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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1996
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
no data
Author:
Elf Atochem
Year:
1996
Bibliographic source:
cited in OECD SIDS Final 08/02

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study was conducted before implementation of LLNA-method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- purity: 99.2 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.1 %
Day(s)/duration:
day 1 / 7 days
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg
Day(s)/duration:
day 8 / 48 h
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 12 days
- Control group: treatment with vehicle only
- Site: intradermal injection in the dorsal region between the shoulders, topical application to the same site
- Frequency of applications: day 1 and day 8
- Duration: 12 days
- Concentrations: 0.1 % in vehicle for intradermal injection and 500 mg undiluted test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24 h
- Exposure period: 24 h
- Control group: treatment with vehicle only
- Concentrations: 500 mg undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after challenge application

Results and discussion

In vivo (non-LLNA)

Results
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met