Registration Dossier
Registration Dossier
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EC number: 805-440-4 | CAS number: 22972-51-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-02-25 to 2019-03-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Cas Number:
- 22972-51-6
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Test item: (1S,4R)-1-Methyl-4-(prop-1-en-2-yl)cyclohex-2-enol
CAS number: 22972-51-6
Physical state: Liquid
Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Test item: (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol (PMDOL)
CAS number: 22972-51-6
Physical state: Liquid
Storage: room temperature
Batch No. 118000-182001
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BipLasco Taiwan CO., Ltd.
- Females: nulliparous and non-pregnant
- Age at study initiation: 10 weeks
- Weight at study initiation: Animals of comparable weight (226-245g)
- Fasting period before study: no
- Housing: Single housing
- Diet ad libitum
- Water ad libitum
- Acclimation period: 8 days before starting the experiment
ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C
- Humidity: 50 +/- 20 %
-Lighting: 12 hours (06:00 on, 18:00 off)
Administration / exposure
- Vehicle:
- cotton seed oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: ca. 10%
- Type of wrap: The test item was covered with a porous gauze dressing and non-irritant tape
REMOVAL OF TEST SUBSTANCE:
Rinsing off the test article with sterile water after 24 hours of the treatment
TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 500mg/ mL - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 2 females
- Details on study design:
- - Duration of observation period following administration: up to 14 days
- Frequency of observations and weighing: Individual body weights prior to administration (day 0), once a week thereafter during the study period. Clinical signs for each animal were recorded twice after administration and once daily.
- Necropsy of survivors performed: yes. Gross findings were recorded
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Systemic effects: No systemic clinical signs were observed during clinical examination. Local effects: No local effects were observed.
- Gross pathology:
No significant gross lesion in the treated animals (2 females).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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