Registration Dossier
Registration Dossier
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EC number: 214-901-3 | CAS number: 1208-67-9
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. The test chemical 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:
- 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:
- Weigth of evidence approach based on various test chemicals
- Justification for type of information:
- Weigth 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 test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on test chemicals
- Species:
- other: 1, 2. guinea pigs;3. humans
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 42.8%
- Adequacy of induction:
- not specified
- Route:
- other: no data available
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 42.8%
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: not mentioned
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. no data available
2. 20
3. no data available - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no signs of sensitization 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. The test chemical 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 skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Buehler test was conducted to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD Guideline 406 Guidelines. 20 Dunkin Hartley guinea pigs were used for the study.
In induction, the animals were induced dermally at concentration of 42.8 %. After induction, animals were challenged dermally with the same concentration under occlusive conditions (duration of exposure not mentioned). The guinea pigs were observed for signs of dermal irritation and sensitization (observation duration not mentioned).
No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.
This is supported by the results of skin sensitization study performed in 20 guinea pigs to observed its sensitizing potential by guinea pig maximization test.
The test chemical failed to induce any signs of dermal sensitization through out the test duration. Hence, the test chemical can be considered to be not sensitizing to skin.
The above results are further supported by the results of Human repeat insult patch performed to assess the dermal sensitization potential of the test chemical. 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin and observed for dermal reactions(duration not mentioned). No evidence of dermal sensitization was observed when 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin. Hence, the test chemical can be considered to be not sensitizing 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 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 skin sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
Buehler test was conducted to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD Guideline 406 Guidelines. 20 Dunkin Hartley guinea pigs were used for the study.
In induction, the animals were induced dermally at concentration of 42.8 %. After induction, animals were challenged dermally with the same concentration under occlusive conditions (duration of exposure not mentioned). The guinea pigs were observed for signs of dermal irritation and sensitization (observation duration not mentioned).
No known skin reactions were observed at induction as well as at challenge exposure. Thus the test chemical was considered to be not sensitizing to the skin of Dunkin Hartley guinea pigs.
This is supported by the results of skin sensitization study performed in 20 guinea pigs to observed its sensitizing potential by guinea pig maximization test.
The test chemical failed to induce any signs of dermal sensitization through out the test duration. Hence, the test chemical can be considered to be not sensitizing to skin.
The above results are further supported by the results of Human repeat insult patch performed to assess the dermal sensitization potential of the test chemical. 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin and observed for dermal reactions(duration not mentioned). No evidence of dermal sensitization was observed when 0.5% aqueous solution of the test chemical in 0.1% aqueous granular detergent was exposed to human skin. Hence, the test chemical can be considered to be not sensitizing 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 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 chemical can be considered to be not sensitizing to skin.
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