Registration Dossier
Registration Dossier
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EC number: 201-158-5 | CAS number: 78-92-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- -reliability scoring based on 1987 guideline
- Deviations:
- yes
- Remarks:
- -insignificant deviation, guideline suggests using animals of all the same sex
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Butan-2-ol
- EC Number:
- 201-158-5
- EC Name:
- Butan-2-ol
- Cas Number:
- 78-92-2
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 227 to 265 g (males) and 153 to 170 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum; however, food was withheld 24 hours after administration
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: not reported
- Type of wrap if used: The test material was covered with a piece of aluminum foil which was held in place by a double over-wrap of waterproof adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the tape and foil were carefully removed and the skin was washed with warm dilute detergent solution and then dried.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): undiluted
- Constant volume or concentration used: not applicable
- For solids, paste formed: not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for signs of toxicity for 14 days after dosing. Body weights were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs and body weight - Statistics:
- Statistical analysis was not performed, but is not required.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: The LD50 value was not determined since none of the rats died at a dose level of 2000 mg/kg bw. The LD50 value was predicted to be greater than 2000 mg/kg bw.
- Mortality:
- None of the rats died over a period of 14 days.
- Clinical signs:
- other: There were no clinical signs seen.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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