Registration Dossier
Registration Dossier
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EC number: 254-599-0 | CAS number: 39711-79-0
Endpoint summary
Administrative data
Description of key information
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 and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 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
- 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
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Justification for non-LLNA method:
- not specified
- Species:
- other: 1. guinea pigs; 2,3. humans
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Day(s)/duration:
- 30 sec once daily for 3x5 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 20 guinea pigs
2. 25 volunteers
3. 24 volunteers - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Challenge controls:
- The data is based on weight of evidence approach based on various test chemicals
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- 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 and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
An open repetitive dermal test of the test chemical was conducted on guinea pigs to examine the contact sensitization caused by the chemical. 20 guinea pigs were used for the study.
The test chemical was rubbed into shaved skin for 30 sec once daily for 3x5 days. After 5 days without application, the test substance was rubbed into an untreated part of the skin. Skin lesions were examined after 24 h, 2 and 3 days.
No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
This is supported by the results of a human maximisation test carried out to determine skin sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
These results are further supported by another Human maximisation test conducted on 24 volunteers to assess the skin sensitization potential of test chemical. Each subject was treated with 8% in petrolatum dermally and later observed for any signs of contact allergy. Since the chemical not induce any skin sensitizing effects in treated volunteers, the test chemical was considered to be not sensitizing to the skin of 24 human volunteers.
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 and was estimated to be not sensitizing 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 sensitising)
- Additional information:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
An open repetitive dermal test of the test chemical was conducted on guinea pigs to examine the contact sensitization caused by the chemical. 20 guinea pigs were used for the study.
The test chemical was rubbed into shaved skin for 30 sec once daily for 3x5 days. After 5 days without application, the test substance was rubbed into an untreated part of the skin. Skin lesions were examined after 24 h, 2 and 3 days.
No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
This is supported by the results of a human maximisation test carried out to determine skin sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
None of the volunteers showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
These results are further supported by another Human maximisation test conducted on 24 volunteers to assess the skin sensitization potential of test chemical. Each subject was treated with 8% in petrolatum dermally and later observed for any signs of contact allergy. Since the chemical not induce any skin sensitizing effects in treated volunteers, the test chemical was considered to be not sensitizing to the skin of 24 human volunteers.
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 and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 sensitizing to skin.
Hence, by applying the weight of evidence approach,the test chemicalcan be considered to be not sensitizing to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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