Registration Dossier
Registration Dossier
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EC number: 211-112-6 | CAS number: 629-82-3
Endpoint summary
Administrative data
Description of key information
acute oral toxicity (rat): LD50 > 2000 mg/kg bw (no mortality)
acute dermal toxicity (rat): LD50 > 2000 mg/kg bw (no mortality)
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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Cetiol OE
- Physical state: liquid
- Analytical purity: >99.9%
- Lot/batch No.: 7/91 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- no mortality
- Clinical signs:
- other: no effects
- Gross pathology:
- no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50>2000 mg/kg body weight
- Executive summary:
The acute oral toxicity of the test substance was investigated in young adult Wistar rats according to OECD guideline 401. The test article was dissolved in arachidis oil and given orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days, the rats were observed for any signs of reaction. The surviving rats were sacrified at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 was >2000 mg/kg for male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other:
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C-SAT 080029
- Physical state: liquid
- Analytical purity oder Active matter: 99.1%
- Lot/batch No.: CE72530027 - Species:
- rat
- Strain:
- other: CD/Crl:CD (SD)
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality was observed
- Mortality:
- none
- Clinical signs:
- other: no changes
- Gross pathology:
- no changes
- Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- substance not toxic after dermal application
- Executive summary:
The study was performed as a limit test according to OECD guideline 402. Wistar rats (5 males and 5 females) were randomly selected for the study. The group was exposed to a single dermal dose of 2000 mg/kg b.w. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two-week observation period the animals were killed and subjected to a gross necropsy examination. All animals survived the application and did not reveal any signs of toxicity. The animals gained the expected body weight. No skin reactions at the application site were observed. No macroscopic findings were observed at necropsy. These results indicate that the test substance has no significant toxic effect in the rat following dermal administration of a single dose at a level of 2000 mg/kg.
Reference
LD0>2000 mg/kg
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity:
The acute oral toxicity of the test substance was investigated in young adult Wistar rats according to OECD guideline 401. The test article was dissolved in arachidis oil and given orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days, the rats were observed for any signs of reaction. The surviving rats were sacrified at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 was >2000 mg/kg for male and female rats.
Based on the reliability and relevance, this study has been used as key study.
Acute dermal toxicity:
A study was performed as a limit test according to OECD guideline 402. Wistar rats (5 males and 5 females) were randomly selected for the study. The group was exposed to a single dermal dose of 2000 mg/kg b.w. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two-week observation period the animals were killed and subjected to a gross necropsy examination.All animals survived the application and did not reveal any signs of toxicity. The animals gained the expected body weight. No skin reactions at the application site were observed. No macroscopic findings were observed at necropsy.These results indicate that the test substance has no significant toxic effect in the rat following dermal administration of a single dose at a level of 2000 mg/kg.
Based on the reliability and relevance, this study has been used as key study.
Acute inhalation toxicity:
Inhalation toxicity has not been evaluated as the predominant exposure route is via the dermal route.
Justification for classification or non-classification
Based on results of the key studies the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).
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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