Registration Dossier
Registration Dossier
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EC number: 248-670-5 | CAS number: 27816-23-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Additional information
Stability testing demonstrated that 2-methoxyethyl 2-cyanoacrylate is a reactive molecule which polymerizes immediately on contact with moisture, so polymerization will occur during oral administration. Due to this high reactivity the determination of a NOAEL or LOAEL is not possible as 2-methoxyethyl 2-cyanoacrylate is not bioavailable after administration and any effect would originate from the resulting polymer or degradation products thereof.
The nature of the substance does not allow to be tested for the endpoint Toxicity to Reproduction due to the physico-chemical characteristics of 2-methoxyethyl 2-cyanoacrylate. Conform Annex XI section 2 of REACH (Regulation (EC) No 1907/2006) the developmental toxicity study is waived.
Effects on developmental toxicity
Description of key information
Stability testing demonstrated that 2-methoxyethyl 2-cyanoacrylate is a reactive molecule which polymerizes immediately on contact with moisture, so polymerization will occur during oral administration. Due to this high reactivity the determination of a NOAEL or LOAEL is not possible as 2-methoxyethyl 2-cyanoacrylate is not bioavailable after administration and any effect would originate from the resulting polymer or degradation products thereof.
The nature of the substance does not allow to be tested for the endpoint Toxicity to Reproduction due to the physico-chemical characteristics of 2-methoxyethyl 2-cyanoacrylate that:
- dramatically limit or exclude testing of certain assays since its reactivity with water results immediately into a polymer;
- may also prevent administration of precise and consistent doses of the chemical for both in vitro studies and in vivo studies.
Therefore, as it is described in the Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements chapter (R.5.2.2 Testing is technically not possible (page 28)) the waiver is herewith justified.
Conform Annex XI section 2 of REACH (Regulation (EC) No 1907/2006) it is possible omit any required information under the justification that testing is technically not possible thus the developmental toxicity study is waived.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Additional information
Stability testing demonstrated that 2-methoxyethyl 2-cyanoacrylate is a reactive molecule which polymerizes immediately on contact with moisture, so polymerization will occur during oral administration. Due to this high reactivity the determination of a NOAEL or LOAEL is not possible as 2-methoxyethyl 2-cyanoacrylate is not bioavailable after administration and any effect would originate from the resulting polymer or degradation products thereof. Thus, in accordance with annex XI section 2 of Regulation (EC) No 1907/2006 testing of 2-phenylethyl cyanoacrylate on developmental toxicity is waived.
Justification for classification or non-classification
No developmental toxicity or toxicity to reproduction is expected as bioavailability of 2-methoxyethyl 2-cyanoacrylate is unlikely due to its high reactivity with water.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
