Registration Dossier
Registration Dossier
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EC number: 424-090-1 | CAS number: 10097-02-6 DMBA
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.3
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-bis(hydroxymethyl)butanoic acid
- EC Number:
- 424-090-1
- EC Name:
- 2,2-bis(hydroxymethyl)butanoic acid
- Cas Number:
- 10097-02-6
- Molecular formula:
- C6H12O4
- IUPAC Name:
- 2,2-bis(hydroxymethyl)butanoic acid
- Details on test material:
- supplier: study sponsor
sample batch:5J01
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (SPF)
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Bidestilliertes Wasser "ENGLISH" bidist. water
- Duration of exposure:
- 24 hours
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- 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: no mortalities occurred. No clinical symptoms were observed.
- Gross pathology:
- Effects on organs:
No effects to the organs were observed. - Other findings:
- Signs of toxicity (local):
Slight scaling of the treated skin was observed in one male and two females, which persisted in two animals (one female and one male) until day 11 and in one female animal until day 12 of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as dangerous for dermal acute toxicity according to Regulation (EC) No 1272/2008 (CLP Regulation)
- Conclusions:
- No adverse effect was observed.
- Executive summary:
The test of acute dermal toxicity to the rat (strain Wistar) for DMBA was performed as a limit test according to 92/69/EWG, B.3 (OECD 402) under GLP condition. 5 females and 5 males of rats were exposed with semiocclusive type of coverage to dose of 2000 mg/kg bw for 24 hours.
Results: No mortalities occurred and no clinical symptoms were observed. The body weight gain was within the range commonly recorded for animals of this strain and age.
No effects to the organs were observed. Only slight scaling of the treated skin was observed in one male and two females, which persisted in two animals (one female and one male) until day 11 and in one female animal until day 12 of the observation period.
The LD50 was established as more than 2000 mg/kg bw. (LD 50 > 2000 mg/kg bw).
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