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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a well-conducted OECD combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) by oral gavage in rats  no toxicity occurred up to the highest administered dose of 1000 mg/kg/day. The NOAEL was determined to 1000 mg/kg/day.
With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substances. Taken as a whole there are sufficient data available for the long-chain alkyl methacrylate esters for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies.

Key value for chemical safety assessment

Additional information

In a well-conducted OECD combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) by oral gavage in rats, no toxicity occurred up to the highest administered dose of 1000 mg/kg/day.

The NOAEL for the repeated dose toxicity by oral gavage was determined to 1000 mg/kg/day.

Supporting information: In an OECD guideline 408 90-day gavage study in Wistar rats with the C8 Ester 2-ethylhexyl methacrylate, including a recovery period of 28 days, signs of general systemic toxicity occurred in male as well as female rats at 360 mg/kg bw/day. The NOAEL was120 mg/kg bw/day in males and females.

 

There are no data available for repeated dose exposure by the dermal or inhalation route. With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. This skin absorption study indicates that the total amount of the ester dodecyl methacrylate that was absorbed during the time of exposure was 0.7 % (rat epidermis) and 0.26 % (rat whole skin) over 24 hours, respectively. Thus, toxic effects via the dermal route are unlikely. The inhalation route is not of relevance due to the very low vapour pressure of the substances. Taken as a whole there are sufficient data available for the long-chain alkyl methacrylate esters for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies.

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

- No classification required.

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- No classification required.