Registration Dossier
Registration Dossier
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EC number: 900-064-8 | CAS number: -
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 and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Acryloxibutylchlorformiat
- IUPAC Name:
- Acryloxibutylchlorformiat
- Details on test material:
- - Name of the test substance used in the study report: Acryloxibutylchlorformiat
- Purity: ca. 75%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Young adult female animals with a body weight range of 297 - 349 g were used.
Acclimatization period: 7 days before study start
The animals were housedin fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
Five animals per cage (type IV, Makrolon); animal identification via ear tag numbering.
The animals were offered a standardized animal laboratory diet as well as tap water (with 2 g of ascorbic acid per 10 l water) ad libitum.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal induction: 0.1%
epicutaneous induciton: 5%
challenge: 2%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal induction: 0.1%
epicutaneous induciton: 5%
challenge: 2%
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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