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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:
August 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
According to HLE protocol 543/1.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Aldbrough, Nr. Hull
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 18-20 h(overnight)
- Housing: single air-conditioned room; caged in groups of 5 by sex in suspended grid floor cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 10 %
- Photoperiod: natural lighting conditions

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 sex/dose
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 7 and 14 after treatment
- Necropsy of survivors performed: no
- Other examinations performed: clinical bobservations, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
No signs of overt toxicity.
Body weight:
Normal body weight gains.

Any other information on results incl. tables

Group mean body weights in g

dose level (mg/kg) no. of animal/sex group mean body weights
day before treatment day 7 day 14
2000 5 F 254 282 315
2000 5 M 224 247 261

All animals survived until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (rat) > 2000 mg/kg bw.
Executive summary:

Method

Acute toxicity study by oral route, carried out as limit test. A dose of 2000 mg/kg bw was adminstered by gavage to 5 rat/sex, using distilled water as vehicle; animals were observed up to 14 days after dosing.

Results

No deaths occurred, thus an LD50 > 2000 mg/kg was established. Body weight gains during the study period were normal.