Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- -
- EC Number:
- 400-820-2
- EC Name:
- -
- Cas Number:
- 84268-33-7
- Molecular formula:
- C20H23N3O3
- IUPAC Name:
- methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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
Challengeopen allclose all
- 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
Results and discussion
Any other information on results incl. tables
Signs of irritation during induction: None
Evidence of sensitisation of each challenge concentration: None
Applicant's summary and conclusion
- 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.
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