Propane-1,2-diol, propoxylated

Endpoint summary

Description of key information

Acute toxicity of MPG, propoxylated via oral route were determined to be >2000 and >5000 mg/kg body weight in two studies and in the dermal study was determined to be >3000 mg/kg body weight.
Tetrapropylene Glycol, a major component of PPG, has been tested for acute oral and dermal toxicity in male rats. Although the tests were not conducted according to a guideline or GLPs, adequate information was available to determine that the tests and resulting data were reliable. There was no mortality for either test. The estimated values for acute oral LD50 and dermal LD50 for Tetrapropylene Glycol in rats are >2000 mg/kg bw.  
Tetrapropylene Glycol Crude (also known as Tripropylene Glycol Bottoms), representative of PPG/PG Highers composition with significant proportion of tetrapropylene glycol and tripropylene glycol, has been tested for acute oral toxicity and acute inhalation toxicity in male rats, and for acute dermal toxicity in female rabbits. Although these tests were not conducted according to a guideline or GLPs, adequate information was available to determine that these tests and the resulting data are reliable. There was no mortality for either the oral or the dermal test. The estimated values for acute oral LD50 and acute dermal LD50 for Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) in rats are >2000 mg/kg bw.The acute inhalation toxicity of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) in rats was evaluated with a 1-h exposure (whole body); there was no mortality in the 2-week observation period. The acute inhalation LD50 (1-h) is >0.17 mg/L, which was calculated based on weight of test material.

Additional information

Acute toxicity of MPG, propoxylated via oral route were determined in two studies. In an OECD 423 (Class method) LD50 was found > 2000 mg/kg bw and in a study similar to OECD 401the LD50 was > 5000 mg/kg bw. Acute toxicity via the dermal route was determined to be > 3000 mg/kg bw.

Tetrapropylene Glycol, a major component of PPG, has been tested for acute oral and dermal toxicity in male rats (Dow, 1996). Although the tests were not conducted according to a guideline or GLPs, adequate information was available to determine that these tests were reliable.All clinical signs noted following oral gavage administration were resolved by day 3 post-dosing, and all rats gained weight; there was no mortality. The estimated acute oral LD50for Tetrapropylene Glycolis >2000 mg/kg bw. The acute dermal toxicity tests conducted in 2 female rabbits, included dosing with 2000 mg/kg bw for 24-h at a clipped dorsal site, which was covered with an elastic rabbit jacket. No clinical observations or systemic toxicity were reported and body weight (days 1, 2, 8, and 15) was increased over the 2-week observation period. The dosing site exhibited erythema and/or edema, with scaling identified for one rabbit, but all irritation and scaling was resolved by the end of the 2-week observation period. There was no mortality. Based on these results, the acute dermal LD50 value for Tetrapropylene Glycol in rabbits is >2000 mg/kg bw.

 

Tetrapropylene Glycol Crude (also known as Tripropylene Glycol Bottoms) has been tested for acute oral toxicity and acute inhalation toxicity in male rats, and for acute dermal toxicity in female rabbits (Dow, 1984). Although these tests were not conducted according to a guideline or GLPs, adequate information was available to determine that these tests and the resulting data are reliable.The acute oral toxicity, which included 3 dose levels with 4 rats each, was conducted over a 14-d period with observations and collection of body weights, and a gross necropsy. Clinical signs noted over 2 days following oral gavage administration of 2000 and 1000 mg/kg levels (tremors, lethargy, and diarrhea) were resolved and all rats, including the 500 mg/kg bw group, gained weight and appeared healthy during the remainder of the 2-week observation period. There was no mortality.The estimated acute oral LD50 for Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) in rats is >2000 mg/kg bw.

The acute dermal toxicity of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) was investigated in two female rabbits treated with 2000 mg/kg bw of the test material in an acute percutaneous absorption test. Animals were observed closely the day of treatment then periodically for the 2-week observation period. Both rabbits remained healthy and gained weight during the 2-week observation period; there was no mortality prior to scheduled sacrifice. Gross necropsy examination after two weeks post-dosing did not identify any lesions attributable to treatment.Under the testing conditions of this study, the acute dermal LD50 of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) is >2000 mg/kg bw in female rabbits. 

The acute inhalation toxicity of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) was evaluated with a 1-h exposure (whole body) of 4 rats to saturated vapor (room temperature). There were no clinical signs observed throughout the 2-week observation period; all rats gained weight and there was no mortality prior to scheduled sacrifice. Gross necropsy did not identify any lesions attributable to test material. Based on the difference in weight of test material before and after exposure, the acute inhalation LC50 (1-h) for Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) is >0.17 mg/L. 

 

Thus bothTetrapropylene Glycol andTetrapropylene Glycol Crude (Tripropylene Glycol Bottoms)haveacute oral LD50 values >2000 mg/kg bw and acute dermal LD50 values >2000 mg/kg bw; Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) has an acute inhalation LC50 value >0.17 mg/L.

Justification for classification or non-classification

LD50 values for MPG, propoxylated for oral and dermal route > 2000 mg/kg/bw do not warrant classification according to the relevant criteria in the EU.

Based on the acute oral and acute dermal LD50 values of >2000 mg/kg bw, for both Tetrapropylene Glycol andTetrapropylene Glycol Crude (Tripropylene Glycol Bottoms), classification is not warranted for either in accordance with Directive 67/548/EEC and EU Classification, Labelling, and Packaging of Substances and Mixtures (CLP) Regulation (EC)No. 1272/2008. For acute inhalation Toxicity ofTetrapropylene Glycol Crude (Tripropylene Glycol Bottoms), the LC50 value of >0.17 mg/L (1-h) was obtained,which is below the cut-off value of 20 mg/L/4 h established for classification of vapors. However, as this exposure corresponded to the saturated vapor concentration at room temperature, and based on the absence of mortality and of any clinical signs of toxicity in the study, the classification ofTetrapropylene Glycol Crude (Tripropylene Glycol Bottoms)for acute inhalation toxicity is not warranted in accordance to Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.