Registration Dossier
Registration Dossier
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EC number: 701-388-0 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2nd October 1986 to 16th October 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- EC Number:
- 701-388-0
- Cas Number:
- 26850-24-8
- IUPAC Name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- Test material form:
- other: pale yellow solid block
- Details on test material:
- - Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- not specified
- Details on study design:
- The animals were examined daily for signs of toxicity for 15 consecutive days.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test material is estimated to be >2g/kg bw based on no mortality, no signs of toxicity or any treatment-related body weight effects.
- Executive summary:
In an acute toxicity study the substance was administered to New Zealand White rabbits (5 animals/sex/dose) by dermal application at a dose level of 5 g/kg bw (single administration). The animals were examined daily for 15 days post dosing. There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is 5g/kg bw.
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