Registration Dossier
Registration Dossier
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EC number: 619-799-8 | CAS number: 66309-83-9
Endpoint summary
Administrative data
Description of key information
Oral (Rat, according to OECD TG 423): LD50 >2000 mg/kg
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:
- Oct -Nov 2005
- 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:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Purity: 95.3%
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- other: tap water with the aid of 2% Cremophor EL
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals, two replicates
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A dose of 2000 mg/kg body weight was tolerated by female rats without mortalities.
- Clinical signs:
- other: The clinical signs were decreased motility, uncoordinated gait and reactivity decreased.
- Gross pathology:
- A dose of 2000 mg/kg body weight was tolerated by female rats without gross pathological findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has not to be classified for acute oral toxicity.
- Executive summary:
A dose of 2000 mg/kg body weight was tolerated by female rats without mortalities, effects on weight gain and gross pathological findings.
The clinical signs were decreased motility, uncoordinated gait and reactivity decreased.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score 1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the study results no classification for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) is required.
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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