Registration Dossier
Registration Dossier
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EC number: 937-760-6 | CAS number: 1225478-65-8
Endpoint summary
Administrative data
Description of key information
The oral LD50 value determined in the rat was between 300 and 2000 mg/kg bw (read across, CAS 752984-24-0).
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:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according EU/OECD guideline.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 300 and 2000 mg/kg body weight (bw)
- No. of animals per sex per dose:
- 3 female rats
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals dosed with 2000 mg/kg bw died during the observation period.
- Clinical signs:
- other: Clinical cramps, tremor, labored breathing, lateral position and gasping.
- Gross pathology:
- The necropsy did not reveal any treatment-related findings.
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
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
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes. As a result the substance need to be classified and labelled as acute oral category 4 under Regulation (EC) No 1272/2008.
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