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EC number: 225-306-3 | CAS number: 4767-03-7
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 June 2007 to 19 June 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-bis(hydroxymethyl)propionic acid
- EC Number:
- 225-306-3
- EC Name:
- 2,2-bis(hydroxymethyl)propionic acid
- Cas Number:
- 4767-03-7
- Molecular formula:
- C5H10O4
- IUPAC Name:
- 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material used in the study report: Dimethylolpropionic acid
- Batch no.: not given
- Purity: not given
- Appearance: not given
- Expiry date: not given
- Storage conditions: not given
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were male and female Wistar SPF rats, obtained from Velaz Prague. Both males and females weighed 180-220 g. They were acclimatised for 7 days, during which time the health status of the rats was monitored continuously. On arrival, group of three rats were placed in one cage (same sex groups). Surplus animals were discarded from those with outlying body weight. They were housed in Type T-4 cages (Velaz, Prague), cage racks and other equipment were sanitised twice a week. Potable mains tap water was supplied via glass bottles with stainless steel sipper tubes. Standard diet KKZ-P/M (ÚEF SAV, Dobrá Voda) was supplied ad libitum.
The study was carried out under SPF conditions. The temperature and relative humidity of the animal rooms were maintained at 22±2°C and 30-70%. The animals were subjected to a 12 hour light: 12 hour dark cycle.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- olive oil
- Details on dermal exposure:
- The study was carried out according to OECD guideline 402, no further information is available in the report.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats/sex
- Control animals:
- no
- Details on study design:
- The study followed OECD guideline 402. Rats with outlying body weights were not used in the study. A single limit dose of 2000 mg/kg bw dimethylolpropionic acid in olive oil was applied dermally to 5 male and 5 female rats. Rats were observed for 2 weeks; body weights were recorded on Day 1, 7 and 15.
- Statistics:
- Not applicable.
Results and discussion
- Preliminary study:
- No information available.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed in the study
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Not reported
- Gross pathology:
- Necropsies were not reported
- Other findings:
- None reported.
Any other information on results incl. tables
Table 1: Body weight changes.
| Female Body Weights (g) | Male Body Weights (g) | ||||||||
Animal No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Day 1 | 180 | 185 | 185 | 180 | 180 | 195 | 200 | 200 | 195 | 205 |
Day 7 | 185 | 195 | 190 | 185 | 185 | 210 | 205 | 205 | 200 | 210 |
Day 15 | 190 | 200 | 195 | 190 | 195 | 215 | 215 | 210 | 210 | 215 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of dimethylolpropionic acid in Wistar rats is > 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (conducted according to OECD TG 402), groups of 5 male and 5 female Wistar rats were dermally exposed to Dimethylolpropionic acid in olive oil for at the limit dose of 2000 mg/kg bw. Animals were then observed for 2 weeks. No deaths occurred at the limit dose during this 2 week observation period. There were no treatment related changes in body weight. The acute dermal LD50 of dimethylolpropionic acid is > 2000 mg/kg bw.
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