Registration Dossier
Registration Dossier
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EC number: 229-755-6 | CAS number: 6707-60-4
Endpoint summary
Administrative data
Description of key information
The experimental rat LD50 dosed via the oral route was >5000 mg/kg (Klimisch 4).
The experimental rat LD50 dosed via the oral route was >2000 and <8000 mg/kg (Klimisch 4).
Therefore, even though the experimental data are on Klimisch 4, the consistant volue confirms the low oral toxicity of Cervolide and the lack of classification.
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:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Testing was performed before OECD guideline published.
- GLP compliance:
- no
- Specific details on test material used for the study:
- name of testing material: 77-227 Hibiscolide
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Preliminary study:
- Acute oral toxicity in rates
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 10 rats were used in the study. The animals were observed over a 14 day period for mortality and/or systemic effects. A gross necropsy was conducted on all animals.
The oral LD50 of 12-oxahexadecanolide in rats exceeded 5000 mg/kg with 0/10 deaths at that dose - Executive summary:
The oral LD50 of 12-oxahexadecanolide in rats exceeded 5000 mg/kg with 0/10 deaths at that dose.
Cevolide does not met the criteria for classication according the CLP Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Justification for classification or non-classification
The experimental rat LD50 dosed via the oral route was >5000 mg/kg (Klimisch 4).
The experimental rat LD50 dosed via the oral route was >2000 and <8000 mg/kg (Klimisch 4).
The consistant volue confirms the LD50 of Cervolide is more than 2000 mg/L.Therefore,
Cetonal does not met the criteria for classication according the CLP Regulation (EC) No. 1272/2008.
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