Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
Endpoint summary
Administrative data
Description of key information
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:
- key study
- Study period:
- Not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Reported as "Annex V (Maximisation test)"
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- other: intradermal - sesame oil and adjuvent mixture; epidermal - vaseline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline
Concentration of test material and vehicle used for each challenge: 10% in vaseline - Route:
- epicutaneous, open
- Vehicle:
- other: intradermal - sesame oil and adjuvent mixture; epidermal - vaseline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline
Concentration of test material and vehicle used for each challenge: 10% in vaseline - No. of animals per dose:
- 20 (test group)
10 (negative control group) - Positive control substance(s):
- not specified
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no evidence of sensitisation at any challenge concentration tested and as such the substance was determined to be a non-sensitiser.
- Executive summary:
In a study conducted in accordance with the Standard Annex V method (Maximisation test) under conditions of GLP, the substance did not elicit any signs of sensitisation at any concentration tested and therefore is considered to be a non-sensitiser.
Reference
Signs of irritation during induction: None
Evidence of sensitisation of each challenge concentration: None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a study conducted in accordance with the Standard Annex V method (Maximisation test) under conditions of GLP, the substance did not elicit any signs of sensitisation at any concentration tested and therefore is considered to be a non-sensitiser.
Migrated from Short description of key information:
Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
Justification for selection of skin sensitisation endpoint:
Only available data source.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the available study summary, the substance does not meet the criteria for classification for skin sensitisation.
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