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Administrative data

Description of key information

In a subacute study Reinblau RLW Tr. (CAS 41611-76-1) was administered by oral gavage to male and female SD rats for 28 days at dose levels of 0, 8, 40, 200, and 1000 mg/kg to asses its toxicity and reversibility. 
Due to the close structural similarity of Reinblau RLW (CAS 41611-76-1) and Reinblau BLW (1,4-bis[(2,6-diethyl-4-methyl- phenyl)amino]anthraquinone (CAS-No. 32724-62-2) has an additional ethylgroup in the aromatic side chains in relation to with1,4-bis(2-ethyl-6-methy1anilino) anthraquinone (CAS-No. 41611-76-1), the similar physicochemical and toxicological properties a read-across between the 2 compounds is justified.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The materials/methods and results are described in detail und are sufficient for evaluation

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There were no test substance-related toxic changes of Reinblau RLW in clinical signs, body weight, food consumption, hematology, blood chemistry, urinalysis, organ weight, necropsy, or histopathology.

Therefore, the no-observed-effect-level (NOEL) of Reinblau RLW Tr. was considered to be 1000 mg/kg for male and female rats.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
key study for repeated dose toxicity of 1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone (CAS 41611-76-1) is used.

Justification for classification or non-classification

Due to the results of the subacute toxicity study were no effects in any parameters examined were found, a classification is not justified.

This result is also valid for Reinblau BLW (1,4-bis[(2,6-diethyl-4-methyl- phenyl)amino]anthraquinone (CAS-No. 32724-62-2).