Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Alkyl 2-cyanoacrylates such as ethyl 2-cyanoacrylate (ECA) are known to polymerize rapidly in the presence of water. Even the moisture in the surrounding, e. g. on the skin or in ambient air, is sufficient to start the polymerization process. As described by Krall et al., alkyl 2-cyanoacrylates "polymerize on and adhere to moist living tissues" (Krall, 1983). This effect triggered also the use of this substance class as tissue adhesives in medical applications.

Within seconds, a significant amount of the initial ECA monomer forms a hardened mass. The formation of the polymer in the stomach after application via gavage was also described in the acute oral toxicity studies with ECA (see also chapter 'acute toxicity'). This intrinsic property to polymerize in the presence of water limits the absorption of cyanoacrylates via all routes (oral, dermal, inhalation), and excludes the posibility of a chronic exposure to the ECA monomer.

References:

Krall R. E., Neuwirth R. S. and Richart R. M., Pharmacology and Toxicology of Methyl Cyanoacrylate, Fem. Transcervic Steril., Proc. Int. Workshop, 1983, pp175 -185

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

REACH_data waiving | Developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Remarks:
Species 1 (rat)
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
other:
Species:
rat
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification