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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
predates the adoption of the REACH legislation and the development of the LLNA and in vitro methods.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1963-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
CIR: Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., U.S.A.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Intradermal injections only for both induction and challenge phases
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Test predates adoption of LLNA as standard method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
Glycol stearate is comprised primarily of the mono- and diesters of triple-pressed stearic acid. Impurities include free stearic acid (triple-pressed), ethylene glycol, and corresponding derivatives of other fatty acids.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.05 ml
Day(s)/duration:
Initial injection on Day 1
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 mL
Day(s)/duration:
Three times a week for a total of ten injections
Challenge
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
2
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 1 group of 2 white male guinea pigs
- Control group: not specified
- Site: shaved back
- Frequency of applications: 3 injections/week
- Duration: 3 weeks
- Concentrations: Initial injection was 0.05 mL, following injections were 0.1 mL

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 2 weeks
- Site: shaved back
- Concentrations: not specified
- Evaluation (hr after challenge): 24

OTHER:
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
2
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Not sensitising in a protocol which used intradermal injection only for both induction and challenge. No epicutaneous exposure is noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
the test substance is not sensitising. This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence demonstrating that the test substance lacks potential to be a skin sensitiser.