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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute toxicity in rats

LD50 > 5000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

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

A sample with low purity (ca. 30 % dye) was tested for acute oral toxicity to rats. Apart from the dye, remaining components were mainly sodium lignosulphonate as dispersant (69 %) and dedustant (1 %).

12.5 ml/kg of suspension with test substance was administered to male and female rats (5 sex/dose) by gavage. Doses of test substance were 0 mg/kg (control) and 5000 mg/kg. Only one female rat died after dosing. Therefore, LD50 > 5000 mg/kg was found.

Signs of treatment reaction were noted, e.g. pilo-erection, hunched posture, waddling. Recovery of survivors was complete within 3 days, as shown by normal bodyweight gains and normal autopsy findings.

Lethargy, pallor of extremities and ptosis was noted in one female prior to death. Such female showed congestion of lungs, pallor of liver, kidneys and spleen at autopsy.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as LD50 (oral, dermal) or LC50 (inhalation) values as well as acute toxicity estimates (ATE).

 

In available studies in rats, oral LD50 values above 2000 mg/kg bw were found. Accordingly, target substance was not classified for acute oral toxicity in the CLP Regulation (EC 1272/2008).