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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 5 APR 1979 to 19 APR 1979
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: no individual data included in report
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house breeding (Hoe WISKf (SPF71))
- Weight at study initiation: 160 to 176 g
- Fasting period before study: 16 hours
- Housing: in plastic cages in groups
- Diet: Altromin 1324 (Altromin GmbH, Lage/lippe, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: starch mucilage (2%)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 12.5% suspension in 2% starch mucilage
Doses:
10000 mg/kg bw
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
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: no animals died within the 14 days observation period
Mortality:
- no deaths occured
Clinical signs:
- dye was excreted in the faeces
- no other clinical signs observed
Body weight:
- body weight development was not impaired
Gross pathology:
- in the animals sacrificed at the end of the observation period no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP Regulation
Conclusions:
Single application of the limit dose of 10000 mg test item per kg bw did not cause lethality in female rats during the 14 days observation period, resulting in a LD50 > 10000 mg/kg bw.
Executive summary:

Female Wistar rats were subjected to test acute oral toxicity. The test item was administered at the limit dose of 10000 mg/kg bw to ten rats. During the 14 days observation period no animals died and there were no changes found in necropsy, thus leading to a median lethal dose (LD50) > 10000 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.