Registration Dossier

Administrative data

Description of key information

The test item is considered to possess no skin or eye irritating properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

In a study conducted according to Draize, rabbits received occlusive skin applications of the undiluted test material diethylene glycol for 23 hours (Guillot et al., 1982). No skin reactions were noticed. When tested on human volunteers under occluded conditions (human occluded patch test; Monsanto, 1970), diethylene glycol was found to be a mild irritant and the slight skin findings were fully reversible within less than 24 hours.

 

Diethylene glycol was further tested in a reconstructed human epidermal model EpiDerm TM, according to OECD Guideline 439 (BASF, 2016). The objective of this in vitro method is to assess the skin irritation potential of the test substance. Available information on toxicological and physico-chemical properties of the test substance2,2'-oxydiethanol including considerations concerning structure-activity-relationships did not indicate an irritation potential of the substance. Thus, the EpiDerm™ Skin irritation test was performed. The test substance was topically exposed to the surface of a human reconstituted epidermis model for 1 hour followed by a cell viability test. The optical density of the extracts of the test substance treated tissue was compared to negative control values from treated tissue with PBS and is expressed as relative tissue viability. The relative tissues viability was 94.5 % and therefore 2,2'-oxydiethanol was clearly not irritant.

 

Eye irritation

Carpenter and Smyth (1946) tested diethylene glycol for eye irritation and applied 0.5 mL of undiluted test item into the eyes of rabbits; readings of the treated eyes revealed no signs of ocular irritation due to the treatment with 0.5 mL of undiluted test item. In a more recent publication by Guillot et al. (1982), the irritating potential of diethylene glycol to the eye was evaluated by application of 0.1 mL of test item at test concentrations ranging from 10 to 100%, into the eye of 6 male albino rabbits. Reading of the treated eyes was done after 1 h, 24 h, 2 days, 3 days, 4 days and 7 days following application. The findings were evaluated using the evaluation scale of 0 to 110 by Kay and Calandra (J Soc Cosmet Chem 13: 281–289, 1962, modified). The test item resulted in a mean ocular index of 11.67 which was below 15, and there was no indication for corneal opacity. Thus, the test item was not irritating to the eye of rabbit under the test conditions used.

 

Respiratory irritation

No animal study is available.

 

To determine whether an atmosphere containing aerosolized ethylene glycol in a concentration that could be tolerated by human volunteers for most of each 24-h period would have any deleterious action on man, in a prison hospital twenty volunteers were exposed during 20 to 22 h per day to aerosolized ethylene glycol in mean daily concentrations between 3 and 67 mg/m3 (Wills, 1974; please also refer to section "Exposure related observations in humans" - IUCLID chapter 7.10).

Nineteen men finished the planned one-month exposure. When the concentration of ethylene glycol within the chamber was raised to 200 or more mg/m3, the atmosphere could not be tolerated for more than a minute or two, the period of tolerance decreasing progressively as the concentration was increased further. Blood and urine specimens obtained from the volunteers at intervals during their prolonged exposure gave little evidence of the absorption of important quantities of ethylene glycol. No subject experienced any serious signs of toxicity assignable to the exposure, but there were complaints of irritation of the throat and fauces. Slight headache and low backache also were reported occasionally. The irritative phenomena became common when the concentration of ethylene glycol in the ambient air was raised to about 140 mg/m3. The irritative effects appear to rule out the possibility that a harmful amount of ethylene glycol could be absorbed from the respiratory tract of a healthy Individual who was unaware that he had been exposed to this substance.

Justification for classification or non-classification

Based on the available information classification for skin, eye and respiratory irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.