Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate] and tetrasodium 4-[[1-hydroxy-6-[[[[5-hydroxy-6-[(2-methyl-4-sulphonatophenyl)azo]-7-sulphonato-2-naphthyl]amino]carbonyl]amino]-3-sulphonato-2-naphthyl]azo]benzoate and tetrasodium 4,4'-[carbonylbis[imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]dibenzoate
EC number: 942-930-8 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
In the absence of experimental data, for the oral, dermal and inhalatory route, the default absorption values from the REACH guidance (Chapter 8, R.8.4.2) are used for DNEL derivation.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
Since no toxicokinetic studies are available for the test substance the following assessment is based on the available physicochemical properties and results from other toxicological studies.
The substance is a red brown powder. The molecular weight of the three constituents range from 891 to 989 g/mol. The calculated log Pow is -6 and the solubility in water is 200 – 300 g/L.
Gastrointestinal absorption: Water soluble substances may readily dissolves into the gastrointestinal fluids. However, absorption of hydrophilic substances by passive diffusion may be limited by the rate at which the substance partitions out of the gastrointestinal fluid. The high molecular weight of the test substance does also not favor absorption. In the two repeated dose studies performed with a structural analogue no toxic effects were observed up to the highest dose (1000 mg/kg bw/day for 30 days) tested. In conclusion, the test substance may not be readily absorbed by the gastrointestinal tract.
Dermal absorption: The high water solubility (>10000 mg/L) and the log Pow lower than -1 suggests that the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Furthermore, the molecular weight of the substance may be too large. Finally, in the acute dermal toxicity study no systemic effects were observed after exposure to 2000 mg/kg bw. Therefore, dermal uptake will be very unlikely.
Respiratory absorption: No experimental data is available concerning the respiratory hazard of the test substance. Water soluble dust would readily diffuse/dissolve into the mucus lining of the respiratory tract. However, very hydrophilic substances can be transported out of the respiratory tract, when molecular weights are larger than 200. Furthermore, the low log Pow does not favor absorption. Therefore, the test substance may not be readily absorbed by the respiratory tract.
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