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Administrative data

Description of key information

The oral LD50 value determined in the rat was between 300 and 2000 mg/kg bw.

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:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
300 and 2000 mg/kg body weight (bw)
No. of animals per sex per dose:
3 female rats
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals dosed with 2000 mg/kg bw died during the observation period.
Clinical signs:
other: Clinical cramps, tremor, labored breathing, lateral position and gasping.
Gross pathology:
The necropsy did not reveal any treatment-related findings.
Interpretation of results:
Category 4 based on GHS criteria
Executive summary:

Under the conditions of this study the median lethal dose (LD50) of the test item after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50

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

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. As a result the substance need to be classified and labelled as acute oral category 4 under Regulation (EC) No 1272/2008.