Registration Dossier
Registration Dossier
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EC number: 441-070-6 | CAS number: 61826-76-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study report from 2002 readily available
Test material
- Reference substance name:
- -
- EC Number:
- 441-070-6
- EC Name:
- -
- Cas Number:
- 61826-76-4
- Molecular formula:
- C14H11NO2
- IUPAC Name:
- (2S)-2-hydroxy-2-(3-phenoxyphenyl)acetonitrile
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 1% / 0.1 mL
- Day(s)/duration:
- Day 0 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 50% / 0.5 mL
- Day(s)/duration:
- Day 7 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- No mortality/adverse signs of toxicity occurred
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- No mortality/adverse signs of toxicity occurred
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No mortality/adverse signs of toxicity occurred
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No mortality/adverse signs of toxicity occurred
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
- All animals survived till the end of the study.
- No differences in the mean body weight between the animals of the test substance and negative control group on Days 0 and 23.
- No abnormal behaviour or clinical signs were detected during the experiment
Skin reactions after the challenge exposure:
In the test substance group very slight to severe erythema and/or edema were noted in 4/10 animals at the test substance areas 24 and 48 hours after the end of the challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In conclusion, in an in vivo skin sensitisation test conducted in accordance with OECD 406 the test material showed a sensitising potential.
- Executive summary:
In conclusion, in an in vivo Guinea pig maximisation test conducted in accordance with OECD 406, the test material showed a sensitising potential.
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