Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- 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: The study was conducted comparable to EU Guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- No positive control animals were used, different vehicles were used for induction and challenge exposure.
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Test material form:
- other: granular solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Redfern Animal Breeders, Brenchley, Kent
- Age at study initiation: young
- Weight at study initiation: 300-400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- other: induction: aqueous ethanol, challenge: acetone
- Concentration / amount:
- concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- other: induction: aqueous ethanol, challenge: acetone
- Concentration / amount:
- concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
- No. of animals per dose:
- 20 (10 male and 10 female)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals
- Control group: 10 animals
- Frequency of applications: weekly intervals
- Duration: 6 hours
- Concentrations: 0.1 % (w/v)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction application (on Day 28)
- Exposure period: one application (6 h duration)
- Concentrations: 0.1 % (w/v)
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- no data
- 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:
- 0.1 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
