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EC number: 911-739-1 | CAS number: 99402-80-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 01 APR 1980 to 15 APR 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: company guideline similar to OECD guideline 401
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 99402-80-9
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WISKf(SPF71), Hoechst AG, breeding colony
- Weight at study initiation: 172.4 g +/- 5.72 g
- Fasting period before study: 16 h
- Housing: grouped, plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 12.5 % - Doses:
- 10000 mg/kg bw (splitted in 2 applications within 1 h)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animals died within the observation period
- Mortality:
- - no deaths occurred
- Clinical signs:
- other: - 5-6 hours after application some clinical signs of toxicity (high legs) were observed - no clinical symptoms were observed in any animal 24 h or later after test item application - faeces was red-coloured
- Gross pathology:
- - animals killed at the end of the observation period showed no macroscopically visible changes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Single application of 10000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 10000 mg/kg bw.
- Executive summary:
Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 10000 mg/kg bw (12.5% suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >10000 mg/kg bw.
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