Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

As stated in 8.6.1. of annex VIII and 8.6.2. of Annex IX, repeated toxicity testing needs to be performed using the most appropriate route of administration, having regard to the likely route of human exposure. Also according to 8.6.1. of annex VIII and 8.6.2. of Annex IX, testing by the dermal route is appropriate if:

(1) skin contact in production and/or use is likely; and
(2) the physicochemical properties suggest a significant rate of absorption through the skin; and
(3) one of the following conditions is met:
- toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, or
- systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, or
- in vitro tests indicate significant dermal absorption, or
- significant dermal toxicity or dermal penetration is recognised for structurally-related substances.

1,1-dichloroethene is used in industrial settings and its physiochemical characteristics (high volatility, high flammability) require well confined systems. Therefore, significant dermal exposures are unlikely. Moreover even though 1,1-dichloroethene shows a certain potential for dermal absorption, its high volatility will most probably cause that the toxic dose via the dermal route will be lower as compared to the inhaled or oral route. This latter assumption is supported by the observations made by Fasano et al., 2008, where the in vitro dermal absorption study was hindered by the high volatility of 1,1-dichloroethene. Based on the above, it is considered that repeated dose toxicity testing via dermal route can be waived.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion