Registration Dossier

Skin Irritation

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.

Eye Irritation

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.

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

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:

other: 2. rabbits; 3. guinea pigs

Strain:

other: 2. New Zealand White

Details on test animals or test system and environmental conditions:

2. Sex: male

Type of coverage:

other: 2. semi-occlusive; 3. occlusive

Preparation of test site:

other: 2. shaved;

Vehicle:

other: 2. undiluted; 3. distilled water

Controls:

not specified

Amount / concentration applied:

2. 500 mg
3. 95%

Duration of treatment / exposure:

2. 4 hours
3. 24 hours

Observation period:

2.one hour, one, two and three days after removal of the chemical
3. 3 weeks

Number of animals:

2. 6 male rabbits
3. 10 guinea pigs

Details on study design:

2,3. no details available

Irritation parameter:

overall irritation score

Remarks:

Study 2

Basis:

mean

Time point:

other: 1 hour

Reversibility:

fully reversible within: 1 day

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Remarks:

Study 3

Basis:

mean

Time point:

other: 3 weeks

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

2. Some slight irritation was observed one hour after removal of the substance, but all signs had disappeared by the one day observation
3. The chemical did not cause skin irritation in guinea pigs.

Interpretation of results:

other: not irritating

Conclusions:

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.

Executive summary:

Various studies have been reviewed to evaluate the dermal irritation potential of the test chemical. The results are as mentioned below:

A dermal irritation study was performed to assess the dermal irritation potential of the test chemical in rabbits. Approximately 500 mg of the test chemical was applied to the shaved backs of 6 male New Zealand White rabbits and covered with a semi-occlusive dressing for four hours. The animals were examined one hour, one, two and three days after removal of the chemical. Some slight irritation was observed one hour after removal of the test chemical, but all signs had disappeared by the one day observation. Hence, the test chemical can be considered to be not irritating to skin.

This result is supported by another skin irritation study was conducted on guinea pigs to determine the skin irritating effects of the test chemical.The test substance (moistened with distilled water) was applied for 24 h, under occlusive patch, to the skin at a concentration of 95% over a period of 3 weeks.Since the chemical did not induce any skin lesions, the test chemical was considered to be not irritating to the skin of treated guinea pigs.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.

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 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

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

A modified Draize ocular irritation test was conducted to evaluate the irritancy of test chemical to the rabbit eye.

GLP compliance:

no

Species:

rabbit

Strain:

other: 2. not specified 3.New Zealand White

Details on test animals or tissues and environmental conditions:

No data

Vehicle:

other: 2. Not specified 3. unchanged (no vehicle)

Controls:

yes, concurrent no treatment

not specified

Amount / concentration applied:

2) 1, 5, and 10%
3) 100% (0.1ml)

Duration of treatment / exposure:

2) 24 hours
3) Single application

Observation period (in vivo):

2) Eyes were scored at 1, 2, and 24 h and daily thereafter until all irritation had disappeared.
3) 7 days

Number of animals or in vitro replicates:

2) 3 rabbits
3) 6 male rabbits

Details on study design:

2. No data
3. REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not rinsed

Irritation parameter:

overall irritation score

Remarks:

2.

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

110

Remarks on result:

other: No ocular irritation was observed in treated rabbits.

Irritation parameter:

overall irritation score

Remarks:

3.

Basis:

mean

Time point:

7 d

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No data

Other effects:

2. No data
3. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at 1 h post instillation. At day 4, chemosis and discharge were fully reversible in all animals. The test substance did not induce substantial corneal opacity or iritis. The study was terminated before all ocular reactions were completely reversed.

Interpretation of results:

other: Not irritating

Conclusions:

The test material was considered to be not irritating to the eyes of treated rabbits.

Executive summary:

Various studies have been reviewed to evaluate the ocular irritation potential of the test chemical. The results are mentioned below:

A modified Draize ocular irritation test was conducted to evaluate the irritancy of test chemical to the three rabbit eye.The chemical was instilled into the eyes of each rabbit at a dose of 1, 5, and 10% and eyes were scored at 1, 2, and 24 h and daily thereafter until all irritation had disappeared.The test chemical had an ocular irritation index of 0 at all concentrations (at 24 h) Therefore, the test chemical was considered to be not irritating to the rabbits’ eyes.

An ocular irritation study of test chemical was conducted on 6 male New Zealand white rabbits to assess its adverse effects on treated rabbits. The undiluted (0.1 ml) test substance was instilled into the eyes of each rabbit. The eyes were not rinsed and untreated eyes served as controls. Instillation of the test substance was followed by a 7-day observation period. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at 1 h post instillation. At day 4, chemosis and discharge were fully reversible in all animals. The test substance did not induce substantial corneal opacity or iritis. The study was terminated before all ocular reactions were completely reversed. However, the authors noted observations relating to the healing process indicated that the complete reversibility of ocular reactions was likely.Therefore the test chemical was considered to be not irritating to the eyes of treated New Zealand white rabbits.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical cannot be classified as per CLP Regulation.

Endpoint conclusion:

adverse effect observed (irritating)

Endpoint conclusion:

no study available

Skin irritation

Various studies have been reviewed to evaluate the dermal irritation potential of the test chemical. The results are as mentioned below:

A dermal irritation study was performed to assess the dermal irritation potential of the test chemical in rabbits. Approximately 500 mg of the test chemical was applied to the shaved backs of 6 male New Zealand White rabbits and covered with a semi-occlusive dressing for four hours. The animals were examined one hour, one, two and three days after removal of the chemical. Some slight irritation was observed one hour after removal of the test chemical, but all signs had disappeared by the one day observation. Hence, the test chemical can be considered to be not irritating to skin.

This result is supported by another skin irritation study was conducted on guinea pigs to determine the skin irritating effects of the test chemical.The test substance (moistened with distilled water) was applied for 24 h, under occlusive patch, to the skin at a concentration of 95% over a period of 3 weeks.Since the chemical did not induce any skin lesions, the test chemical was considered to be not irritating to the skin of treated guinea pigs.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.

Eye Irritation

Various studies have been reviewed to evaluate the ocular irritation potential of the test chemical. The results are mentioned below:

A modified Draize ocular irritation test was conducted to evaluate the irritancy of test chemical to the three rabbit eye.The chemical was instilled into the eyes of each rabbit at a dose of 1, 5, and 10% and eyes were scored at 1, 2, and 24 h and daily thereafter until all irritation had disappeared.The test chemical had an ocular irritation index of 0 at all concentrations (at 24 h) Therefore, the test chemical was considered to be not irritating to the rabbits’ eyes.

An ocular irritation study of test chemical was conducted on 6 male New Zealand white rabbits to assess its adverse effects on treated rabbits. The undiluted (0.1 ml) test substance was instilled into the eyes of each rabbit. The eyes were not rinsed and untreated eyes served as controls. Instillation of the test substance was followed by a 7-day observation period. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at 1 h post instillation. At day 4, chemosis and discharge were fully reversible in all animals. The test substance did not induce substantial corneal opacity or iritis. The study was terminated before all ocular reactions were completely reversed. However, the authors noted observations relating to the healing process indicated that the complete reversibility of ocular reactions was likely.Therefore the test chemical was considered to be not irritating to the eyes of treated New Zealand white rabbits.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical cannot be classified as per CLP Regulation.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin and eye. Hence, it can be classified under the category "Not Classified" as per CLP Regulation.