Registration Dossier
Registration Dossier
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EC number: 200-838-9 | CAS number: 75-09-2
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: Although application area was rather small, this was not considered to have significantly influenced the outcome of the study; OECD Guideline 402 and GLP-compliant study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dichloromethane
- EC Number:
- 200-838-9
- EC Name:
- Dichloromethane
- Cas Number:
- 75-09-2
- Molecular formula:
- CH2Cl2
- IUPAC Name:
- dichloromethane
- Details on test material:
- Dichloromethane (Production: TA, June 1985), a volatile colourless liquid. The test material was supplied by Solvay and Cie, Bruxelles, Belgium.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- SPF-derived males (180-200 g) and femals (160-180 g) at arrival.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- applicaton surface was 15 cm2
- Duration of exposure:
- 24 hours, 14 days observation period
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- For ethical reasons the control group was used for a number of studies which were carried out in parallel. The data of this group are filed under study no. DT 88/17.
Investigated parameters: clinical signs, body weights and body weight gains, autopsy and organ weights. - Statistics:
- The results were evalulated with an analysis of variance followd by a Student t-test (two-sided).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Mortality was not observed.
- Clinical signs:
- other: Vocalization was observed in the first half an hour of treatment in all males and 2 females. All males of the treated group and one female of the control group were a little bit quiet. At 1 .5 hours after application period signs had disappeared.
- Gross pathology:
- 4 males and 4 females showed swollen or slightly swollen livers (compared with 1 male and 1 female in the controls).
Absolute and relative liver weights of the males were statistically significantly decreased. - Other findings:
- No effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/ktg bw.
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