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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The oral LD50 in Wistar rats was established as exceeding 2000 mg/kg body weight.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: ECHA provided robust study summary
Qualifier:
according to guideline
Guideline:
other: Annex V (Acute toxic class)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Dose level (volume): 2000 mg/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Clinical signs noted during the study were lethargy, hunched posture, ventro-lateral recumbency, uncoordinated movements and piloerection were observed in the majority of animals between days 1 and 2. Rales were n
Gross pathology:
Effects on organs: No abnormalities were noted at necropsy of animals killed at the end of the study period.
Interpretation of results:
other: not classified Migrated information
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in Wistar rats was established as exceeding 2000 mg/kg body weight.
Executive summary:

The test item was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. No mortality occurred. Lethargy, hunched posture, ventre-lateral recumbency, uncoordinated movements and piloerection were observed in the majority of animals between days 1 and 2. Rales were noted in one animal on day 3. No abnormalities were found in the animals at macroscopic post mortem examination. The oral LD50 value of the test item in Wistar rats was established as exceeding 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

The test item was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. No mortality occurred. Lethargy, hunched posture, ventre-lateral recumbency, uncoordinated movements and piloerection were observed in the majority of animals between days 1 and 2. Rales were noted in one animal on day 3. No abnormalities were found in the animals at macroscopic post mortem examination. The oral LD50 value of the test item in Wistar rats was established as exceeding 2000 mg/kg body weight.

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 is not classified and labelled as acute toxic according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.