[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

impurity 1

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 mg/kg; 2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Treated animals were checked for mortality and moribundity twice daily starting from the dosing day to the day before necropsy. No mortality during the study period. Increased activity was observed in three animals at 300 mg/kg at 4 hours post-dose. The clinical sign was not considered to be test related.

Clinical signs:

other: Treated animals were observed by detailed clinical examinations at 0.5 and 4 hours after dosing on D1, and at least once weekly starting from the dosing day to the day before necropsy. Other days, cage-side observation was conducted.

Gross pathology:

Gross necropsy was performed on all animals at the end of study (D15). The animals were euthanized by carbon dioxide exposure followed by exsanguinations and necropsied. The external surface of the body and all organs/tissues in the thoracic and abdominal cavaties were examined. No gross lesion was found in all animals

Any other information on results incl. tables

There was no mortality occurred. Three animals at 300 mg/kg showed increased activity at 4 hours after dosing but were not considered to be test article-related or toxicological effects. All animal body weights increased and no gross lesions were found at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not classified

Executive summary:

A single oral dose of the test substance, given to female rats at 300 or 2000 mg/kg, none animal was found dead. The test substance in GHS system and the harmonized LD50 cut-off values are classified to category 5/unclassified and 5000 mg/kg, respectively.