Registration Dossier

Skin Irritation:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Eye Irritation:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

Weight of evidence approach based on various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on various test chemicals

Principles of method if other than guideline:

Weight of evidence approach based on various test chemicals

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: 1. undiluted; 2. water; 3. water

Controls:

not specified

Amount / concentration applied:

1. 0.5 ml
2. 500 mg of the test chemical was moistened with water at after removal of the patches.
3. 0.5 g of the test chemical moistened with water

Duration of treatment / exposure:

single

Observation period:

1. 24 and 72 hours
2. 1, 24, 48 and 72 hours
3. at 1, 24, 48 and 72 hours

Number of animals:

1. 6
2. 3
3. 3

Details on study design:

The data is based on weight of evidence approach based on various test chemicals

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Executive summary:

The skin irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

The dermal irritation potential of the test chemical was assessed in rabbits.0.5 ml of semi permanent dye containing 0.38% (wt/wt) test chemical was applied to the intact skin of 6 rabbits and observed for signs of irritation. The dermal reactions were observed and scored at 24 and 72 hours. The maximum score for dermal reactions was 4.

No signs of irritation were noted on the rabbit skin. The primary irritation index was reported to be 0.0.

Based on the scores and observations, the test chemical can be considered not irritating to rabbit skin.

This is supported by the results of a study performed on rabbits in accordance with OECD 404 Guidelines to determine the degree of irritation caused by the test chemical. The study was performed One day prior to the application of the test chemical, the dorsal area of the trunk of 3 female New Zealand White rabbits was clipped free of fur. 500 mg of the test chemical was moistened with water was applied clipped skin of 3 rabbits under semi-occlusive conditions for 4 hours. Subsequently, the dressings were removed, any residual test substance was wiped off. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

No signs of irritation were noted on the rabbit skin.Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Based on the observations, the test chemical can be considered not irritating to rabbit skin.

The above studies are supported by the results of a study performed on rabbits in accordance with OECD 404 and 92/69/EEC. Annex V Guidelines to assess the dermal irritation potential of the test chemical was assessed in rabbits. 0.5 g of the test chemical moistened with water was applied to 6.25 cm² area of intact skin of 3 female New Zealand albino rabbits under semi-occlusive conditions for 4 hours. Remaining test substance was removed by swabbing with cotton wool swabs soaked in warm water.The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches. An index of Cutaneous Primary Irritation was calculated from the mean scores at the sites and at each time point. No signs of irritation were noted on the rabbit skin. Red/orange staining was reported at all time points. The primary irritation index was reported to be 0.0.

Based on the scores and observations, test chemical can be considered not irritating to rabbit skin.

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on test chemicals

Justification for type of information:

Weight of evidence approach based on test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Weight of evidence approach based on test chemicals

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. 100 mg
2. undiluted 100mg

Duration of treatment / exposure:

single

Observation period (in vivo):

1. 1, 2, 3, and 7 days
2. no data available

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

1. 6
2. no data available

Details on study design:

The data is based on weight of evidence approach based on various test chemicals

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Executive summary:

The eye irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

The ocular irritation potential of the test chemical was assessed in rabbits. 100 mg of the powdered dye was instilled in one eye of 6 rabbits and the other eye served as control. The treated eyes were observed and scored at 1, 2, 3, and 7 days. The maximum attainable score was 110.

No signs of irritation were observed in the treated eyes of rabbits at any time point.

The scores obtained at 1, 2, 3, and 7 days were 0.0. Hence, the test chemical can be considered to be not irritating to rabbit eyes.

This is supported by the results of an ocular irritation study of the test chemical conducted on rabbits to assess the eye irritancy of test chemical.

Undiluted 100mg of test chemical was installed into the eye of each rabbits which produced Slight conjunctival changes only after one hour.

Since the observed effects were cleared, the test chemical was considered to be not irritating to the rabbits’ eye.

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin Irritation

The skin irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

The dermal irritation potential of the test chemical was assessed in rabbits.0.5 ml of semi permanent dye containing 0.38% (wt/wt) test chemical was applied to the intact skin of 6 rabbits and observed for signs of irritation. The dermal reactions were observed and scored at 24 and 72 hours. The maximum score for dermal reactions was 4.

No signs of irritation were noted on the rabbit skin. The primary irritation index was reported to be 0.0.

Based on the scores and observations, the test chemical can be considered not irritating to rabbit skin.

This is supported by the results of a study performed on rabbits in accordance with OECD 404 Guidelines to determine the degree of irritation caused by the test chemical. The study was performed One day prior to the application of the test chemical, the dorsal area of the trunk of 3 female New Zealand White rabbits was clipped free of fur. 500 mg of the test chemical was moistened with water was applied clipped skin of 3 rabbits under semi-occlusive conditions for 4 hours. Subsequently, the dressings were removed, any residual test substance was wiped off. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

No signs of irritation were noted on the rabbit skin. Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Based on the observations, the test chemical can be considered not irritating to rabbit skin.

The above studies are supported by the results of a study performed on rabbits in accordance with OECD 404 and 92/69/EEC. Annex V Guidelines to assess the dermal irritation potential of the test chemical was assessed in rabbits. 0.5 g of the test chemical moistened with water was applied to 6.25 cm² area of intact skin of 3 female New Zealand albino rabbits under semi-occlusive conditions for 4 hours. Remaining test substance was removed by swabbing with cotton wool swabs soaked in warm water. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches. An index of Cutaneous Primary Irritation was calculated from the mean scores at the sites and at each time point.

No signs of irritation were noted on the rabbit skin. Red/orange staining was reported at all time points. The primary irritation index was reported to be 0.0.

Based on the scores and observations, test chemical can be considered not irritating to rabbit skin.

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Eye Irritation