Registration Dossier
Registration Dossier
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EC number: 205-275-2 | CAS number: 137-05-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
It is technically challenging to investigate the toxicological effects of methyl 2 -cyanoacrylate (MCA), as the substance immediately polymerizes in contact with water. The monomer would therefore polymerize in the oral cavity or when administered by gavage in the stomach. The application in the feed is not possible, as the monomer also polymerizes immediately on contact with food. Consequently, only the polymer can be tested. As explained in more detail in the chapter 'toxicokinetics, metabolism and distribution', a degradation of the MCA polymer occurs in vivo after oral application, resulting in the release of MCA monomer. Thus, an evaluation of toxic effects after repeated dosing can be done on the basis of oral repeated dose studies conducted with the MCA polymer.
Two repeated dose toxicity studies with MCA polymer are available in literature (Page et al., 1966). Rats or dogs received doses up to 200 mg/kg b.w./d by gavage. In all studies, no adverse effect was observed up to the highest dose tested. The 90 day-studies with rats and dogs resulted in a NOAEL of >200 mg/kg b.w./day.
Furthermore, one subacute study with structural homologue (BCA polymer) is published in literature. Rats received up to 6400 mg polymer per day for 10 days. No adverse effect was observed in this study, either.
The 90 day study with rats was used to derive the systemic DNEL, as the time span of exposure was the longest in relation to the lifetime of the tested species.
Justification for classification or non-classification
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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