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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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(oral) = 560.4 mg/kg bw (based on active ingredient)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
560.4 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 toxicity of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance.

A complete summary of the available data is attached. The results of the tests are concordant exept one study conducted on an undefined zink salt that can be considered as disregarded.

The study selected as the most representative and conservative was performed on Similar Substance 04 [DyStar Colours Distribution GmbH, 1985], according to a method similar to OECD 401. Under the test condition the substance sowed an LD50 = 934 mg/kg bw based on nominal concentration, corresponding to LD50 = 560.4 mg/kg bw based on active ingredient.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

 

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

 

Taking into account the information available (LD50 = 560.4 mg/kg bw based on active ingredient) the substance has to be classified as Category 4 (H302) for acute oral toxicity.