Registration Dossier
Registration Dossier
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EC number: 211-190-1 | CAS number: 633-03-4
Endpoint summary
Administrative data
Description of key information
Oral toxicity: LD50 of 674 mg/kg (based on similar substance)
Dermal toxicity: LD0 of 2000 mg/kg b.w (based on similar substance)
Inhalatory exposure is unlikely
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 674 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 adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
There are some available studies to assess acute oral toxicity.
LD50 of 674 mg/kg has been chosen as the most conservative and reliable data because the study was complete and good conducted, with all tables and graphics reported.
The outcomes from Clemmensen et al (1984) report were previously accepted to classify similar substance for oral acute toxicity; this classification is today confirmed by Dystar studies.
Furthermore it has been chosen as the most conservative data the LD50 value reported by Dystar because Clemmensen study does not report any details and information on test conditions.
In the study of Clemmensen et al, (1984) it is reported that no systemic effects were seen after dermal application of 2000 mg/kg b.w.
Inhalator exposure is unlikely; nevertheless in a study on teratogenical effects on rabbits (Meyer and Jorgenson, 1983) the authors reported that if MG during gavage was coughed up and aspirate into the lungs, those animals died within minutes of acute pulmonary toxicity.
Justification for selection of acute toxicity – oral endpoint
Most conservative and reliable data.
Justification for classification or non-classification
All results confirmed the outcomes of Clemmensen, that were previously accepted to classify Malachite Green Acetate for oral acute toxicity.
According to CLP regulation (EC1272/2008) Malachite Green Acetate is classified as Acute toxicity 4, H302
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