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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
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

Constituent 1
Reference substance name:
Reference substance 001
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