Registration Dossier
Registration Dossier
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EC number: 600-715-3 | CAS number: 106092-09-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.11.1994 to 16.12.1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea Pig Maximization Test of Magnusson and Kligman
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- checked and confirmed
- IUPAC Name:
- checked and confirmed
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25 % in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25 % in ethanol
- No. of animals per dose:
- Group 1: 10 animals, negative control group
Group 2: 20 animals, 0.1 ml of 0.25 % test suspension - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- max 0.6 ml 25 % test compound in ethanol
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: max 0.6 ml 25 % test compound in ethanol. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- max 0.6 ml 25 % test compound in ethanol
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: max 0.6 ml 25 % test compound in ethanol. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.3 ml 25 % test compond in ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.3 ml 25 % test compond in ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 ml 25 % test compound in ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.3 ml 25 % test compound in ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: mild sensitization potential (Grade II)
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- According to the classification scheme of Magnusson and Kligman the test compound SND 855 BS Y has to be classified as a substance with a mild sensitization potential (Grade II) based on the 12 % positive reactions registered under the stated study conditions.
According to the German Chemicals Act the compound SND 855 BS Y has not to be classified as a sensitizer and no labelling is necessary. - Executive summary:
According to the classification scheme of Magnusson and Kligman the test compound SND 855 BS Y has to be classified as a substance with a mild sensitization potential (Grade II) based on the 12 % positive reactions registered under the stated study conditions. According to the German Chemicals Act the compound SND 855 BS Y has not to be classified as a sensitizer and no labelling is necessary.
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