Registration Dossier
Registration Dossier
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EC number: 461-870-9 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regards to the toxicokinetics of Reaktiv Gelb 201. The data indicate that there is little or no dermal absorption. No signs of a significant systemic absorption potential have been observed. A bioaccumulation ofReaktiv Gelb 201can most probably be excluded due to the marked hydrophilic properties. Based on the results of all mutagenicity assays, a metabolisation towards genotoxic sub-structures can most probably be ruled out.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. An approximate indication of the toxicokinetic pattern can be gained from the physico-chemical properties (solubility in solvents, log Kow, hydrolytic stability) and the results of basic toxicity testing of the test article. The assessment of the toxicokinetic properties of Reaktiv Gelb 201 given below is based on the results obtained for, the following toxicological endpoints:
- acute oral toxicity
- acute dermal toxicity
- skin irritation
- eye irritation
- skin sensitization
- subacute (28 day) oral toxicity
- bacterial reverse mutation test
- chromosome aberration test in vitro
All studies were carried out according to the principles of Good Laboratory Practice and met the requirements of the OECD and EU-Guideline for the Testing of Chemicals. The studies are conducted on the free acid form; however this would not affect the toxicological significance, as once the salt form undergoes physiological exposure, the forms would be similar to those anticipated from the acid.
Physico-chemical properties
Reaktiv Gelb 201 has a molecular weight of 480.52 g/mol as acid and 525.5 g/mol as disodium salt, a water solubility of 32.6 g/L and a log Kow of < -4.35.
Toxicological Profile:
The medial lethal dose (LD50) of Reaktiv Gelb 201 after oral or dermal administration to rats is above 2000 mg/kg body weight. Testing for skin irritating properties in rabbits showed no signs of irritation. After administration into the conjunctival sac of New Zealand White rabbits signs of irritation were noted. Testing for sensitizing properties according to the method of Magnusson & Kligman showed no evidence for skin sensitization properties. In the 28 d study a NOAEL of 1000 mg/kg bw/day was determined.
In the Ames Test the substance did not cause any relevant increases in the number of revertant colonies with any of the tester strains and is assessed to be non mutagenic. In the chromosome aberration study in vitro with V79 Chinese hamster cells no relevant reproducible enhancement of metaphases with aberrations outside the range of the solvent control was found with any of the concentrations used, either with or without metabolic activation by S9-mix indicating that the substance is not clastogenic in this in vitro test system.
Evaluation and Assessment
The data of the acute dermal toxicity, dermal irritation and skin sensitization test indicate little or no dermal absorption, owing to the fact that no irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of Reaktiv Gelb 201. Oral resorption of the substance is obviously possible in spite of the low log Pow. This can be concluded from feces discolorations observed in the subacute toxicity study. Due to the physico-chemical properties, an accumulation of the dye in the fatty tissues of the body is unlikely. The test substance is eliminated efficiently via faeces, as demonstrated by faeces discolorations in the subacute toxicity study. In summary based on the high water solubility, low log Pow and the results obtained in various toxicological examinations it can be concluded that Reaktiv Gelb 201 does not show any toxicokinetic peculiarity.
Summary
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regards to the toxicokinetics of Reaktiv Gelb 201. The data indicate that there is little or no dermal absorption. No signs of a significant systemic absorption potential have been observed. A bioaccumulation ofReaktiv Gelb 201can most probably be excluded due to the marked hydrophilic properties. Based on the results of all mutagenicity assays, a metabolisation towards genotoxic sub-structures can most probably be ruled out.
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