Registration Dossier
Registration Dossier
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EC number: 425-000-1 | CAS number: 61718-80-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- 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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methylcellulose 0,5 % w/v
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/males/2000 mg/kg
5/females/2000 mg/kg - Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Males: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Females: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
No deaths occurred in the treated animals of either sex.
No clinical abnormalities were observed in treated animals during the observation period. - Body weight:
- A slight decrease of body weight or growth was found in some females treated at 2000 mg/kg only at the day 3 weighing.
Normal body weight growth was seen in the treated males. - Gross pathology:
- Effects on organs:
At the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute oral toxicity.
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