Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity study, an LD50 value of greater than 125 mg/kg bw to below or equal 312 mg/kg bw was determined (recalculated based on dye content of registered substance (72% w/w) versus tested material (45% w/w)). (BASF AG, 2000)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
125 mg/kg bw

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 acute oral toxicity of the test substance was determined according to OECD guideline 423 and EU method B.1 tris (BASF AG, 2000). Two groups each of six fasted animals (three males and three females) were given a single oral dose of the test material preparation in aqua bidest. at dose levels of 500 mg/kg and 200 mg/kg body weight (gavage). Signs of toxicity noted in the 500 and 200 mg/kg dose group comprised impaired and poor general state, dyspnoea, apathy, abdominal position, staggering, diarrhea, lilac discoloured feces and urine. The surviving animals appeared normal within 6 days after application. The expected body weight gain was generally observed in the course of the study. 1 male and 1 female animal of the 500 mg/kg dose group were found dead 1 day after application. Delayed mortality (5 days after application) was observed in another female. No mortality occurred in the 200 mg/kg dose group. Necropsy findings of the animals that died comprised dilation and liquid contents of the stomach, discolouration of contents of the stomach, small intestine and large intestine and discolouration of the adrenal glands. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 200 mg/kg and less or equal to 500 mg/kg body weight. With regard to the actual test item composition the median lethal dose was recalculated to greater than 125 mg/kg and less or equal to 312 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as acute tox. cat. 3, H301 "Toxic if swallowed" under Regulation (EC) No 1272/2008, as amended for the sixth time in Directive EC 605/2014.