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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 31 OCT 1988 to 14 NOV 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation: males mean: 195 g; females mean: 180 g
- Fasting period before study: approx. 16 h
- Housing: fully air-conditioned rooms in Makrolon cages (Type 4) in groups of 5
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3%
- Humidity (%): 50+-20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% w/v

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
limit dose: 2000 mg/kg bw
No. of animals per sex per dose:
5
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, body weight,organ weights, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animals died within the observation period
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animals died within the observation period
Mortality:
- no deaths occured
Clinical signs:
- no signs of toxicity were observed
- faeces and litter were yellow-coloured in all animals on day 1 and 2 post application
Body weight:
- body weight development was not impaired
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: other: CLP regulation
Conclusions:
Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

Male and female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the limit dose of 2000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.