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EC number: 279-420-3 | CAS number: 80206-82-2
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Acute dermal toxicity (LD50) in rabbits
- Author:
- Veenstra, G.; Webb, C 2005
- Year:
- 2 005
- Bibliographic source:
- Health effects SIAR for Long Chain Alcohols (C6-22) including Iuclid dossiers chapter 5 prepared for the Aliphatic Alcohols category
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: contract laboratory protocol
- GLP compliance:
- no
- Test type:
- other: LD50
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C12-14
- EC Number:
- 279-420-3
- EC Name:
- Alcohols, C12-14
- Cas Number:
- 80206-82-2
- Molecular formula:
- C13H28O
- IUPAC Name:
- Alcohols, C12-14
- Details on test material:
- - Name of test material (as cited in study report):Alcohols, C12-14Type A. 100% Linear; >90% C12/14 (C12>14), <10% C16 [range C6-C18]; Even Type B. 100% Linear; >95% C12/14 (C12<14) [range C8-C18]; Even
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 to 3.1 kg
- Housing: Individual housing in metal cages which were elevated above the droppings.
- Diet: Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
IN-LIFE DATES: Not specified.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: applied undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Skin of the trunk.
- Type of wrap if used: Plastic binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test material was washed from the animals' bodies which were then carefully blotted dry with absorbent paper hand towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose 1-2 ml/kg, doses 1, 1.5 and 2 g/kg
VEHICLE
- Concentration (if solution): Applied undiluted. - Duration of exposure:
- 24 hours
- Doses:
- 1, 1.5 and 2 g/kg
- No. of animals per sex per dose:
- 2 male, 2 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed at the beginning and end of the study period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days. - Statistics:
- No statistical analysis of the results was carried out.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Low toxicity expected; LD50 > 2000
- Mortality:
- All deaths occurred within 3 days of exposure. Number of deaths at each dose: Intact skin 0/2, 1/2 and 2/2, abraded skin 0/2, 0/2 and 2/2. LD50(s) were as follows: Intact skin: 1.5 g/kg; Abraded skin: 1.5 - 2 g/kg; combined intact and abraded 1.5 - 2 g/kg.
- Clinical signs:
- other: At the dose of 1g/kg there were no signs of toxicity. At higher dose levels some prostration was noted. Survivors appeared normal 72 hours after exposure. Animals at all dose levels showed erythema, wrinkling and desquamation of the application site.
- Gross pathology:
- In premature decedents there was some general deterioration but no dose-related lesions. Tissues of survivors sacrificed at the end of the observation period were unremarkable.
- Other findings:
- No potential target organs were identified. The results were reported in combined form with no note on sex specific differences.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 of Alcohols, C12-14 was > 2000 mg/kg. All rabbits showed irritation of the application site immediately following exposure. Some prostration was observed in animals at the higher dose levels. Necropsy findings showed no treatment related lesions.
- Executive summary:
C12-14 alcohols are expected to be of low acute dermal toxicity LD50 >2000 mg/kg.
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