Registration Dossier
Registration Dossier
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EC number: 203-972-6 | CAS number: 112-44-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 961
- Report date:
- 1961
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Final Order, Enforcement Regulations (Fed. Register of August 12, 1961, Vol 26, No. 155, pages 7333-7341)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Undecanal
- EC Number:
- 203-972-6
- EC Name:
- Undecanal
- Cas Number:
- 112-44-7
- Molecular formula:
- C11H22O
- IUPAC Name:
- undecanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): EOA 71-15, Aldehyde C-11 Undecyl
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2500 to 3500 g
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10.7% of body surface
- Type of wrap if used: made of rubber dam
REMOVAL OF TEST SUBSTANCE
- Washing: after removal of sleeves by thorough wiping
- Time after start of exposure: up to 24 h - Duration of exposure:
- up to 24 h
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 6 (3 animals with intact skin, 3 animals with abraded skin)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no animals died within the 14 days observation period
- Mortality:
- no deaths occurred
- Clinical signs:
- other: dry and cracked skin noted
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the tested conditions, the substance did not reveal acute dermal toxicity, no animal died after single dermal application of 5000 mg/kg bw.
- Executive summary:
The test item (purity: not stated) was subjected to test acute dermal toxicity in albino rabbits. This study was conducted according to the requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at a limit dose of 5000 mg/kg bw onto the intact or abraded skin of the animals (3 animals per condition) for up to 24 h under occlusive conditions. During the 14 days observation period dry and cracked skin could be noted, but no animal died. The given results lead to a LD50 > 5000 mg test item per kg bw (Shelanski and Moldovan, 1971).
This study was judged to be reliable with restrictions (RL2), due to missing information on substance purity and the missing necropsy data.
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