Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 October 2017 to 26 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 Nousan No. 8147, 24 November 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
CAS number: Not yet known
EC Number: Not yet known
Specific details on test material used for the study:
Purity: >93%
Physical State/Appearance: Dark amber viscous liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
A sighting test using one animal, and additional four animals
Control animals:
no
Details on study design:
Following a sighting test at a dose level of 2000 mg/kg body weight in one fasted female animal, an additional four fasted female animals were given a single oral dose of the undiluted test item at a dose level of 2000 mg/kg body weight and followed with a 14-day observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no unscheduled deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
Based on historical data from the supplier for this strain, all animals showed expected gains in body weight over the observation period, except for one animal which showed an expected gain in body weight during the first week of the study but a slight body weight loss (-2.5%) during the second week.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
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.
Executive summary:

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

Following a sighting test at a dose level of 2000 mg/kg body weight in one fasted female animal, an additional four fasted female animals were given a single oral dose of the undiluted test item at a dose level of 2000 mg/kg body weight and followed with a 14-day observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no unscheduled deaths and no signs of systemic toxicity. Based on historical data from the supplier for this strain, all animals showed expected gains in body weight over the observation period, except for one animal which showed an expected gain in body weight during the first week of the study but a slight body weight loss (-2.5%) during the second week. 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.