Registration Dossier
Registration Dossier
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EC number: 255-901-3 | CAS number: 42594-17-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1992-01-16 to 1992-02-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Before the REACH registration, a conclusive and reliable study to evaluate the skin sensitisation potential of the registered substance is available on guinea pigs. No other test is required fot this endpoint.
Test material
- Reference substance name:
- (octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate
- EC Number:
- 255-901-3
- EC Name:
- (octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate
- Cas Number:
- 42594-17-2
- Molecular formula:
- C18H24O4
- IUPAC Name:
- octahydro-1H-4,7-methanoindene-1,1-diylbis(methylene) bisacrylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): T-acrylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: ethanol
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml 5% test item in FCA.
For control: 0.05 ml FCA only. - Day(s)/duration:
- Day 1, 5 and 9
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1, 0.3, 1 and 3%
0.025 ml of test item/2cm² - Day(s)/duration:
- Day 21 and 35
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5
- Details on study design:
- 0.1 ml of a 5% dilution of the test article in vehicle mixed with the same volume of Freund's Complete Adjuvant were injected intradermally into the guinea pig flanks on days 1, 5 and 9. The experimental animals and controls (pretreated with 0.05 ml of FCA only) were tested epicutaneously on day 22. This challenge test was performed by applying 0.025 ml of each test concentration to skin areas of 2 cm². Skin reactions were read 24, 48 and 72 hours after application of the test material.
- Challenge controls:
- no
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 - 0.3 - 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Same results were observed at 48h and 72h.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- This concentration (3%) is considered to be irritating. Same results observed at 48h and 72h.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- Same results were observed at 48h and 72h.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- Same results were observed at 48h and 72h.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% and 3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- Same results were observed at 48h and 72h.
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The highest non-irritating concentration applied at the pre-treatment was 1%.
The test article is considered as being allergenic when 1 out of 5 animals of the experimental group shows positive reactions to primary non-irritating concentration used for challenge.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer in guinea pigs.
- Executive summary:
In this skin sensitisation test, 0.1 ml of a 5% dilution of the test article in vehicle mixed with the same volume of Freund's Complete Adjuvant were injected intradermally into the guinea pig flanks on days 1, 5 and 9. The experimental animals and controls (pretreated with 0.05 ml of FCA only) were tested epicutaneously on day 22. This challenge test was performed by applying 0.025 ml of each test concentration to skin areas of 2 cm². Skin reactions were read 24, 48 and 72 hours after application of the test material.
The highest non-irritating concentration applied at the pre-treatment was 1%.
The test article is considered as being allergenic when 1 out of 5 animals of the experimental group shows positive reactions to primary non-irritating concentration used for challenge. According to the findings observed it must be considered that the test substance showed positive allergenic reactions at the primary highest non-irritating concentration of 1% (5/5, 100%) and at the non-irritating concentrations of 0.3% (4/5, 80%) and 0.1% (2/5, 40%) diluted in ethanol. The effects observed at the 3% concentration level must be considered as acute irritation, because in a pre-test the highest non-irritating concentration was found to be 1% of test item diluted in ethanol.
Based on the results of the FCA test, Tricyclododecane dimethanol diacrylate is considered to be a skin sensitizer in guinea pigs.
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