Registration Dossier
Registration Dossier
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EC number: 932-235-8 | CAS number: -
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: The study was conducted according to a protocol which is comparable to guideline but it was not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The undiluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, in tact skin of male/female rabbits.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Undecan-1-ol
- EC Number:
- 203-970-5
- EC Name:
- Undecan-1-ol
- Cas Number:
- 112-42-5
- IUPAC Name:
- undecan-1-ol
- Details on test material:
- No detail available.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 1.8-2.5kg
- Housing: individual cages
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- Test material was applied to intact skin.
- Duration of exposure:
- 24 hours
- Doses:
- 3160, 5010 and 7940 mg/kg
- No. of animals per sex per dose:
- 3160 mg/kg; 1F, 5010mg/kg; 1M, 7940 mg/kg;1M, 1F.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 010 - < 7 940 mg/kg bw
- Mortality:
- A female rabbit died at 7940mg/kg dose level on day 4.
- Clinical signs:
- other: Reduced appetite and activity and lethargy (three to five days in survivors), increasing weakness, collapse and death.
- Gross pathology:
- At necropsy there was slight lung congestion, liver discolouration, enlarged gall bladder and slight gastrointestinal inflammation. Surviving animals were sacrificed 14 days after dosing. The viscera appeared normal by macroscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The rabbit acute dermal LD50 was reported to be > 5010 mg/kg (but <7940 mg/kg). The study was not compliant with GLP.
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