Registration Dossier
Registration Dossier
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EC number: 423-740-1 | CAS number: 10461-98-0
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from test report
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Maximisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- not specified
- Route:
- other: Intradermal and Topical
- Vehicle:
- other: PEG 400
- Concentration / amount:
- Concentration of test material and vehicle used at induction:a) Intradermal: 5% in PEG 400b) Topical: 100%Concentration of test material and vehicle used for each challenge:100%
- Route:
- other: no data
- Vehicle:
- other: PEG 400
- Concentration / amount:
- Concentration of test material and vehicle used at induction:a) Intradermal: 5% in PEG 400b) Topical: 100%Concentration of test material and vehicle used for each challenge:100%
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 5
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In Guinea pig maximisation test of skin sensitization test substance 2-cyclohexylidene-2-phenylacetonitrile showed negative sensitization effects in test group and negative control group.
- Executive summary:
In Guinea pig maximisation test of skin sensitization test substance 2-cyclohexylidene-2-phenylacetonitrile showed negative sensitization effects in test group and negative control group.
Reference
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction:
Test sites were treated with 10% sodium lauryl sulfate prior to topical induction. No signs of irritation were observed following topical induction.
Evidence of sensitisation of each challenge concentration: None
Other observations: No signs of systemic toxicity were observed in the animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
In Guinea pig maximisation test of skin sensitization test substance 2-cyclohexylidene-2-phenylacetonitrile showed negative sensitization effects in test group and negative control group.
Migrated from Short description of key information:
2-cyclohexylidene-2-phenylacetonitrile is non sensitizing to skin.
Justification for selection of skin sensitisation endpoint:
In Guinea pig maximisation test of skin sensitization test substance 2-cyclohexylidene-2-phenylacetonitrile showed negative sensitization effects in test group and negative control group.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of available information for the test substance it can be considered as not sensitising to the skin, in accordance with the CLP criteria.
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