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Description of key information

The LD50 was determined to be > 2000 mg/kg bw in male and female rats after oral treatment with the test item (reference 7.2.1-1).

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:
not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.1
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
No further information provided in SNIF.
Route of administration:
oral: unspecified
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
No further information provided in SNIF.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
No further information provided in SNIF.
Statistics:
No information provided in SNIF.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
No mortality was observed.
Clinical signs:
other: Pilo-erection and/ or hunched posture were observed in 8 animals 4 h after treatment. No other signs of systemic toxicity were noted during the study.
Gross pathology:
No macroscopic abnormalities were recorded after necropsy of all animals at the end of the study.
Other findings:
No further information provided in SNIF.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be > 2000 mg/kg bw in male and female rats after oral treatment with the test item.
Executive summary:

In an acute oral toxicity study conduced using the standard acute methods each five male and female rats were treated with the test item. All animals received 2000 mg/kg bw of the test item. No mortality was observed.Pilo-erection and/ or hunched posture were observed in 8 animals 4 h after treatment. No other signs of systemic toxicity were noted during the study.No macroscopic abnormalities were recorded after necropsy of all animals at the end of the study. Based on these observations the LD50 was determined to be higher than 2000 mg/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The study is sufficient to cover the endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study conduced using the standard acute methods each five male and female rats were treated with the test item. All animals received 2000 mg/kg bw of the test item. No mortality was observed.Pilo-erection and/ or hunched posture were observed in 8 animals 4 h after treatment. No other signs of systemic toxicity were noted during the study.No macroscopic abnormalities were recorded after necropsy of all animals at the end of the study. Based on these observations the LD50 was determined to be higher than 2000 mg/kg bw in rats.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item does not require classification for acute toxicity via the oral route according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.