Registration Dossier
Registration Dossier
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EC number: 617-350-0 | CAS number: 82543-18-8
Endpoint summary
Administrative data
Description of key information
Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Nihon Schering K.K., Report No. A06867, 2004-06-18]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Nihon Schering K.K., Report No. A06723, 2004-06-18]
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August to October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996-03-22
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Doses:
- 200 and 2000 mg/kg (application volume 2 ml/100 g)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The single oral administration of the test substance (ZK 92836) to male and female rats at doses of 200 and 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Dimethylenpropanol in rats is therefore above 2000 mg/kg body weight.
Reference
No animals died in the course of the study. No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September to October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- yes
- Remarks:
- 3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The single dermal administration of the test substance (ZK 92836) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenpropanol in rats is therefore above 2000 mg/kg body weight.
No local intolerance reactions at the application sites were observed.
Reference
No animals died in the course of the study. No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
No local intolerance reactions at the application sites were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The single oral administration of the test substance (ZK 92836) to male and female rats at doses of 200 and 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Dimethylenpropanol in rats is above 2000 mg/kg body weight.
The single dermal administration of the test substance (ZK 92836) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenpropanol in rats is above 2000 mg/kg body weight.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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