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Toxicological information

Acute Toxicity: oral

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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:
1980
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

Constituent 1
Reference substance name:
Reference substance 002
Cas Number:
99402-80-9
Test material form:
solid: nanoform, no surface treatment

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.