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Administrative data

Description of key information

The acute oral toxicity of the registered substance was evaluated in accordance with OECD Testing Guideline 420. There were no deaths at up to 2.000 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:
April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 164 g. Body weight variation did not exceed +/- 20% of the body weight of the initially dosed animals.
- Fasting period before study: Overnight fast immediately before dosing and approximately three to four hours after dosing.
- Housing: suspended solid floor polypropylene cages furnished with wood chippings.
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): Fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light and twelve hours darkness.
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Arachis oil was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED:
2,000 mg/kg
Doses:
In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
In the absence of toxicity at the dose level of 300 mg/kg, an additional dose level of 2,000 mg/kg was included.
No. of animals per sex per dose:
300 mg/kg - 1 animal
2,000 mg/kg - 5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 1/2, 1, 2 and 4 hours after dosing, and then daily for fourteen days. Individual body weights were recorded on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: external examination, opening abominal and thoracic cavities.
Preliminary study:
There was no mortality; no signs of systemic toxicity were noted during the observation period.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted during the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test material in female Wistar strain rat was estimated to be greater than 2,000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.


Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.


There were no deaths.
There were no signs of systemic toxicity.
All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.


The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Testing was GLP-compliant and conducted according to a relevant OECD Guideline.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
1

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral route
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths.
There were no signs of systemic toxicity.
All animals showed expected gains in body weight.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

Justification for classification or non-classification

Testing was conducted on the registered substance in accordance with REACH, which concluded that it did not meet the criteria for classification according to Regulation (EC) No 1272/2008.