Registration Dossier
Registration Dossier
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EC number: 201-222-2 | CAS number: 79-74-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is not performed under GLP conditions, used methods and results are preliminary documented.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were administered 1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A in corn oil as single oral dose and were observed for 14 days.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Santovar A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no information provided
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Doses:
- 1260, 1580, 2000, 2510, 3160 mg/kg bw Santovar A
- No. of animals per sex per dose:
- 3 or 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 900 mg/kg bw
- 95% CL:
- > 1 800 - < 2 000
- Mortality:
- Yes
- Clinical signs:
- other: Reduced appetite and activity, increasing weakness, collapse, and death.
- Gross pathology:
- Hemorrahagic areas of the lungs, slight liver hyperemia, and acute gastrointestinal inflammation.
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- A study in rats suggested that Santovar was slightly toxic, an oral LD50 of 1900 mg/kg bw was reported. The study was not performed according to the general guidelines for acute oral toxicity under GLP conditions and was very poorly documented. Therefore, the information may be considered reliable with major restrictions.
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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