Registration Dossier
Registration Dossier
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EC number: 210-848-5 | CAS number: 624-48-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Range-Finding Toxicity Data: List VI
- Author:
- Smyth HF et al.
- Year:
- 1 962
- Bibliographic source:
- American Industrial Hygiene Association Journal. Vol. 23, pp 95-107, 1962.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Deviations:
- not specified
- Principles of method if other than guideline:
- method as in to the one-day cuff method of Draize 1944 (Methods of study for irritation and toxicity of substances applied topically to the skin and mucous membranes, Journal Pharmacol. Exp. Therap. 82:377).
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Dimethyl maleate
- EC Number:
- 210-848-5
- EC Name:
- Dimethyl maleate
- Cas Number:
- 624-48-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- dimethyl (Z)-but-2-enedioate
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- body weight: 2.5 - 3.5 kg
Administration / exposure
- Details on dermal exposure:
- - fur removed from the entire trunk by clipping
- dose retained beneath an impervious plastic film
- immobilisation of the animals during exposure
- observation for 14 days after the end of exposure - Duration of exposure:
- 24 hours
- Doses:
- no data
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- no data
- Statistics:
- LD50: method of Thompson and Weil
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 0.53 mL/kg bw
- Based on:
- test mat.
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50,dermal,rabbit was 0.53 mL per kg body weight when applied for 24 hours to the intact skin of rabbits.
- Executive summary:
The test substance was applied to the intact skin of 4 male rabbits per group for 24 hours. The animals were observed for mortalities for further 14 days. The LD50, calculated according to the method of Thompson and Weil, was 0.53 mL per kg body weight.
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