Glycerol, ethoxylated, esters with acrylic acid

Endpoint summary

Description of key information

Skin 
In vitro: not corrosive (BASF SE, 2010)
In vivo:
- Rabbit, 4 h, semiocclusive: not irritating to skin (acc. OECD 404, BASF AG 2004)
- Rabbit, 4 h, semiocclusive: not irritating to skin (acc. OECD 404, Huntingdon 1999)
Eye
In vivo:
- Rabbit, 24 h, substance was not washed out: risk for serious damage to eyes (acc. OECD 405, BASF AG 2004)
Respiratory system
- Rat, acute inhalation of a test substance aerosol: irritating to the respiratory tract (acc. OECD 403, BASF SE 2010)

Additional information

There are valid in vitro and in vivo data available for the assessment of the skin, eye and respiratory tract irritation potential of Glycerol, ethoxylated, esters with acrylic acid.

 

Skin

In vitro testing in the EpiDerm™ skin corrosion test according to OECD 431 guideline showed that the test substance is not corrosive (BASF SE, 2010).

In-vivo, a skin irritation test was performed with three New Zealand White rabbits, according to OECD guideline 404 (BASF AG 2004, Val. 1). A 4-hour semiocclusive exposure to ca. 0.5 ml of the undiluted test substance produced the following effects: For erythema, a score of 2 was observed directly after patch removal and one hour thereafter in all three animals. At later reading time points (48 and 72 h) the score was 0. For erythema the score was 0 at all reading time points.

In a further in-vivo study, according to OECD guideline 404 the test material caused irritating effects on the skin of 1 out of 3 New Zealand White rabbits, as the mean value for erythema formation was 2 and 1.67 for edema formation. Desquamation was observed from d6 to end of observation period and was characterized by dryness and sloughing (acc. OECD 404, Huntingdon 1999). The effects observed were fully reversible within at least 8 days. In animal 2 and 3 no effects were observed at any reading time point.

 

Eye

An eye irritation test was performed with 1 New Zealand White rabbit, according to OECD guideline 405 (BASF AG 2004, Val. 1).The eye was left unwashed after application of 0.1 ml of the test material and the animal was observed for 28 days. At the 1h reading, the index for corneal opacity, area and iris could not be read because of severe swelling. Also at the 24h reading, the index for Iris and area could not be read because of severe swelling. The mean score (reading time points 24-48-72 h) for cornea was 2, for iritis 2, for conjunctiva redness 3, and 3.3 for conjunctiva chemosis. The effects on cornea opacity were not reversible within the observation period of 28 days, all other effects were fully reversible within this time period.

 

Respiratory system

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). In this study a satellite group of animals was exposed to 0.051 mg/L (analytical concentration) and after sacrifice subjected to gross and histopathological examination. The following organs were fixated in 4% buffered formaldehyde, processed histotechnically and examined by light microscopy: head, larynx, pharynx, lungs, tracheobronchial, mediastinal and mesenteric lymph nodes, and the nasal cavity.

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 severe 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.

Based on these findings,Glycerol, ethoxylated, esters with acrylic acid has to be regarded as an irritant to the respiratory tract.

Justification for classification or non-classification

Skin

Glycerol, ethoxylated, esters with acrylic acid has not to be classified as skin irritant according to EU-criteria or GHS-criteria.

 

Eye

Severe eye irritation effects were observed on corneal opacity, iritis, conjunctival redness and chemosis. Therefore, Glycerol, ethoxylated, esters with acrylic acid has to be classified as eye irritant according to EU-criteria (R41) and GHS-criteria (category 1).

 

Respiratory system

Severe irritation of the upper respiratory tract was observed in rats which had been exposed for 4 hrs to a liquid aerosol of the substance. Therefore, Glycerol, ethoxylated, esters with acrylic acid has to be classified as respiratory tract irritant according to EU-criteria (R37) and GHS-criteria (STOT SE category 3).

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: Xi, R37, 41
• GHS classification (REGULATION (EC) No 1272/2008 (CLP)): Eye irritation category 1, Specific target organ toxicity single exposure category 3 (irritating to the respiratory tract)