Registration Dossier
Registration Dossier
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EC number: 422-630-9 | CAS number: 22208-25-9
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 422-630-9
- EC Name:
- -
- Cas Number:
- 22208-25-9
- Molecular formula:
- C18H26O9
- IUPAC Name:
- 2,2-bis({[(3-oxobutanoyl)oxy]methyl})butyl 3-oxobutanoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) BR
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: No vehicle was used. The test substance was dosed undiluted.
- Duration of exposure:
- 24 h
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The animals showed expected body weight gain during the study
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination
- Other findings:
- Signs of toxicity (local):
Erythema, scales and scabs in the treated skin-area and red staining in the neck were seen among several animals during the observation period.
The animals had recovered from the symptoms between days 5 and 8, except for red staining in the neck of one female which persisted until termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 in rats was determined to be higher than 2000 mg/kg bw.
- Executive summary:
The study was conducted according to EU Method B.3 (GLP study). Wistar Crl:(WI) BR male and female rats were treated with the substance at 2000 mg/kg bw (limit test). Due to the absence of mortality, relevant clinical signs and abnormalities in the organs, the dermal LD50 was determined to be higher than 2000 mg/kg bw.
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