweight
Individual bodyweights and bodyweight changes are given in Table 2.
All animals showed expected gain in bodyweight during the study.

The individual mean scores for erythema and oedema required for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals were as follows:

Skin Reaction

Reading (Hours)

Individual Scores – Rabbit Number and Sex

70793Male

70794Male

70795Male

Erythema/Eschar Formation

24

2

2

1

48

2

2

1

72

2

2

1

Total

6

6

3

Mean Score

2.0

2.0

1.0

Oedema Formation

24

1

1

0

48

1

1

0

72

1

1

0

Total

3

3

0

Mean Score

1.0

1.0

0.0

Table 1              Individual Skin Reactions

Skin Reaction

Observation Time
(following patch removal)

Individual Scores – Rabbit Number and Sex

Total

70793Male

70794Male

70795Male

Erythema/Eschar Formation

Immediately

0

0

0

(0 )

1 Hour

0

0

0

( 0 )

24 Hours

2

2

1

5

48 Hours

2

2

1

( 5 )

72 Hours

2

2

1

5

7 Days

0D

0D

0

( 0 )

Oedema Formation

Immediately

0

0

0

( 0 )

1 Hour

0

0

0

( 0 )

24 Hours

1

1

0

2

48 Hours

1

1

0

( 2 )

72 Hours

1

1

0

2

7 Days

0

0

0

( 0 )

Sum of 24 and 72-HourReadings(S)      :          14

Primary Irritation Index (S/6)                   :          14/6 = 2.3

Classification                                        :          MODERATE IRRITANT


(   ) = Total values not used for calculation of primary irritation index

D =     Slight desquamation

Table 2              Individual Bodyweights and Bodyweight Changes

Rabbit Number
and Sex

Individual Bodyweight (kg)

Bodyweight Change (kg)

Day 0

Day 7

70793Male

2.09

2.23

0.14

70794Male

2.11

2.23

0.12

70795Male

2.57

2.73

0.16

Interpretation of results:
other: Not classified as an irritant under CLP. Classified as an irritant under DSD.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item produced a maximum individual mean score of 2.0 and therefore did not meet the criteria for classification according to Regulation (EC) No. 1272/2008. The test item was classified as a Mild irritant (Category 3) according to the Globally Harmonised System of Classification and Labelling of Chemicals.
Executive summary:

Introduction. 

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation August 1998

- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002

- Japanese Ministry of Health and Welfare, 1992

Results. 

A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight or well-defined erythema and very slight oedema. Slight desquamation was noted at two treated skin sites and the remaining treated skin site appeared normal at the 7-Day observation.

Conclusion. 

The test item produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item produced a maximum individual mean score of 2.0 and therefore did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). 

The test item was classified as a Mild irritant (Category 3) according to the Globally Harmonised System of Classification and Labelling of Chemicals.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study performed between 12 September 2011 and 23 September 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Health and Welfare, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.48 to 2.82 kg.
- Fasting period before study: None.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (2930 Teklad Global Certified Rabbit diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 17 to 23°C
- Humidity (%): Set to achieve limits of 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml of the test item was placed into the conjunctival sac of the right eye.


Duration of treatment / exposure:
Single application.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
MEASUREMENT OF PH:
The pH of the test item was determined prior to commencement of the study and found to be as follows:
Undileted as supplied: pH approximately 7.7 (immediately)
90% v/v aqueous preparation of the test item: pH approximately 8.8 (immediately)
: pH approximately 8.8 (after 10 minutes)

PROCEDURE:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 ml of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1 (see attached background material; Appendix 1 - Initial Pain Reaction).

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical Draize Scale for Scoring Ocular Irritation (see Appendix 2 - attached background material).

Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Other:
Any clinical signs of toxicity, if present, were also recorded.

Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 70933 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal70989 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(Animal 70990 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 70933 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 70989 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
iris score
Basis:
mean
Remarks:
(Animal 70990 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: No effects observed at any time point
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 70933 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 70989 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(Animal 70990 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 70933 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 1 at 1 hour observation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 70989 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 1 at 1 hour observation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(Animal 70990 - male)
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 1 at 1 hour observation
Irritant / corrosive response data:
Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.

Pale yellow coloured staining of the fur was noted around all treated eyes during the study.

No corneal or iridial effects were noted during the study.

Minimal conjunctival irritation was noted in all treated eyes one and 24 hours after treatment.

All treated eyes appeared normal at the 48-Hour observation.
Other effects:
Bodyweight
Individual bodyweights and bodyweight changes are given in Table 3.
All animals showed expected gain in bodyweight during the study.

