Registration Dossier
Registration Dossier
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EC number: 473-100-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 2004/73/EG, B.1tris (Akute-toxische-Klassen-Methode); OECD 423 (2001)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- other: rat, Wistar Crl:WI BR (SPF)
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 2000 mg/kg BW; 300 mg/kg BW; 300 mg/kg BW
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 1
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
The decedents were found between Days 1 and 2 post-
treatment.
Clinical signs observed during the study period were as
follows:
2000 mg/kg: Lethargy, hunched posture, laboured
respiration, piloerection and ptosis.
300 mg/kg : Lethargy, hunched posture, uncoordinated
movements, piloerection and ptosis.
The surviving animals had recovered from the symptoms
between Days 2 and 3. - Gross pathology:
- Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the OECD 423 test guideline, the LD50 cut-off was considered to be 500 mg/kg body weight.
The Test substance should be labelled as: harmful if swallowed (R22)
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