Registration Dossier

Administrative data

Description of key information

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".

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:
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
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
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
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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)”.

Justification for classification or non-classification

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.