Registration Dossier
Registration Dossier
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EC number: 216-032-5 | CAS number: 1477-55-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
In accordance with Regulation (EC) 1907/2006, the toxicokinetic behaviour of the substance has been assessed to the extent that can be derived from the relevant available information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
Test Material
The test material consists of a benzoic ring with two amine groups. The test material is a colourless liquid with low vapour pressure, which suggests the substance is unavailable for inhalation as a vapour. The test material is not expected to undergo significant hydrolysis under physiological conditions. In addition, the test material is not readily biodegradable. As a result, exposure to degradants, following oral ingestion, is not expected. The test material has a low log octanol/water partition coefficient value and a very high water solubility, which suggests that the substance is not favourable for absorption in the gastro-intestinal/respiratory tracts, or via skin.
The corrosive nature of the substance has been observed as severe local effects in the rat during a 28 -day repeated dose study and in a reproductive and developmental toxicity study. The substance is a skin sensitiser in two guinea pig maximisation studies. The substance did not show genetic toxicity in vitro or in vivo.
Absorption
The results of the acute oral/inhalation and the oral repeated-dose toxicity studies did not show any significant systemic toxicity to indicate absorption of the substance. This is supported by the physicochemical characteristics of the test material; the low log octanol/water partition coefficient value and the high water solubility would not favour absorption of the test material as it is likely that the material will be highly ionised. The available studies also provided strong evidence of local irritation in the gastro-intestinal tract, which caused the death of animals exposed to high doses. The corrosiveness/skin irritancy of the test substance would have damaged the surface of the skin, which may have enhanced penetration of the substance.
Distribution
There is no evidence to show that the test material is distributed systemically. The results of skin sensitisation studies in the guinea pig showed positive response. This suggests that the test material binds to carrier proteins in the blood. The high water solubility and relatively low molecular weight of the test material will allow it to disperse into the water compartment of blood for distribution. Due to its low potential for bioaccumulation, the test material is unlikely to accumulate in body fat. This conclusion is supported by the low log octanol/water partition coefficient.
Metabolism
The results of the repeated-dose oral toxicity study in the rat did not show any evidence of enhanced metabolism. The test material does not readily biodegrade and, therefore, it is likely to require further metabolism prior to excretion. The results of the in vitro genotoxicity studies show that genotoxicity is neither enhanced nor diminished in the presence of an S9 metabolising system.
Excretion
There is no evidence to indicate the route of excretion of the test material. However, it is likely that the kidney will be a significant route of excretion for a product with high water solubility and relatively low molecular weight. Any test material that is not absorbed will be excreted in the faeces.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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