Registration Dossier
Registration Dossier
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EC number: 231-832-4 | CAS number: 7758-09-0
Endpoint summary
Administrative data
Description of key information
Based on the available results and applying the weight of evidence approac, the test chemical can be considered to be not likely to be sensitizing to skin. Therefore, the test chemical can be 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
- 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
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- no data available
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 2. No data available
- Route:
- other: not specified
- Vehicle:
- not specified
- Remarks:
- study 2
- Concentration / amount:
- no data available
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Study 3
- Concentration / amount:
- 95%
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: not specified
- Vehicle:
- not specified
- Remarks:
- study 2
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Study 3
- Concentration / amount:
- 95%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. No data available
3. 25 guinea pigs
(10 test guinea pigs, 10 negative controls, and 5 positive controls) - Details on study design:
- 2. No data available
3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups:10
- Control group: 10
- Site: no data
- Frequency of applications: no data .
- Duration: 3 weeks
- Concentrations: 95%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 3 weeks
- Exposure period: 24 hours
- Test groups: 10
- Control group: 10
- Site: no data .
- Concentrations: 95%
- Evaluation (hr after challenge): 24 hours - Challenge controls:
- 2. No data available
3. Yes concurrent vehicle were used. - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene served as positive control.
- 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 results and applying the weight of evidence approach, the test chemical can be considered to be not likely to be sensitizing to skin. Therefore, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
- Executive summary:
Various studies have been performed to evaluate the dermal sensitization potential of the test chemical. The results are summarized below:
Buehler test was performed to evaluate the dermal sensitization potential of the test chemical. The study was performed according to OECD 406 Guidelines. No dermal reactions were observed at the treatment sites of the test animals after exposure to the test chemical. Hence, the test chemical can be considered to be not sensitizing to skin.
The above result is supported by another Buehler test conducted on guinea pigs to determine the skin sensitization potential to test chemical.10 test guinea pigs, 10 negative controls, and 5 positive controls were used for the study. During induction, the test chemical moistened with distilled water was applied for 24 h, under occlusive patch at a concentration of 95% over a period of 3 weeks. Later the animals were challenged with same concentration and observed for skin reactions. The chemical failed to induce skin sensitization in treated guinea pigs and hence the test substance was considered as not sensitizing to the skin of Guinea pigs.
Based on the available results and applying the weight of evidence approac, the test chemical can be considered to be not likely to be sensitizing to skin. Therefore, the test chemical can be 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 performed to evaluate the dermal sensitization potential of the test chemical. The results are summarized below:
Buehler test was performed to evaluate the dermal sensitization potential of the test chemical. The study was performed according to OECD 406 Guidelines. No dermal reactions were observed at the treatment sites of the test animals after exposure to the test chemical. Hence, the test chemical can be considered to be not sensitizing to skin.
The above result is supported by another Buehler test conducted on guinea pigs to determine the skin sensitization potential to test chemical.10 test guinea pigs, 10 negative controls, and 5 positive controls were used for the study. During induction, the test chemical moistened with distilled water was applied for 24 h, under occlusive patch at a concentration of 95% over a period of 3 weeks. Later the animals were challenged with same concentration and observed for skin reactions. The chemical failed to induce skin sensitization in treated guinea pigs and hence the test substance was considered as not sensitizing to the skin of Guinea pigs.
Based on the available results and applying the weight of evidence approac, the test chemical can be considered to be not likely to be sensitizing to skin. Therefore, the test chemical can be 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
Based on the available results and applying the weight of evidence approac, the test chemical can be considered to be not likely to be sensitizing to skin. Therefore, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
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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