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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
Reference
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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.