Registration Dossier

Skin irritation:

The test chemical was considered to be irritating to the skin of rabbits after 4 hours exposure period and hence it is likely to claasify as skin irritant "Category 2".

Eye irritation:

The test chemical was considered to be slightly irritating to the eyes of six rabbits and hence it is likely to classify as an eye irritant "Category 2".

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Experimental data from various test chemicals

Justification for type of information:

Data for the target chemical is summarized bases on experimental data from 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: Standard skin irritation protocols

Principles of method if other than guideline:

WoE for the target CAS is summarized based on data from various test chemicals

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No Data Available

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

Intact or abraded skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500 mg (0.5ml)

Duration of treatment / exposure:

4 hours

Observation period:

24/48/72 hours

Number of animals:

6 rabbits

Details on study design:

TEST SITE
- Area of exposure: clipped hair free back of six rabbis
- % coverage: one-inch square/ site

- Type of wrap if used: Each test site was covered with cotton gauze pads and secured with tape in contact with the skin for 24 h. The entire trunk of the animal was wrapped with rubberized cloth or other occlusive impervious material to retard evaporation of the test substance. After the 24-h exposure period, the wrappings were removed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: No data

SCORING SYSTEM: The sites were scored after approximately 1 h for erythema and edema, using a standard Draize scoring system on a scale of 0–4 for each parameter (maximum of 8.0 Primary Irritation Index). Scoring was repeated at 24, 48 and 72 h post-exposure or until all irritation resolved.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Mild skin irritation was present on the treated area after 4 hours exposure period

Other effects:

No data

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test chemical was considered to be irritating to the skin of rabbits after 4 hours exposure period.

Executive summary:

Data available for the various test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:

Primary skin irritation study of the two test chemicals was conducted on the intact or abraded skin of six rabbits to observe its irritation efficacy under occlusive condition. Brieﬂy, the backs of six rabbits were clipped free of hair. Each test material was placed on two one-inch square sites on the same animal. One site was intact and the other site was abraded. Each test site was covered with cotton gauze pads and secured with tape in contact with the skin for 24 h. The entire trunk of the animal was wrapped with rubberized cloth or other occlusive impervious material to retard evaporation of the test substance. After the 24-h exposure period, the wrappings were removed. The sites were scored after approximately 1 h for erythema and edema, using a standard Draize scoring system on a scale of 0–4 for each parameter (maximum of 8.0 Primary Irritation Index). Scoring was repeated at 24, 48 and 72 h post-exposure or until all irritation resolved. Mild skin irritation was observed on treated area after 4 hours exposure period. The test chemicals was considered to be irritating to the skin of rabbits after 4 hours exposure period and hence it is likely to classify as a skin irritant.

Based on the data available and applying the weight of evidence approach, the test chemical was considered to be irritating to the skin of rabbits after 4 hours exposure period.

Endpoint conclusion:

adverse effect observed (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:

Experimental data from various test chemicals

Justification for type of information:

Data for the target chemical is summarized based on the experimental data from 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: Standard eye irritation protocols

Principles of method if other than guideline:

Draize eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not specified

Vehicle:

not specified

Controls:

yes

Amount / concentration applied:

100mg (0.1ml)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24 /48/72 hours

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

TEST SITE
- Area of exposure: conjunctival sac of one eye of six rabbits

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
No data
- Time after start of exposure:
No data

SCORING SYSTEM: Scores were based on the degree or extent of opacity on the cornea, the redness on the iris and the chemosis and discharge on the conjunctiva, using a standard scale at intervals of 1, 24, 48 and 72 h or until all irritation resolves. More emphasis was placed on the opacity of the cornea, which was given a maximum score of 80. Conjunctival changes had a maximum score of 20 and iritis had maximum score of 10. The total maximum score was 110.

TOOL USED TO ASSESS SCORE: No detailed data is available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Slight eye irritation was observed in treated rabbits.

Other effects:

No data

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test material Ammonium phosphinate (CAS No: 7803-65-8) was considered to be irritating to the eyes six of rabbits.

