Propane-1,2-diol

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Expert panel report, published by a reliable scientific institution, contributing to the assessment.

Data source

Reference

Reference Type:

publication

Title:

1,2-dihydroxypropanol

Author:

Sponsor country: USA

Year:

2001

Bibliographic source:

SIDS Initial Assessment Report for 11th SIAM (USA, January 23-26, 2001)

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,2-diol

Results and discussion

Any other information on results incl. tables

SUMMARY CONCLUSIONS OF THE SIAR

Human Health

Monopropylene glycol is not acutely toxic. The lowest oral LD50 values range between 18 and 23.9 grams (5 different species) and the reported dermal LD50 is 20.8 grams. Monopropylene glycol is essentially nonirritating to the skin and mildly irritating to the eyes. Numerous studies support that monopropylene glycol is not a skin sensitizer. Repeated exposures of rats to propylene glycol in drinking water or feed did not result in adverse effects at levels up to 10% in water (estimated at about 10 g/kg bw/day) or 5% in feed (dosage reported as 2.5 g/kg bw/day) for periods up to 2 years. In cats, two studies of at least 90 days duration show that a species-specific effect of increased Heinz bodies was observed (NOAEL = 80 mg/kg bw/day; LOAEL = 443 mg/kg bw/day), with other haematological effects (decrease in number of erythrocytes and erythrocyte survival) reported at higher doses (6-12% in diet, or3.7-10.1 g/cat/day).

Monopropylene glycol did not cause fetal or developmental toxicity in rats, mice, rabbits, or hamsters (NOAELs range from 1.2 to 1.6 g/kg bw/day in four species). No reproductive effects were found when monopropylene glycol was administered at up to 5% in the drinking water (reported as 10.1 g/kg bw/day) of mice. Monopropylene glycol was not a genetic toxicant as demonstrated by a battery of in vivo (micronucleus, dominant lethal, chromosome aberration) and in vitro (bacterial and mammalian cells and cultures) studies. No increase in tumors was found in all tissues examined when propylene glycol was administered in the diet of rats (2.5 g/kg bw/day for 2 years), or applied to the skin of female rats (100% monopropylene glycol; total dose not reported; 14 months) or mice (mouse dose estimated at about 2 g/kg bw/week; lifetime). These data support a lack of carcinogenicity for monopropylene glycol.

Environment

Monopropylene glycol is not volatile, but is miscible with water. Air monitoring data are not available, but concentrations of monopropylene glycol in the atmosphere are expected to be extremely low because of its low vapor pressure and high water solubility. It is readily biodegraded in water or soil. Four studies reported >60% biodegradation in water in 10 days. Monopropylene glycol is not expected to bioaccumulate, with a calculated BCF <1. Measured freshwater aquatic toxicity data for fish, daphnia and algae report LC/EC50 values of >18,000 mg/l. Therefore, monopropylene glycol is not acutely toxic to aquatic organisms except at

very high concentrations. Using an assessment factor of 100 and the Ceriodaphnia data (48- hour EC 50 = 18,340 mg/l), the PNEC is 183 mg/l.

NATURE OF FURTHER WORK RECOMMENDED

No further work is recommended.