Registration Dossier
Registration Dossier
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EC number: 243-718-1 | CAS number: 20298-69-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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:
- yes
Test material
- Reference substance name:
- cis-2-tert-butylcyclohexyl acetate
- EC Number:
- 243-718-1
- EC Name:
- cis-2-tert-butylcyclohexyl acetate
- Cas Number:
- 20298-69-5
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 2-tert-butylcyclohexyl acetate
- Test material form:
- liquid
- Details on test material:
- Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- No data.
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 10/dose; sex unknown
- Control animals:
- no
- Details on study design:
- - Necropsy of survivors performed: not clear from report
- Other examinations performed: skin irritation (time/frequency of observations not reported)
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Diarrhea was observed in 1 animal.
- Other findings:
- Skin irritation: Slight redness in 6 animals, moderate redness in 4 animals; slight edema in 3 animals, moderate edema in 7 animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not acute harmful
- Remarks:
- in accordance with EU CLP (1272/2008 and its updates)
- Conclusions:
- A LD50 > 5000 mg/kg bw was established in an acute dermal toxicity study with rabbits.
- Executive summary:
In an acute dermal toxicity study with rabbits, similar to OECD TG 402 but non-GLP, the LD50 was greater than 5000 mg/kg bw. A group of 10 animals (strain, sex and age unspecified) received a single application of 5000 mg/kg bw test substance. There were no deaths. Diarrhea was observed in one animal. Skin irritation findings included erythema (slight in 6 animals, moderate in 4 animals) and edema (slight in 3 animals, moderate in 7 animals).
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