Table 1              Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex

70933Male

70989Male

70990Male

IPR= 2

IPR = 2

IPR = 2

Time After Treatment

1
Hour

24
Hours

48
Hours

72
Hours

1
Hour

24
Hours

48
Hours

72
Hours

1
Hour

24
Hours

48
Hours

72
Hours

CORNEA

 

 

 

 

 

 

 

 

 

 

 

 

E = Degree of Opacity

0

0

0

0

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

 

 

 

 

 

 

 

 

 

 

 

 

D

0

0

0

0

0

0

0

0

0

0

0

0

Score (D x 5)

0

0

0

0

0

0

0

0

0

0

0

0

CONJUNCTIVAE

 

 

 

 

 

 

 

 

 

 

 

 

A = Redness

1Sf

1

0

0

1Sf

1

0

0

1Sf

1Sf

0Sf

0

B = Chemosis

1

0

0

0

1

0

0

0

1

0

0

0

C = Discharge

1

0

0

0

1

0

0

0

1

0

0

0

Score (A + B + C) x 2

6

2

0

0

6

2

0

0

6

2

0

0

Total Score

6

2

0

0

6

2

0

0

6

2

0

0


IPR=  Initial pain reaction

Sf =     Pale yellow coloured staining of the fur

Table 2              Individual Total Scores and Group Mean Scores for Ocular Irritation

Rabbit Number

and Sex

Individual Total Scores At:

1 Hour

24 Hours

48 Hours

72 Hours

70933Male

6

2

0

0

70989Male

6

2

0

0

70990Male

6

2

0

0

Group Total

18

6

0

0

Group Mean Score

6.0

2.0

0.0

0.0

Table 3              Individual Bodyweights and Bodyweight Changes

Rabbit Number
and Sex

Individual Bodyweight (kg)

Bodyweight Change (kg)

Day 0

Day 3

70933Male

2.48

2.50

0.02

70989Male

2.67

2.71

0.04

70990Male

2.82

2.87

0.05

Interpretation of results:
not classified
Remarks:
Migrated information minimal irritant Criteria used for interpretation of results: EU
Conclusions:
The test item produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.
Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation August 1998

- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2002

- Japanese Ministry of Health and Welfare, 1992

Result.

A single application of the test item to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48‑Hour observation.

Conclusion.

The test item produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Introduction. 

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. 

Results. 

A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight or well-defined erythema and very slight oedema. Slight desquamation was noted at two treated skin sites and the remaining treated skin site appeared normal at the 7-Day observation.

Conclusion. 

The test item produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item produced a maximum individual mean score of 2.0 and therefore did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). 

Eye Irritation

Introduction.

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. 

Results.

A single application of the test item to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48‑Hour observation.

Conclusion.

The test item produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.


Justification for selection of skin irritation / corrosion endpoint:
The study has been conducted according to OECD Guideline 405 and GLP and is adequately reported. The study has been assigned a reliability of 1.

Justification for selection of eye irritation endpoint:
The study has been conducted according to OECD Guideline 405 and GLP and is adequately reported. The study has been assigned a reliability of 1.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation/corrosion:

Classification according to CLP (Regulation (EC) No 1272/2008):

The results from the skin irritation study were evaluated according to the Classification, Labelling and Packaging Regulation (CLP) criteria.

The mean scores for erythema (based on gradings at 24, 48 and 72 hours) in the three tested animals were: 2, 2 and 1.

The mean scores for oedema (based on gradings at 24, 48 and 72 hours) in the three tested animals were: 1, 1 and 0.

The test item therefore produced a maximum mean score of 2.0 (for erythema).

The substance does not meet the criteria for classification as a Category 2 irritant, according to the CLP criteria, which requires a mean score for erythema/eschar or oedema of ≥2.3 - ≤4.0 in at least two of three tested animals.

 

All erythema and oedema had resolved by the 7 day observation, although slight desquamation was noted in two animals at the 7 day observation. However, this desquamation was not sufficient for classification.

 

The substance is therefore not classified as a skin irritant according to CLP.

 

Classification according to DSD (Directive 67/548/EEC):

The results from the skin irritation study were also evaluated according to Directive 67/548/EEC (DSD) criteria, which states inflammation of the skin is significant if:

In the case where the test has been completed using three animals, either erythema and eschar formation or oedema formation equivalent to a mean value of 2 or more calculated for each animal separately has been observed in two or more animals.

 

Based on this DSD criteria, the substance is classified as irritating to skin as two animals have a mean score for erythema (based on gradings at 24, 48 and 72 hours) of 2.

 

Eye irritation/corrosion:

The results from the eye irritation study were evaluated according to the Classification, Labelling and Packaging Regulation (CLP) criteria and Directive 67/548/EEC (DSD) criteria.

The mean scores of individual animals for corneal opacity, iritis, conjunctival redness and chemosis (based on gradings at 24, 48 and 72 hours) were calculated for each of the three animals tested. There was a maximum mean score of 0.33 for conjunctival redness, obtained for all three animals. The mean scores for corneal opacity, iritis and chemosis were 0 for all animals.

The mean scores for redness of 0.33 were below the threshold values for a positive response (≥2 for redness under CLP and ≥2.5 for redness under DSD) and all effects were fully reversible.

The substance therefore does not meet the criteria for classification as an eye irritant according to either the CLP or DSD criteria.

Categories Display