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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:
weight of evidence
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Guninea pig maximisation test
Deviations:
not specified
Principles of method if other than guideline:
Guinea pig maximisation test (GPMT) developed by Kligman and Magnusson to identify contact allergens in humans and animals.
The Open Epicutaneous Test (OET) was developed using the knowledge of the GPMT for testing new chemicals and cosmetics.
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
The Open Epicutaneous Test (OET) is an acceptable method for contact allergens for cosmetic ingredients.

Test material

Constituent 1
Reference substance name:
Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
IUPAC Name:
Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
Constituent 2
Reference substance name:
RIFM 71-6-32
IUPAC Name:
RIFM 71-6-32
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): RIFM 71-6-32 Aurantium
Specific details on test material used for the study:
Sample: Aurantiol (Hydroxycitronellal - Methyl Anthranilate)

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Guinea pigs - no further details provided

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
polyethylene glycol
Concentration / amount:
6%
Day(s)/duration:
24 hours
Adequacy of induction:
highest technically applicable concentration used
Challenge
Route:
epicutaneous, open
Vehicle:
polyethylene glycol
Concentration / amount:
6%
No. of animals per dose:
six to eight
Details on study design:
RANGE FINDING TESTS: Irritation test to determine the minimum irritating concentration and the maximal tolerated dose after a single application by simultaneously applying 4 different concentrations to the left flank of a special animal group.
After 24 hours, the maximal non-irritating concentration was defined as the highest one not inducing macroscopic reactions.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: Flank
- Frequency of applications: Once
- Duration: 24 hours
- Concentrations: 6%
Positive control substance(s):
no

Results and discussion

Positive control results:
Results were reported for all 190 chemicals.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, Aurantiol Pure was non sensitising when tested at a concentration of 6%.
Executive summary:

Aurantiol Pure is reported to be non-sensitising to skin when tested using the OET method at a concentration of 6%.