Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
5 000 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

No information on "acute oral toxicity" is available for the Target Substance. However data on Similar Substance 02 has been taken into account for the assessment. More details about the similarity between the two substances are reported in section 13.

An in-vivo study for acute toxicity by oral route has been carried out according to a guideline similar to OECD 401 (only two doses tested). Male and female rats were administered 5000 mg/kg bw of a mixture with 50 % of the dye. No mortality was observed and therefore the LD50 or LD0 was set equal to 5000 mg/kg bw.

A study on acute toxicity by intraperitoneal route was carried out on the same test substance. The LD50 calculated in this tes was between 700 and 2000 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity.