Registration Dossier
Registration Dossier
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EC number: 482-130-1 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test animals
- Species:
- other: Rat, (Sprague-Dawley)
Administration / exposure
- Vehicle:
- other: The test material was used as supplied.
- No. of animals per sex per dose:
- Preliminary sighting study: 1 (female)
Main study: 5 (female) - Details on study design:
- Preliminary sighting study:
At the request of the sponsor, 5000 mg/kg was chosen as the
starting dose.
Main study:
In the absence of toxicity at a dose level of 5000 mg/kg, an
additional group of animals was treated at the same dose
level.
Results and discussion
- Preliminary study:
- Species/strain: Rat, (Sprague-Dawley)
5000 mg/kg bw: Evident toxicity: N; Mortality: N
Observations:
Mortality:
There were no deaths.
Clinical observations:
No signs of systemic toxicity were noted.
Bodyweight:
The animal showed expected gain in bodyweight over the
study period.
Necropsy:
No abnormalities were noted at necropsy.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Dose descriptor:
- other: 5000 mg/kg bw (fixed dose initial)
- Remarks on result:
- other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5
- Clinical signs:
- other: Signs of toxicity: Mortality: There were no deaths.
- Gross pathology:
- Effects on organs:
Necropsy:
No abnormalities were noted at necropsy. - Other findings:
- Clinical observations:
No signs of systemic toxicity were noted.
Bodyweight:
All animals showed expected gains in bodyweight over the
study period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
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