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EC number: 203-208-1 | CAS number: 104-50-7
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401)
Acute dermal toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 402)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Route of administration:
- oral: unspecified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortalities were observed.
- Clinical signs:
- Lethargy was observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats, the LD50 of was >5000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (1778), 10 rats were given octan-4-olide at doses of 5000 mg/kg bw.
No mortalities were observed and lethargy was noted.
The LD50 was > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- There is 1 study available and it has a Klimisch score of 2. The quality of the database is medium.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rabbit
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortalities were obesrved.
- Clinical signs:
- Diarrhea was observed in 2/10 rabbits.
- Other findings:
- Skin irritation:
Slight redness was observed in 4/10 rabbits.
Moderate redness was observed in 5/10 rabbits
Slight edema was observed in 3/10 rabbits
Moderate edema was observed in 5/10 rabbits. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicitiy study in rabbits, the LD50 for octan-4-olide was >5000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (1778), 10 rabbits were given octan-4-olide at doses of 5000 mg/kg bw.
No mortalities were observed and diarrhea was observed in 2/10 rabbits. Slight redness was observed in 4/10 rabbits and moderate redness was observed in 5/10 rabbits. Slight edema was observed in 3/10 rabbits and moderate edema was observed in 5/10 rabbits.
The LD50 was > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- There is 1 study available and it has a Klimisch score of 2. The quality of the database is medium.
Additional information
Acute oral toxicity
There is one acute oral toxicity studies in rats available.
In an acute oral toxicity study (equivalent or similar to OECD 401), 10 rats were given octan-4-olide at doses of 5000 mg/kg bw. No mortalities were observed and lethargy was noted. The LD50 was > 5000 mg/kg bw.
Acute dermal toxicity
There is one acute dermal toxicity studies in rabbits available.
In an acute dermal toxicity study (equivalent or similar to OECD 402), 10 rabbits were given octan-4-olide at doses of 5000 mg/kg bw. No mortalities were observed and diarrhea was observed in 2/10 rabbits. Slight redness was observed in 4/10 rabbits and moderate redness was observed in 5/10 rabbits. Slight edema was observed in 3/10 rabbits and moderate edema was observed in 5/10 rabbits. The LD50 was > 5000 mg/kg bw.
The results from these studies are acceptable to use in the human health risk assessment.
Justification for classification or non-classification
Based on the available information in the dossier, the substance octan-4-olide (CAS No. 104-50-7) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure, when the criteria outlined in Annex I of 1272/2008/EC are applied.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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