Glycerol, ethoxylated, esters with acrylic acid

Endpoint summary

Description of key information

Oral
Rat: LD50 >300 and  <2000 mg/kg bw (comp. OECD 401; BASF AG 2005)
Inhalation
Rat: LC50 = 0.541 mg/L (accord. OECD 403, aerosol; BASF SE 2010)
Dermal
There are no data available.

Additional information

There are valid data available for the assessment of the acute toxicity of Glycerol, ethoxylated, esters with acrylic acid by the oral and inhalation route.

 

Oral

In an acute toxicity test, according to OECD guideline 423, 3 females received 2000 mg/kg bw and 6 females received 300 mg/kg bw Glycerol, ethoxylated, esters with acrylic acid under standardized conditions (BASF AG, 2005). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 is >300 and <2000 mg/kg bw for female rats. None of the females in the 300 mg/kg bw dose group died during the observation period, but 3/3 animals of the 2000 mg/kg bw died within the first two days. No clinical observations were observed during clinical examination in the 300 mg/kg bw administration group. Clinical observations in the 2000 mg/kg bw administration group revealed poor general state, dyspnoea, staggering and piloerection and were observed in two females one day after administration. The mean body weights of the administration groups increased throughout the study period. At gross necropsy, moderate or severe, (red) hyperemia in the glandular stomach (3 females) and slight, red discoloration of contents of the small intestine (1 female) was seen in the animals that died during the study (2000 mg/kg bw), as well as black discoloration of contents of the small intestine (1 female). No macroscopic pathologic abnormalities were noted at termination of the study in the surviving animals (300 mg/kg bw).

 

Inhalation

To determine the acute inhalation toxicity (single 4-hour exposure, head-nose only) of Glycerin 3EOTA as a liquid aerosol, a GLP-compliant study in male and female Wistar rats was performed according to OECD TG 403 (BASF SE, 2010). The following measured concentrations were tested: 0.051, 0.213 and 0.996 mg/L (analytical concentration). Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) between 2.0 and 3.5 μm, which are well within the respirable range.

No mortality occurred at 0.051 mg/L. One of five males and no females died at 0.213 mg/L. Three of five males and all of the female animals died at 0.996 mg/L. Clinical signs of toxicity in animals exposed to 0.051 mg/L comprised accelerated respiration, abdominal respiration, colourless discharge of the nose and piloerection. The animals exposed to 0.213 mg/L showed in addition to the already described symptoms respiration sounds, red discharge and encrusted nose, colorless discharge of the eye, a distended abdomen, and substance contaminated fur. In the animals exposed to 0.996 mg/L the following findings were seen additionally: laboured respiration, gasping, hunched posture, and poor general state.

The mean body weights of the animals in the low and mid dose group decreased during the first few post exposure observation days and increased from study day 3 and study day 7 onward, respectively. The mean body weights of the surviving male animals of the high dose group decreased during the first post exposure observation week but increased during the second week. However, the body weight of the surviving male animals did not reach the initial level.

During necropsy of the two male and three female animals of the high dose group that were found dead during or after exposure on study day 0, no gross pathological abnormalities were noted. The male animal that was found dead on study day 1 showed focal red discoloration of the lung with partly sunken surface. Necropsy findings of the male and female animal that died on study day 3 comprised only in the female animal several red foci in all lung lobes and slight dilation with a gaseous content of the stomach and jejunum. The male animal showed no gross pathological abnormalities. During the necropsy at study termination the male animal showed few red foci of all lung lobes, the remaining female animal showed no gross pathological abnormalities.

During necropsy of the one male animal of the mid dose group that was found dead on study day 1, dark-red discoloration of the lung was noted. Few red foci in the pulmo sinister were noted during necropsy in the one male animal at study termination. The remaining animals showed no gross pathological abnormalities during the necropsy at study termination.

Gross pathology of the satellite group animals exposed to 0.541 mg/L showed no macroscopic findings in all animals of the satellite group. Histopathological examination revealed in the nasal cavity severe focal ulceration (3/3 animals at level I; 2/3 animals at level II) and/or inflammation (1/3 animals at level II) of squamous epithelium localized at the base of the nasal cavity. These findings that are indicative of irritation of the upper respiratory tract were regarded as adverse and most likely the reason for lethality. Additionally, the larynx at level I showed slight epithelial alteration at the base of the epiglottis. This finding was regarded as non-adverse, but adaptive.

Thus, the observed deaths were most probably due to local irritation effects in the respiratory tract.

 

Under the conditions of this study the LC50 for male and female rats after liquid aerosol inhalation exposure of Glycerin 3EOTA was estimated to be 0.541 mg/L (analytical concentration).

 

Dermal

There are no data available.

Justification for classification or non-classification

The available data for Glycerol, ethoxylated, esters with acrylic acid indicate a potential for acute toxicity.

In a reliable study, the oral LD50 was > 300 and < 2000 mg/kg bw for female rats. Therefore, Glycerol, ethoxylated, esters with acrylic acid has to be classified according to EU (Xn R22) and GHS (Category 4) requirements in this endpoint.

In an acute inhalation study conducted with a liquid aerosol of the substance, the LC50 was determined to be 0.541 mg/L in female and male rats. Therefore, Glycerol, ethoxylated, esters with acrylic acid has to be classified according to EU (T R23) and GHS (Category 3) requirements in this endpoint.

Thus, based on the available data, classification of the substance concerning acute toxicity is warranted:

• EU classification according to Annex VI of Directive 67/548/EEC: T, R22, 23
• GHS classification (REGULATION (EC) No 1272/2008 (CLP)): Acute oral toxicity Category 4, Acute inhalation toxicity (mist) Category 3