Registration Dossier
Registration Dossier
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EC number: 208-156-3 | CAS number: 513-35-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylbut-2-ene
- EC Number:
- 208-156-3
- EC Name:
- 2-methylbut-2-ene
- Cas Number:
- 513-35-9
- Molecular formula:
- C5H10
- IUPAC Name:
- 2-methylbut-2-ene
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl-2-butene
- Physical state: Strong smelling, colourless liquid with a specific gravity of 0.66
- Stability under test conditions: Stable for duration of experiment, expiry date 1 January 1981
- Storage condition of test material: In fridge
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit, Tunstall, UK
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 260-366 g males, 177-248 g females
- Fasting period before study: 18 hours
- Housing: Individually for the duration of the dermal application, 3 per cage thereafter in hanging polypropylene cages with stainless steel wire mesh floors and tops (33 x 21 x 17 cm)
- Diet: PRD (Labsure Animal Foods Ltd) ad libitum (except for the duration of the dermal application)
- Water: Filtered public supply ad libitum
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 50-60%
- Air changes (per hr): Not reported
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 7 May 1980 To: 18 July 1980
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 60% of the dorsal area.
- Preparation of skin site: 24 hours prior to application site closely shorn with electric clippers.
- Type of wrap if used: Aluminium foil held in place by a double overwrap of waterproof adhesive tape.
DOSING:
- Dose levels selected following a range-finding test in which 2 rats/sex/group were given a single dermal dose at 0.5, 1.0 or 2.0 mL/kg.
- Due to volatility of 2-methyl-2-butene, it was stored on ice, temperature of substance at dosing was approximately 5°C.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm dilute detergent.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.03 mL/kg bw. - Duration of exposure:
- 24 hours
- Doses:
- 3.03 mL/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations daily, bodyweights initial, days 7 and 14
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3.03 mL/kg bw
- Remarks on result:
- other: >2000 mg/kg
- Mortality:
- No mortalities
- Clinical signs:
- other: Some animals bled from the nose on day 1 and many of the animals had sores and scabs on their backs
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of 2-methyl-2-butene to male and female rats was >2000 mg/kg.
- Executive summary:
The acute dermal LD50 of 2 -methyl-2 -butene to male and female rats was >3.03 mL/kg (>2000 mg/kg).
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