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Description of key information

Acute oral toxicity

The acute oral median lethal dose (LD50) of the test material in the Sprague­ Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

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:
28 June 2000 to 19 July 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 226 - 241 g (males); 204 - 221 g (females)
- Fasting period before study: yes. Animals were fasted overnight immediately before dosing and for approximately three to four hours after dosing
- Housing: animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 30 - 70 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing

DOSAGE PREPARATION
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 or suspend in distilled water. Preparation was aided by the use of a vortex mixer and homogeneity was assured by the use of a Silverson Homogeniser.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily thereafter. Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes. 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.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed an expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of the study, the acute oral median lethal dose (LD50) of the test material in the Sprague­ Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris, under GLP conditions.

During the study a group of three fasted females was treated with the starting dose. This was followed by a group of three fasted animals of the other sex at the same dose level. Dosing was performed sequentially. Sufficient time was allowed between each sex to confirm the survival of the previously dosed animals.

The test material was administered orally as a suspension in arachis oil BP. The animals were observed 1/2, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14.  At the end of the observation period all animals were killed by cervical dislocation and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, there were no signs of systemic toxicity and all animals showed an expected gain in bodyweight. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the Sprague­ Dawley CD strain rat was therefore estimated to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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

Acute oral toxicity

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

During the study a group of three fasted females was treated with the starting dose. This was followed by a group of three fasted animals of the other sex at the same dose level. Dosing was performed sequentially. Sufficient time was allowed between each sex to confirm the survival of the previously dosed animals.

The test material was administered orally as a suspension in arachis oil BP.  The animals were observed 1/2, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14.  At the end of the observation period all animals were killed by cervical dislocation and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, there were no signs of systemic toxicity and all animals showed an expected gain in bodyweight. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the Sprague­ Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral route.