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Description of key information

The test substance is of low oral acute toxicity with an oral LD50 ( rat) of > 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:
2004-05-20 to 2004-07-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: 
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Strain: Sprague-Dawley CD (Crl: CD® (SD) IGS BR)
- approx. 12 weeks
- body weight: 203 - 245 g
- Fasting period before study: overnight
- Diet: ad libitum, (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK)
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 19 to 25° C
- Humidity (%): 30 to 70 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: at least 15 change per hour
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose: 300 and 2000 mg/kg/bw
- DOSAGE PREPARATION: the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP.
The administration volume was 10 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 3000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 6 female rats are treated with 2000 mg/kg b.w.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
3 female, 300 mg/kg/bw
6 female, 2000 mg/kg/bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for deaths or overt signs of toxicity 0,5, 1, 2 and 4 hours after dosing
and subsequently once daily for fourteen days.
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: At the end of the observation period the animals were killed by cervical dislocation.
All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
not required
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were found at necropsy.
Other findings:
no other findings

see attached document

Conclusions:
The test substance is non toxic if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001)

A group of three fasted females was treated with the test material at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females (2 x 3 females) were treated at a dose level of 2000 mg/kg bodyweight. Dosing was performed sequentially.

No animal died prematurely.

All animals gained the expected body weight.

No pathological changes were observed at necropsy.

Therefore, the test substance is non toxic if swallowed, as LD50 > 2000 mg/kg b.w., p.o.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study is valid without restriction (Klimisch 1).

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

Based on the results of the acute oral study and according to the criteria of EC Regulation 1272/2008 the test item has a low acute toxicity if swallowed (LD50 (rat) > 2000 mg/kg bw). Therefore, the test substance must not be classified.