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Administrative data

Description of key information

Oral: LD50= LD50 cut-off > 5000mg/kg bw, female rat, OECD 423, Wil Research B.V. 2015

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH..

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

OECD TG 423, 2015 - The study was performed according to OECD TG 423 and EU Method B1 tris Acute Toxicity, US EPA OPPTS 870.1100 and Japanese JMAFF guidelines and in accordance with GLP to assess the acute oral toxicity of the test material following a single oral administration in the female Wistar strain rat by the acute class method. The test substance was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Hunched posture and piloerection were noted for all animals on Days 1 and 2. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD TG 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.