Registration Dossier
Registration Dossier
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EC number: 946-958-1 | CAS number: -
Skin sensitisation
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:
- 1 979
- 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
- 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
- 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
Constituent 1
Constituent 2
- 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%.
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