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EC number: 944-218-2 | CAS number: -
The acute oral LD50 of FAT 40000/G in rats of both sexes observed over a period of 14 days is >2000 mg/kg bw. Similarly, the dermal LD50 was considered to be > 2000 mg/kg bw based on the available data with a structurally similar substance.
The test article FAT 40000/G was administered to groups of 5 male and 5 female rats by oral gavage, at single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of FAT 40000/G in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered test substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin with a syringe and covered with an occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. Therefore, the toxicity of the test substance was estimated to be >2000 mg/kg bw.
Acute oral toxicity:
A key study was performed for FAT 40000/G which was administered to groups of 5 male and 5 female rats by oral gavage, at single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of FAT 40000/G in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. Several other studies conducted with different batches of the test item more or less confirmed the non-toxic behaviour of the substance. Therefore effects of different batches of the test item can be ruled out.
Several other supporting studies were also performed with following results:
LD50 - >5000 mg/kg bw
LD50 - 14530 mg/kg bw
Acute inhalation toxicity:
Currently no study to assess acute inhalation toxicity is available. However,due to the intrinsic properties of the test item (reactive yellow 095 is considered to have low volatility as the melting point >300 °C, while it has high water solubility of 366 g/L, indicating if vapours are produced will be trapped in the mucus) and the high values of the acute oral toxicity studies available, no effect beside sensitization are expected via the inhalation route. Experience with similar chemical structures demonstrated that it is very unlikely that toxicity related to intrinsic properties of the test item (beside effects of respiratory sensitization) only show up via the inhalation route and not via the oral-gastric route of exposure. Hence, the study is considered scientifically not necessary.
Acute dermal toxicity:
Currently no study to assess acute dermal toxicity of REACTIVE YELLOW 095 is available. However, REACTIVE YELLOW 175 was evaluated for the acute toxicity via dermal route.
In this GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered REACTIVE YELLOW 175 at the dose of 2000 mg/kg bw (RCC 1987). No mortality was observed during the observation period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. Therefore, the dermal LD50of the test substance was estimated to be >2000 mg/kg bw.
The molecular weight of REACTIVE YELLOW 095 is 797.1 g/mol, which indicates substance is too large for dermal absorption. The high water solubility (366 g/L) and low partition coefficient (log Pow = -5.7) of REACTIVE YELLOW 095, indicate the substance may be too hydrophilic to cross the lipid rich environment of thestratum corneum. Hence, the dermal uptake for the substance is expected to be low. Further, the absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further supports the conclusion that low acute toxicity is expected via dermal route. Taking into consideration the above discussion and the results of acute dermal toxicity with source REACTIVE YELLOW 195, no hazard is expected in case of dermal exposure of REACTIVE YELLOW 095, hence further experiments to assess dermal toxicity are not taken into account.
Based on the available data from acute toxicity studies with FAT 40000, the test substance does not meet the criteria for classification for acute toxicity according to the CLP (1272/2008) Regulation.
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