Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible
ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.
The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food. The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
For the purpose of the study the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in arachis oil BP. For the purpose of the 2000 mg/kg dose level the test item was used as supplied
Details on oral exposure:
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 a dose level of 300 mg/kg, an additional animal was treated at 2000 mg/kg.
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of 4 animals was treated at 2000 mg/kg.
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
1 in the 300 mg/kg dose
5 n the 2000 mg/kg dose
Control animals:
not specified

Results and discussion

Preliminary study:
A sighting test has been conducted at dose levels of 300 mg/kg and 2000 mg/kg.
Effect levels
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:
Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were ataxia, hunched posture and lethargy. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg.
Body weight:
Animals showed expected gains in body weight except for one animal treated at a dose level of 2000 mg/kg which showed body weight loss during the first week with expected gain in body weight during the second week.
Gross pathology:
Abnormalities noted at necropsy of one animal treated at a dose level of 2000 mg/kg were ulcerated gastric mucosa, stomach adhered to the wall of the abdomen and thickened non-glandular epithelium of the stomach. No abnormalities were noted at necropsy
of the remaining animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LDso) 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 - Category 5).