Registration Dossier
Registration Dossier
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EC number: 214-686-6 | CAS number: 1185-57-5
Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non Skin Sensitizer”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 of read across substances
- 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: refer below principle
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals.
- GLP compliance:
- not specified
- Type of study:
- other: 2. Human maximization test 3.patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: 2. humans 3.humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 2.
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- 3.
- Concentration / amount:
- 10% aqueous solution of the test chemical
- Day(s)/duration:
- 20 minutes
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- 2.
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- 3.
- Concentration / amount:
- 10% aqueous solution of the test chemical
- Day(s)/duration:
- 20 minutes
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. 702 patients
3. 49 atopic and 56 nonatopic patients - Details on study design:
- no data available
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 708
- Clinical observations:
- No skin allergic reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10% aqueous solution
- No. with + reactions:
- 0
- Clinical observations:
- No immediate (non immunological contact urticaria) reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3.
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical was considered to be not sensitizing to the skin on the basis of summarized studies.
- Executive summary:
Various studies have been reviewed to evaluate the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies performed on humans for the test chemicals. The results are summarized below:
Human maximization test was performed to evaluate the dermal sensitization potential of the test chemical on 702 contact dermatitis patients. The test material was introduced to the subjects by finn chambers applied on the back using Scanpor tape for 48 h.
No positive skin sensitization reactions were observed. Hence, the test chemical was considered to be not sensitizing to human skin.
The above results are further supported by a study performed to determine the degree of contact dermatitis caused when human volunteers were exposed to the test chemical.
49 atopic and 56 nonatopic patients were applied 10% aqueous solution of the test chemical under occlusive conditions and observed for 20 minutes.
No immediate (non immunological contact urticaria) reactions were observed. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data , it can be concluded that the test chemical can be considered 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:
Various studies have been reviewed to evaluate the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies performed on humans for the test chemicals. The results are summarized below:
Human maximization test was performed to evaluate the dermal sensitization potential of the test chemical on 702 contact dermatitis patients. The test material was introduced to the subjects by finn chambers applied on the back using Scanpor tape for 48 h.No positive skin sensitization reactions were observed. Hence, the test chemical was considered to be not sensitizing to human skin.
The above results are further supported by a study performed to determine the degree of contact dermatitis caused when human volunteers were exposed to the test chemical. 49 atopic and 56 nonatopic patients were applied 10% aqueous solution of the test chemical under occlusive conditions and observed for 20 minutes. No immediate (non immunological contact urticaria) reactions were observed. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data , it can be concluded that the test chemical can be considered 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 skin sensitization potential of test substance were observed in various studies. The results obtained from these studies concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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