Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 acute oral toxicity of the test item 2-Nitro-5-amino bentsotrifluoride ( 4-Nitro-3-(trifluoromethyl)aniline) was evaluated in female Sprague Dawley rats according to OECD 423, EC 2008/440/EC B.1 tris, US EPA OPPTS 870.1100 guidelines and in compliance with GLP. The test substance induced mortality in the rat following oral administration of a single dose at levels of 2000 and 300 mg/kg. Main clinical sings after 2000 mg/kg were reduced activity, ataxia and moribund status and after 300 mg/kg reduced activity, lethargy, prone posture and moribund status. Gross pathology examination showed abnormal colour and/or abnormal contents in the parts of Gastrointestinal track, Abdominal cavity, Cranial cavity and Thoracic cavity at dose 2000 mg/kg. At 300 mg/kg dose decedent animals showed yellow stainign of the urogenital region. No mortality or other relevant signs of toxicity were observed following dosing at 50 mg/kg. The results suggest the LD50 to be greater than 50 mg/kg but lower than 300 mg/kg bw and indicate the classification of Acute Oral Toxicity Category 3.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
Guideline GLP study

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

Study result Oral LD50 > 50 - < 300 mg/kg bw.

Classification for acute oral toxicity required under Regulation EC 1272/2008:

Classification: Category 3

Signal word: Danger

Hazard statement: H301 Toxic if swallowed