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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

NOAEL oral rat > 2000 mg/kg bw


 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The acute toxicological characterization of the similar substance 1 was determined by Acute toxicity test, according to the OECD guideline 401 (Stahl, 1996).


Groups of five male and five female Alpk:APfSD(Wistar-derived) rats received a single dose of 2000 mg/ks of the test sample.


The animals were assessed daily for the following 15 days for any signs of systemic toxicity and their bodyweights were recorded at intervals throughout the study. At the end of the study all the animals were killed and subjected to a macroscopic examination post mortem. Following a single oral dose of 2000mg/kg, none of the animals died and there were no significant signs of toxicity.


The acute oral median lethal dose of the tested substance is in excess of 2000mg/kg to male and female rats.


 


Moreover, another test is available on similar substance 2 (Clariant, 1995).


The acute toxicity of the substance was assessed folllowing oral administration in Sprague Dawley rats, by the fixed dose method. The substance was administered at the dose of 2000 mg/kg. None of the animals tretaed at the dose of 2000 mg/kg died in the course of the study.


The only observation made on the day of treatment was the execretion of deeply yellow-coloured urine by all the animals. This observation was also seen on the following day poste-treatment, accompained by black-coloured faeces.


The evolution in the bodyweights of all the animals was normal. In the necropsies there were no alterations detected.


Based on Read Across with similar substance 1 and 2, Acid Green 68 can be considered to have the following results:


No Adverse Effect level for acute toxicity oral is > 2000 mg/kg bw.


Read across is discussed more in detail in the Read Across document in section 13.

Justification for classification or non-classification

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 shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral) or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg for oral  exposure pattern. Therefore no classification for acute toxicity oral is warranted under Regulation 1272/2008.