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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- reported as "other guideline: Annex V (Maximisation test)"
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1986 before the Local Lymph Node Assay (LLNA; TG 429) was adopted (2002).
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
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 and epicutaneous
- Vehicle:
- other: intradermal: sesame oil and adjuvant mixture, epidermal & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
1% in sesame oil and in adjuvant mixture (intradermal).
20% in vaseline (epidermal).
- Concentration of test material and vehicle used for each challenge:
10% in vaseline.
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- other: intradermal: sesame oil and adjuvant mixture, epidermal & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
1% in sesame oil and in adjuvant mixture (intradermal).
20% in vaseline (epidermal).
- Concentration of test material and vehicle used for each challenge:
10% in vaseline.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- The test incorporated pretreatment with 10% sodium lauryl sulfate prior to epidermal induction.
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- other: quantitative result not determined; no signs of irritation during induction; no evidence of sensitisation of each challenge concentration
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- On the basis of these results and under the experimental conditions the test substance did not appear to possess sensitising capacity.
- Executive summary:
The test substance was tested to be non sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.
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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