Registration Dossier
Registration Dossier
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EC number: 263-753-6 | CAS number: 62899-75-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Cyclohexylethylcarbamoyl chloride
- EC Number:
- 263-753-6
- EC Name:
- Cyclohexylethylcarbamoyl chloride
- Cas Number:
- 62899-75-6
- Molecular formula:
- C9H16ClNO
- IUPAC Name:
- N-cyclohexyl-N-ethylcarbamoyl chloride
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Intradermal induction: 5%
Topical induction: 100%
Challenge: 20% and 5%
Challengeopen allclose all
- Route:
- other: Intradermal and Topical induction
- Vehicle:
- corn oil
- Remarks:
- induction and the challenge treatment
- Concentration / amount:
- Intradermal induction: 5%
Topical induction: 100%
Challenge: 20% and 5%
- No. of animals per dose:
- 9
- Challenge controls:
- 5 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 9.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5%. No with. + reactions: 9.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 9.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 20%. No with. + reactions: 9.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
The challenge using 5% and 20% test substance formulations led to skin effects in all animals which could be evaluated in the treatment group and in none of the animals in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test substance therefore thus exhibits a skin-sensitization potential.
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