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Administrative data

Description of key information

NOAEL = 7 mg/kg bw day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
7 mg/kg bw/day
Study duration:
chronic
Species:
rat

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

In the Culp (1999) study it was recorded a slight Liver/Body weight ratio increase in rats (both sexes) starting from 300 ppm dose and other effects starting from 1200 ppm. All endpoints are more pronounced on females. Effects on mice are much lower. NTP technical report (2004) is more detailed and exhaustive; it seems that the study is exactly the same reported by Culp in "Chemio-Biological Interactions 122 (1999) 153-170", but we reported them separately because many details are described differently. Translating the ppm in feed into taken substance, a NOAEL of 10 mg/kg on rat was reported. This value can be refined with the cancerogenicity test (Culp 2006), which indicates

the NOAEL for non-cancer

effects at mg MG/kg diet, equal to 7 mg MG/kg bw per day.

Justification for classification or non-classification

In the following the agreed proposal from CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES European commission of June 2005

Repeated dose toxicity

The repeated-dose toxicity of malachite green has been investigated in two 28-day studies in rats and one study in mice. The main findings in both species were limited to effects in the liver including; an increase in relative liver weight and minimal to mild hepatocyte vacuolisation. Changes in T3 and T4 levels in the thyroid also occurred in rats. These findings do not indicate significant toxicity following repeated dosing at doses relevant for classification. Agreed for no classification.

According to CLP regulation (EC1272/2008) Malachite Green Acetate and the decision of is not classified for Repeated dose Toxicity.