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Diss Factsheets

Administrative data

Description of key information

An acute oral lethality study was conducted on C4 Methacrylate and an acute dermal lethality study was conducted on a C4 Acrylate (structural analogue):

The acute oral LD50 is greater than 2,000 mg/kg when tested according to OECD 420 (2001).

The acute dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402 (1987).

Key value for chemical safety assessment

Additional information

The acute oral toxicity of the test article was evaluated in female Wistar Hannover rats. The study was conducted according to OECD 420 (2001) and was conducted in compliance with OECD GLP (1997) regulations. The test article was homogenized in corn oil and administered to 5 female rats via oral gavage at a dose volume of 10 mL/kg. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality, abnormal clinical signs or macroscopic findings after necropsy were observed and the body weight gain shown by the animals was considered normal. Based on the results of the study, the test article has a rat oral LD50 greater than 2,000 mg/kg body weight.

The acute dermal toxicity results for C4 sulfonamido acrylate (CAS 67584 -55 -8) are reported for read across to C4 sulfonamido methacrylate (CAS 67584 -59 -2). The acute dermal toxicity of MTDID 7831 (off-white to white waxy solid, composition 93.96 w%, Batch 40177) was evaluated in Wistar rats. The study was performed in compliance with OECD GLP (1997). The study design was based on OECD No 402 (1987), EC 440/2008 B3 L142 (2008), EPA OPPTS 870.1200 (1998), and JMAFF No. 8147 (2011). The test article was prepared in polyethylene glycol (w/w) and dermally applied to a 5 x 7 cm area of clipped fur on male and female rats (5/sex) for a single application at a 2000 mg/kg body weight (10 mL/kg) dose. The application represented 10% total body surface of the rats and was applied with a gauze patch backing and covered in aluminum foil, an elastic bandage, and tape (females only). After 24 hours, the dressing was removed and the skin cleaned of any residual test substance with tap water. Observations were made for mortality (twice daily), body weights (Day 1, 8, and 15), and clinical signs of toxicity (Days 1-15). All animals were euthanized at the end of Day 15 and a necropsy was performed. All animals survived for the length of the study and no abnormalities were found at time of necropsy. Hunched posture (1 male), chromodarcryorrhoea (2 males and 3 females), and pilioerection (1 female) were noted only on Day 1. Body weights were within a historical expected range for the duration of the study. Based on the results of the study, the dermal LD50 of the test article is greater than 2000 mg/kg body weight.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, data gaps for mammalian toxicity can be addressed by read across. The read across is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.

Justification for classification or non-classification

Based on the results of the studies, C4 Methacrylate does not meet the GHS classification criteria for acute lethality.