Registration Dossier
Registration Dossier
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EC number: 266-885-2 | CAS number: 67674-46-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- other company data
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Open epicutaneous test
- GLP compliance:
- no
- Remarks:
- study pre-dates introduction of GLP
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- LLNA no available at time of testing
Test material
- Reference substance name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- EC Number:
- 266-885-2
- EC Name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- Cas Number:
- 67674-46-8
- Molecular formula:
- C11H22O2
- IUPAC Name:
- 6,6-dimethoxy-2,5,5-trimethylhex-2-ene
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): LRG 1393 = Methyl pamplemousse
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Main test:
- Induction phase: 100, 30, 10 and 3 %
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Main Test
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations
- No. of animals per dose:
- 6 animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Test groups: Open epicutaneous application of 0.1 mL of each test concentration (100, 30, 10, and 3 %)
- Control group: No treatment or topical (uncovered) application of 0.1 mL of vehicle (ethanol)
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. When very strong skin reactions were provoked, the application sites were changed.
- Duration: Days 0-20
- Evaluation: Dermal reactions were recorded at 24 h after each application or at the end of each week and the minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 21 and 35
- Test and control groups: Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material
- Site: Contralateral flank (2 cm2)
- Evaluation (h after challenge): 24, 48 and/or 72 h - Challenge controls:
- Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on control animals during challenge phase.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No positive reaction was observed after challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Methyl pamplemousse was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs were topically (uncovered) induced with 0.1 mL of Methyl pamplemousse at doses of 100, 30, 10, and 3 % diluted in ethanol and applied on clipped flank skin (8 cm2), daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. The application sites were changed if very strong skin reactions were provoked. At least 6 animals were used in each treatment group and 10 animals in control group. On Days 21 and 35, an open epicutaneous challenge application of 0.025 mL of all tested concentrations of the test material was performed on the contralateral flank (2 cm2) of the animals and the dermal reactions were recorded after 24, 48 and/or 72 h.
Under the test conditions, Methyl pamplemousse was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
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