Registration Dossier
Registration Dossier
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EC number: 278-928-2 | CAS number: 78491-02-8
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The high water solubility (>1g/ml) and low Kow (log Kow <0.9) of the substance being registered suggest significant bioavailability, with absorption being expected following ingestion. Consideration of acute test data however may indicate slightly greater toxicity following parenteral (intraperitoneal injection) exposure compared to oral administration. Skin penetration may be very limited (and a low acute dermal LC50 value supports this hypothesis). The substance acts as a formaldehyde donor: in dry powder form, formaldehyde may make up some 14.8 - 20.6 wt% of the substance (ISP company report, 2013) and in water further formaldehyde release occurs with one substance molecule having a potential for maximal release of four formaldehyde molecules (SCCNFP Opinion 586/02, 2002). The observed (inherent) biodegradability and relative hydrolytic instability (half-life 12h at neutral pH and 20.4C) of the substance support an expectation that enzymic and/or non-metabolic processes will lead to formaldehyde release.
The toxicological profile of the substance may therefore primarily reflect the toxicity of formaldehyde: the effects on stomach lining (target organ fore- and glandular stomach) observed in subchronic oral toxicity studies supports this hypothesis since it resembles effects reported in repeat-dose oral toxicity studies of formaldehyde. A 90-day rat oral NOAEL of 200 mg/kg/day was concluded for the substance being registered here.
In vitro genotoxicity studies showed little difference in toxicity between treatments with and without rat liver derived S9 mix, giving no clear indication of hepatic metabolism of the substance.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
No experimental investigation of adsorption, metabolism and excretion in mammalian systems has been performed. Degradation of the substance within the body by metabolic or other processes can be expected, with associated release of formaldehyde. Little potential for bioaccumulation is indicated by the high water solubility and low log Kow (determined by testing).
An evaluation of ADME data on hydrolysis products is considered to be sufficient to cover the endpoint ADME. Therefore an expert statement on toxicokinetics is attached.
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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