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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Oral  toxicity study in male and female Wistar rats 
Testing facility: Bayer Industry Services, Leverkusen
Study no. T2070311 performed on April 3, 2001.
The registrant has a Letter of Access.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The study was conducted in accordance with OECD no.423 "Acute oral Toxicity - Acute Toxic Class Method" and Annex IVB, Part B.1 tris (Acute toxicity oral - Acute Toxic Class Method) to Directive 67/548/EEC of the Council of the European Communities of June 27, 1967 in its current version as amended for the twenty-second time by Dir.96/54/EEC and followed, in principle, the Health Effects Test guidelines (OPPTS 870.1100).

Additional information

A group of six fasted Wistar rats (3 males and 3females) received a single oral gavage dose of the test substance formulated in demineralized water with the aid of Cremophor EL 2% (v/v) and administered at a dose level of 2000 mg/kg bw.

At 2000 mg/kg in males and females the motility was decreased and both sexes showed piloerection, bradypnea and narrowed palpebral fissures. Additionally to the signs described above, in females reactivity was decreased, lacrimation increased, feces decreased (constipation) and eyelids closed. In one male rat diarrhea was observed. The signs observed started 20 minutes after administration and lasted until 2 days of the study.

No treatment effects on the body weight were observed.

The gross pathology investigations performed at the end of the post-treatment observation period did not afford any treatment-related findings.


Justification for selection of acute toxicity – oral endpoint
One available study

Justification for classification or non-classification

LD 50 rat > 2500 mg/kg bw

Based on the study, the test substance is to be regarded as relatively non toxic and not to be classified.