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Description of key information

Acute oral toxicity in rats: LD50 > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be greater than 2000 mg/kg bw, therefore the test substance is above the classification threshold for acute oral toxicity (Category 4: 300 < ATE ≤ 2000 mg/kg).