Registration Dossier
Registration Dossier
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EC number: 267-140-4 | CAS number: 67801-20-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols with no minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol
- EC Number:
- 267-140-4
- EC Name:
- 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol
- Cas Number:
- 67801-20-1
- Molecular formula:
- C14H24O
- IUPAC Name:
- 3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-2-ol
- Details on test material:
- IUPAC name : 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)-4-penten-2-ol
Molecular formulae : C14H24O
CAS number : 67801-20-1
EINECS number : 267-140-4
Description : Pale yellow liquid
Batch number : VE00071661
Purity : 96% (sum of isomers)
Storage conditions : Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Harlan Laboratories UK Ltd.
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: At least 200 g
- Fasting period before study: N/A
- Housing: Individually
- Diet (e.g. ad libitum): 2014 Tekland Global Rodent Diet
- Water (e.g. ad libitum): Mains supply
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour/ 12 hours
IN-LIFE DATES: From: To:17 March 2010 - 31 March 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: 10 % of the total body surface
- Type of wrap if used: Surgical gauze placed overtreatment area and semi-occluded with a piece of self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.26 mL/kg
- Concentration (if solution): Neat
- Constant volume or concentration used: Yes
- For solids, paste formed: No
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of exposure:
- 24 hour
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- not required
- Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations and weighing: 0.5, 1, 2, 4 hours and once daily on sebsequent days
Necropsy of survivors performed: Yes
Other examinations performed: clinical signs, body weight,organ weights. - Statistics:
- Not required.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no unscheduled deaths during the study.
- Clinical signs:
- other: None observed.
- Gross pathology:
- There were no treatment-related macroscopic abnormalities detected at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
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