Registration Dossier
Registration Dossier
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EC number: 229-851-8 | CAS number: 6786-83-0
Endpoint summary
Administrative data
Description of key information
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
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:
- 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
- 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. The study 2,3 are referrred as study 1,2
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Justification for non-LLNA method:
- Currently no LLNA Study is available for assessment.
- Species:
- other: 1. guinea pigs; 2. humans
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- three times weekly (Monday, Wednesday Friday) for three consecutive weeks
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% in water on Mondays, Wednesdays and Fridays, total 10 applications
- Day(s)/duration:
- 24 hours- Mondays, Wednesdays and Fridays, total 10 applications
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 10.0%, 5.0%, and 2.5%.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% in water on Mondays, Wednesdays and Fridays, total 10 applications
- Day(s)/duration:
- 24 hours- Mondays, Wednesdays and Fridays, total 10 applications
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 10 guinea pigs
2. 50 human volunteers - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no signs of sensitization were observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
- Executive summary:
Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, guinea pigs for the test chemicals.
Skin sensitization study for test chemical was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing.
For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. After a rest period of two weeks. In challenge phase the right flank of each guinea pig was shaved and exposed to three different concentration10.0%, 5.0%, and 2.5%.Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test chemical was considered to be not sensitizing to the skin of guinea pig using modified Buehler and Klecak method for open Epicutaneous testing .
This is supported by the results of a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.
Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation. After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later. Since there was no evidence of any contact sensitization, the chemical was considered to be notsensitizingon skin of human subjects.
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- The study is ongoing and this information will be submitted later based on ECHA communication/decision number CCH-D-2114554511-55-01/F.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, guinea pigs for the test chemicals.
Skin sensitization study for test chemical was conducted in guinea pig using modified Buehler and Klecak method for open Epicutaneous testing.
For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. After a rest period of two weeks. In challenge phase the right flank of each guinea pig was shaved and exposed to three different concentration 10.0%, 5.0%, and 2.5%.Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
No erythema/edema was observed after application of test material .The test result was observed to be negative for the test substance. Therefore the test chemical was considered to be not sensitizing to the skin of guinea pig using modified Buehler and Klecak method for open Epicutaneous testing .
This is supported by the results of a human repeated insult patch test conducted on 50 subjects to assess the contact sensitization caused by the chemical under occlusive condition.
Induction was carried out at a dose of 5% in water on Mondays, Wednesdays and Fridays, total 10 applications were made. After 24 hours patches were removed and skin sits were scored for primary irritation. After a rest period of 10-14 days, a challenge patch was applied (to the same site, an adjacent site or both). After 24 hours the patches were removed and the sites were examined for reactions immediately and 24 and 48 hours later. Since there was no evidence of any contact sensitization, the chemical was considered to be notsensitizingon skin of human subjects.
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
However the final classification will be given based on the results from OECD 442C &D study, as it was ongoing currently.
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