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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on mortality data at doses of 80 - 2000 mg/kg, the acute oral LD50 of this substance is considered to be 455 mg/kg bw (Atochem, 1989). Toxicity was recognised immediately after dosing.
Based on mortality data at doses of 200 - 2000 mg/kg, the acute dermal LD50 of this substance is considered to be 419 mg/kg bw (Atochem, 1989). Toxicity was recognised immediately after dosing.
Based on mortality data at concentrations of 0.11 - 1.08 mg/L, the acute inhalation LC50 of this substance is considered to be 220 mg/m³ (BASF AG, 1979). The LC0 was estimated to be 90 mg/m³.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
455 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
220 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
419 mg/kg bw

Additional information

There are various study results available on the acute toxicity of the test substance by different administration routes. Fourteen reports on the acute toxicity via oral, dermal, inhalation or other routes to rats, mice or rabbits were reviewed.

 

Oral exposure route:

Regarding acute oral toxicity, the study by Atochem (1989) was considered to be the most reliable and was identified as the key study because it was well conducted according to OECD TG 401 in compliance with GLP. In this study, SD rats (5 animals/group/sex) were administered doses of 0 (vehicle; paraffin oil), 80, 160, 320, 640 and 2000 mg/kg. Mortality was noted principally within one day after dosing. Necropsies did not reveal any significant gross lesions. No sex-related differences in toxicity were noted. The acute oral toxicity LD50 is considered to be 455 mg/kg bw.

Four other acute oral LD50 values in rats were reported to be in the same range of magnitude. These studies do not provide additional information on the acute oral toxicity of the test substance (BASF AG, 1989; BASF AG, 1979; Atochem, 1985; Allied Colloids, 1989).

 

Dermal exposure route:

Regarding acute dermal toxicity, the study in rats by Atochem (1989) was identified as the key study because it was conducted according to OECD TG 402 in compliance with GLP. SD rats (5 animals/group/sex) were administered doses of 200, 330, 500, 700, 980, 1400 and 2000 mg/kg bw. Mortality was noted principally within one day after dosing. Necropsies did not reveal any abnormalities except cutaneous effects at the site of application. No sex-related toxicity was observed. According to this study, the acute dermal toxicity LD50 is considered to be 419 mg/kg bw.

Another GLP-study in rats according to OECD TG 402 resulted in an acute dermal LD50 value of 891 mg/kg bw (Allied Colloids, 1989). A study in rabbits revealed an acute dermal LD50 range of > 50 - < 200 mg/kg bw (BASF AG, 1979).

 

Inhalation exposure route:

Regarding acute inhalation toxicity, the vapour inhalation studies by BASF AG (1979) and Atochem (contract lab: RCC, 1991) were considered to be the most reliable. They were well conducted according to or similar to OECD TG 403.

Sprague Dawley rats (10 animals/group/sex) were exposed to measured vapour concentrations of 0 (control), 1.08, 0.28, 0.17, 0.12, 0.11, and 0.09 (2x) mg/L for 4 hours. Animals died within 5 days after exposure. Surviving animals that had been exposed to 0.28 mg/L of the substance still showed symptoms after 14 days. Clinical signs of toxicity were: aqueous to red nose and eye discharge, eyelid closure, dyspnoea, apathy, reduced pain reaction, corneal opacity, scrubby and clotted coat, lurching and high stepping gait, flatulence and abdominal position. Necropsy findings of the deceased animals were acute dilatation and acute congested hyperemia of the heart, acute pulmonary emphysema, hyperemia with oedema in the lung, sporadic marginally dilated periphery of lobules in the liver (BASF AG 1979).

The acute inhalation toxicity LC50 was considered to be 0.22 mg/L (analytical, males and females). Exposure to 0.09 mg/L did not lead to lethalities (LC0 = 0.09 mg/L).

In two other vapour inhalation studies conducted by RCC for Atochem (1991) groups of Wistar rats were exposed to vapour concentrations of 0.512, 0.895 and 1.237 mg/L air (analytical) for 1 hour and to a saturated vapour of 0.352 mg/L air (analytical) for 4 hours, respectively. LC50 values were 1.342 mg/L for 1 hour (corresponding to 0.671 mg/L for 4 hours recalculated based on Haber’s law) and < 0.352 mg/L for 4 hours.

 

In another 4-hour inhalation study SD rats were exposed to aerosol concentrations of 0 (control), 0.037, 0.058, 0.092 and 0.460 mg/L for 4 hours.The acute inhalation toxicity LC50 was calculated to be 0.066 mg/L (liquid droplet aerosol). Minimal vascular congestion and areas of pulmonary oedema were found in lungs of the decedents. Due to lung weight to body weight ratio, it is assumed that the substance causes corrosion to the respiratory tract if inhaled, although no histopathological data are available. Due to the corrosive properties of the substance, lethalities cannot be related directly to the toxicity of 2-(dimethylamino)ethyl acrylate but have to be viewed in context with corrosivity.

 

Other exposure routes (intraperitoneal):

Regarding the acute toxicity by intraperitoneal administration, two values were reported for rats and for mice. The severer value was 183 mg/kg bw for rats (Rowell & Chiou, 1976). The intraperitoneal LD50 in mice was determined to be ca. 200 mg/kg (BASF AG, 1979).

 

Justification for classification or non-classification

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

- Oral route: Harmful if swallowed, R22

- Dermal route: Harmful in contact with skin, R21

- Inhalation route: Very toxic by inhalation, R26

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

- Oral route: Acute toxicity - Cat. 4

- Dermal route: Acute toxicity - Cat. 3

- Inhalation route: Acute toxicity - Cat. 1