Registration Dossier
Registration Dossier
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EC number: 205-778-7 | CAS number: 150-90-3
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Eye Irritation:
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
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 similar test chemicals
- Justification for type of information:
- Weight of evidence approach based on similar 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 similar test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on similar test chemicals
- GLP compliance:
- not specified
- Species:
- other: 1. guinea pigs; 2. rabbits
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1. 50% test chemical in propylene glycol
2. undiluted - Duration of treatment / exposure:
- single exposure
- Observation period:
- no data available
- Number of animals:
- 1. 10
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:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 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.
Skin irritation study of the test chemical was performed on intact skin of ten guinea pigs to assess its skin irritation potential. 50% test chemical in propylene glycol was applied to the intact skin of ten guinea pigs and later observed for skin reactions. Since none of the guinea pigs showed any signs of skin irritation, the test chemical was considered to be not irritating to the skin of guinea pigs.
The above study is supported by the experimental study summarized for the test chemical which was performed according to the EEC method described in the annex to directive 92/69/EEC, part B, Method B4 to assess its irritation potential. The test chemical was applied to rabbit skin and observed for signs of irritation(dose, duration of exposure and observation period not mentioned),
The test chemical was described as not irritating in the rabbit test.
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
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 similar test chemicals
- Justification for type of information:
- Weight of evidence approach based on similar 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 similar test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on similar test chemicals
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1. Approximately 70 mg of the test substance, the weight occupying a volume of 0.1 ml
2. no data available - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1. 2 days
2. no data available - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1. 0.1 ml
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:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 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. Approximately 70 mg of the test substance, the weight occupying a volume of 0.1 ml was instilled in the eyes of rabbits and observed for signs of irritation till 2 days.No corneal damage or iridal inflammation was observed. One hour after instillation, conjunctiva redness and conjunctiva chemosis scores were 2.After one day the conjunctival redness score decreased to grade 1 and the eyes were normal after 2 days. The transient, benign irritation was attributed to the mechanical effects than the chemical(since it has neutral range pH).
Hence, the test chemical can be considered to not irritating to rabbit eyes.
The ocular irritation potential of the test chemical was assessed in a primary irritation in rabbits.
The test chemical was instilled into the eyes of rabbits and observed for effects.
No signs of irritation were observed. Hence, the test chemical was considered to be not irritating to rabbit eyes in a primary eye irritation study.
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
The skin irritation potential of the test chemical was assessed based on the available results from the various test chemicals.
Skin irritation study of the test chemical was performed on intact skin of ten guinea pigs to assess its skin irritation potential.50% test chemical in propylene glycol was applied to the intact skin of ten guinea pigs and later observed for skin reactions.
Since none of the guinea pigs showed any signs of skin irritation, the test chemical was considered to be not irritating to the skin of guinea pigs.
The above study is supported by the experimental study summarized for the test chemical which was performed according to the EEC method described in the annex to directive 92/69/EEC, part B, Method B4 to assess its irritation potential.
The test chemical was applied to rabbit skin and observed for signs of irritation(dose, duration of exposure and observation period not mentioned),
The test chemical was described as not irritating in the rabbit test.
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Eye Irritation:
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. Approximately 70 mg of the test substance, the weight occupying a volume of 0.1 ml was instilled in the eyes of rabbits and observed for signs of irritation till 2 days.
No corneal damage or iridal inflammation was observed. One hour after instillation, conjunctiva redness and conjunctiva chemosis scores were 2. After one day the conjunctival redness score decreased to grade 1 and the eyes were normal after 2 days. The transient, benign irritation was attributed to the mechanical effects than the chemical(since it has neutral range pH).Hence, the test chemical can be considered to not irritating to rabbit eyes.
The ocular irritation potential of the test chemical was assessed in a primary irritation in rabbits.
The test chemical was instilled into the eyes of rabbits and observed for effects.
No signs of irritation were observed. Hence, the test chemical was considered to be not irritating to rabbit eyes in a primary eye irritation study.
Based on the available data for the test chemicals and applying the weight of evidence approach, the test chemical was not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Justification for classification or non-classification
The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not irritating to skin and eyes.
Hence, by applying the weight of evidence approach,the test chemicalcan be considered to be not irritating to skin and eyes. It can be classified under the category “Not Classified” as per CLP regulation.
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