Registration Dossier
Registration Dossier
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EC number: 619-300-3 | CAS number: 97928-19-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 21 rats (10 males, 11 females). Weight/rat: 68-96 g. Age: 4 weeks aprox.
Upon arrival at the Lab, they were housed in Makrolon cages (55x32.7x19cm) with a chip bed, up to a maximum of 5 rats of the same sex per cage and were subjected to a period of prior observation and acclimatization not less than a week.
The animal involved in the preliminary study weighed 109g at the beginning of it.
The rats treated in the main study weighed 102-124g at the time of administration.
The temperature and relative humidity in the lab were maintained at 20-24ºC and 60-80% respectively, reaching points of 52-59% and 8185% relative humidity.
The photoperiod was controlled to provide 12 hours of light (7.00-19.00h) and 12 hours of darkness every 24h.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 10 mL/kg
- No. of animals per sex per dose:
- 21 rats (10 males, 11 females)
- Control animals:
- yes
Results and discussion
- Preliminary study:
- See full report
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Substance is not classified as a toxic substance.
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