Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of the study, it didn't use to perform LLNA method
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- IUPAC Name:
- Water
- Reference substance name:
- 9-[(2-hydroxyethyl)amino]-9-oxononanoic acid
- Cas Number:
- 242132-61-2
- Molecular formula:
- C11H21NO4
- IUPAC Name:
- 9-[(2-hydroxyethyl)amino]-9-oxononanoic acid
- Test material form:
- liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% of AZAMIDE, 95% water
- Day(s)/duration:
- Day 0: duration 24h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- other: washing with 10% SDS solution
- Vehicle:
- water
- Concentration / amount:
- 10% SDS; 90% water
- Day(s)/duration:
- Day 7: duration 24h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% AZAMIDE, 75% water
- Day(s)/duration:
- Days 8 and 9: duration 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% AZAMIDE, 95% water
- Day(s)/duration:
- Day 22: duration 24h
- Adequacy of challenge:
- not specified
- Route:
- epicutaneous, occlusive
- Day(s)/duration:
- Days 23-24: washing of the treated area and observation (24-48h)
- No. of animals per dose:
- 30 (20 tested animals, 10 control animals)
- Challenge controls:
- 10 Guinea pigs
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% of AZAMIDE in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% of AZAMIDE in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
There were no mortalities. There was no treatment related alteration of body weight increase. Any consistent evidence of treatment related skin irritation was absent. Any evidence of skin reaction attributable to a sensitizing activity of AZAMIDE was absent. In conclusion the result of this assay indicates that, in our experimental conditions, AZAMIDE is devoid of sensitizing activity in Guinea pig.
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