Registration Dossier
Registration Dossier
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EC number: 203-328-4 | CAS number: 105-76-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to the OECD guideline 402
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dibutyl maleate
- EC Number:
- 203-328-4
- EC Name:
- Dibutyl maleate
- Cas Number:
- 105-76-0
- Molecular formula:
- C12H20O4
- IUPAC Name:
- dibutyl but-2-enedioate
- Details on test material:
- Dibutyl maleinat, dibutylmaleate, K Nr.: 215 7135
Supplier: Chemie Linz GnbH
Purity and impurities: unknown
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source - Commercial supplier - Sprague-Dawley (Him:OFA)
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Pure compound was applied on at least 10% of the body surface on the hair-clopped area.
- Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- not specified
- Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no data on confidence limits
- Mortality:
- All animals survided the test.
- Clinical signs:
- other: No behavioral observations were recorded. Medium grade erythema was observed one or two days p.a. in all males and three females.
- Gross pathology:
- Microscopic observations did not show other lesions.
- Other findings:
- Chromodacryorrhea was observed in four males and five females between the begining of the test and 6 hours p.a.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LC50 > 2000 mg/kg.
- Executive summary:
The potential toxic effects of DBM was assessed according to the OECD guideline 402 for acute dermal toxicity in Sprague-Dawley (Him:OFA) rats. Observations included medium grade erythema in all males and in three females and chromodacryorrhoea in four males and five females within six hour p.a.. All animals survided the test. During macoscopic examination at necropsy, no lesions were observed.
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