Registration Dossier

Diss Factsheets

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:
other:
Justification for type of information:
Tests in aqueous media with ethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations can not be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture ethyl 2-cyanoacrylate polmerises within seconds (inherent property of ethyl 2-cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water represent a non ateady state situation from which a defined effective concentration can not be derived. Oral administration would be the most appropriate way. The monomer would polymerized in the oral cavity or when administered by gavage in the stomach. The application in the feed is not possible, as the monomer polymerizes immediately on contact with food. This would allow only the polymer to be tested.
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:
other:
Justification for type of information:
Tests in aqueous media with ethyl 2-cyanoacrylate with the intent to determine effective concentrations or no effect concentrations can not be performed due to technical reasons based on the chemical properties of the monomer. In presence of moisture ethyl 2-cyanoacrylate polmerises within seconds (inherent property of ethyl 2-cyanoacrylate based instant glues). Thus, very low determined monomer concentrations in water represent a non already state situation from which a defined effective concentration can not be derived. Oral administration would be the most appropriate way. The monomer would polymerized in the oral cavity or when administered by gavage in the stomach. The application in the feed is not possible, as the monomer polymerizes immediately on contact with food. This would allow only the polymer to be tested.
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

Additional information

Categories Display