Registration Dossier
Registration Dossier
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EC number: 264-796-3 | CAS number: 64346-30-1
Endpoint summary
Administrative data
Description of key information
Skin Irritation
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Eye Irritation
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- No data available
- Duration of treatment / exposure:
- No data available
- Observation period:
- No data available
- Number of animals:
- No data available
- Details on study design:
- The overall reactions were categorized -= not irritating and + = irritating.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: NOT SPECIFIED
- 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:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
Various studies have been summarized to evaluate the degree of dermal irritation caused by the test chemical in living organisms. These results include in vivo experimental data for the test chemicals.
The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.
The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
This is supported by the results of another OECD 404 Guideline study performed on rabbits to assess the dermal irritation potential of the test chemical.
The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.
The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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: 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 2. 0.1 ml
3. no data available - Duration of treatment / exposure:
- single
- Observation period (in vivo):
- 2. 1,24,48,72 hours till 8 days
3. no data available - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 2. 3
3. no data available - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Signs of irritation were observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
- Executive summary:
Various studies have been summarized to determine the degree of ocular irritation caused by the test chemical in living organisms. These results include in vivo experimental data for the test chemicals.
An eye irritation test was performed according to Draize method in albino Vienna White rabbits to assess the irritation of the test chemical. 0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from 1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46. Based on the score, test chemical was considered to be moderately to severely irritating to eyes.
This is supported by the results of an OECD 405 Guideline study performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to eyes.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Various studies have been summarized to evaluate the degree of dermal irritation caused by the test chemical in living organisms. These results include in vivo experimental data for the test chemicals.
The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating. Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
This is supported by the results of another OECD 404 Guideline study performed on rabbits to assess the dermal irritation potential of the test chemical. The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating. Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Eye Irritation:
Various studies have been summarized to determine the degree of ocular irritation caused by the test chemical in living organisms. These results include in vivo experimental data for the test chemicals.
An eye irritation test was performed according to Draize method in albino Vienna White rabbits to assess the irritation of the test chemical. 0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from 1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46. Based on the score, test chemical was considered to be moderately to severely irritating to eyes.
This is supported by the results of an OECD 405 Guideline study performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to eyes.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Justification for classification or non-classification
Based on the available results, the test chemical is likely to classify as an Eye irritant under the "Category 2" and is not likely to classify for skin irritation as per CLP Regulation.
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