Registration Dossier
Registration Dossier
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EC number: 266-273-5 | CAS number: 66241-11-0 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 53185.
Endpoint summary
Administrative data
Description of key information
The LD50 oral and dermal in the rat is above 2000 mg/kg bw. Leuco Sulfur Black 1 did neither cause lethality nor clinical signs indicative of toxicity in both acute toxicity studies.
Key value for chemical safety assessment
Additional information
The acute toxicity of Leuco Sulfur Black 1 by oral application was investigated according to the OECD Guideline 423 under GLP.
Female rats were treated by oral gavage administration at a dosage of 2319 mg active ingredient / kg bw (corresponding to 4396 mg test item / kg bw).
No deaths occurred during the study. Except for black stained faeces from test day 2 up to test day 5 at the latest, no clinical signs were noted in all animals during the observation time. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The LD50 is greater than 2000 mg/kg bw.
The acute toxicity by dermal application of Leuco Sulfur Black 1 was investigated according to OECD Guideline 402 under GLP.
Five male and five female rats were treated at 2319 mg active ingredient/kg (corresponding to 4396 mg test item / kg bw) by dermal application. The test item was formulated in purified water and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.
No deaths occurred during the study. No clinical signs were observed during the course of the study.
Due to moderate black staining of the treated skin after the removal of the application patch, the assessment of erythema was first prevented on test day 2 in all animals. From test day 3 to test day 7 at the latest, a slight black staining was still present. Erythema was assessable, but not noted in all animals from test day 3 to the end of the study. No oedema was observed throughout the whole observation period. Scaling was observed in one male on test day 4.
The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The LD50 is greater than 2000 mg/kg bw.
An acute inhalation toxicity study has not been performed because exposure of humans via inhalation is not likely due to the physical state (wet paste) and vapour pressure (calculated as 1.8 x 10E-5 hPa at 25 °C) of the substance.
Justification for classification or non-classification
Based on the available data Leuco Sulfur Black 1 is not subject to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC.
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