Executive summary:

Data available for the various test chemicals was reviewed to determine the ocular irritation potential of the test chemical Ammonium phosphinate (CAS No: 7803-65-8). The studies are as mentioned below:

Draize eye irritation test was carried out for test chemical to assess the degree of eye irritation caused by the chemical. In this study, 100 mg test material was instilled into the conjunctival sac of one eye each of six rabbits. The other eye served as a control. The eyelid was held shut for a few seconds and released. Washing, when indicated, occurred within 20–30 s of exposure and consisted of ﬂooding the eye with large amounts of water for 1 min. Scores were based on the degree or extent of opacity on the cornea, the redness on the iris and the chemosis and discharge on the conjunctiva, using a standard scale at intervals of 1, 24, 48 and 72 h or until all irritation resolves. More emphasis was placed on the opacity of the cornea, which was given a maximum score of 80. Conjunctival changes had a maximum score of 20 and iritis had maximum score of 10. The total maximum score was 110. The chemical induced slight eye irritation in treated rabbits after 24 hours. Hence the test chemical was considered to be slightly irritating to the eyes of six rabbits and hence it is likely to classify as an eye irritant.

Based on the data available and applying the weight of evidence approach, it can be concluded that the test chemical is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2 (Irritant)”.

Endpoint conclusion:

adverse effect observed (irritating)

Endpoint conclusion:

no study available

Skin irritation:

Data available for the various test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:

Primary skin irritation study of the two test chemicals was conducted on the intact or abraded skin of six rabbits to observe its irritation efficacy under occlusive condition. Brieﬂy, the backs of six rabbits were clipped free of hair. Each test material was placed on two one-inch square sites on the same animal. One site was intact and the other site was abraded. Each test site was covered with cotton gauze pads and secured with tape in contact with the skin for 24 h. The entire trunk of the animal was wrapped with rubberized cloth or other occlusive impervious material to retard evaporation of the test substance. After the 24-h exposure period, the wrappings were removed. The sites were scored after approximately 1 h for erythema and edema, using a standard Draize scoring system on a scale of 0–4 for each parameter (maximum of 8.0 Primary Irritation Index). Scoring was repeated at 24, 48 and 72 h post-exposure or until all irritation resolved. Mild skin irritation was observed on treated area after 4 hours exposure period. The test chemicals was considered to be irritating to the skin of rabbits after 4 hours exposure period and hence it is likely to classify as a skin irritant.

Based on the data available and applying the weight of evidence approach, the test chemical was considered to be irritating to the skin of rabbits after 4 hours exposure period. Comparing the above annotations with the criteria of CLP regulation, it can be classified as “Category 2 (Irritant)”.

Eye irritation:

Data available for the various test chemicals was reviewed to determine the ocular irritation potential of the test chemical Ammonium phosphinate (CAS No: 7803-65-8). The studies are as mentioned below:

Draize eye irritation test was carried out for test chemical to assess the degree of eye irritation caused by the chemical. In this study, 100 mg test material was instilled into the conjunctival sac of one eye each of six rabbits. The other eye served as a control. The eyelid was held shut for a few seconds and released. Washing, when indicated, occurred within 20–30 s of exposure and consisted of ﬂooding the eye with large amounts of water for 1 min. Scores were based on the degree or extent of opacity on the cornea, the redness on the iris and the chemosis and discharge on the conjunctiva, using a standard scale at intervals of 1, 24, 48 and 72 h or until all irritation resolves. More emphasis was placed on the opacity of the cornea, which was given a maximum score of 80. Conjunctival changes had a maximum score of 20 and iritis had maximum score of 10. The total maximum score was 110. The chemical induced slight eye irritation in treated rabbits after 24 hours. Hence the test chemical was considered to be slightly irritating to the eyes of six rabbits and hence it is likely to classify as an eye irritant.

Based on the data available and applying the weight of evidence approach, it can be concluded that the test chemical is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified as “Category 2 (Irritant)”.

Based on the data available and applying the weight of evidence approach, it can be concluded that the test chemical is able to cause skin and eye irritation and considered as irritating to skin and eyes. Comparing these annotations with the criteria of CLP regulation, it can be classified as “Category 2 (Irritant)” for skin and eye irritation.