Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 February 2018 - 20 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 2008
Deviations:
no
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Appearance: White to pale yellow green powder
Batch: 171116
Test item storage: At room temperature protected from light
Stable under storage conditions until: 16 November 2019 (expiry date)

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
6 Females (nulliparous and non-pregnant).
Young adult animals (approximately 9-10 weeks old).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for general health/mortality and moribundity twice daily; postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter; weighed individually on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes/no
- Other examinations performed: subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Hunched posture, piloerection, uncoordinated movements, pale skin and/or pale appearance were noted for the animals between Days 1 and 13.
Body weight:
Body weight loss was noted for three animals on Day 8; these animals regained weight during the second week. The body weight gain shown by the other three animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

The potential toxicity of the substance, when given by oral gavage at a single dose of 2000 mg/kg bw to female Wistar rats was determined in an in vivo according to OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method". No mortality occurred. Hunched posture, piloerection, uncoordinated movements, pale skin and/or pale appearance were noted for the animals between Days 1 and 13. Body weight loss was noted for three animals on Day 8; these animals regained weight during the second week. The body weight gain shown by the other three animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight.