Propylene glycol monomethyl ether acetate was studied for oral toxicity in rats in an OECD combined repeat dose and reproductive/developmental toxicity screening test at doses of 0, 100, 300 and 1000 mg/kg/day.
With regard to repeat dose toxicity, a dose of 1000 mg/kg of the test substance exerted toxic effects in both male and female rats. In males, depression of body weight gain and a tendency for decrease in food consumption were observed. Blood chemical examination revealed decreases in glucose and inorganic phosphorus. An increase in relative weight of the adrenals was also noted. In females, body weight gain was lower than in the control during the premating period. The NOEL for repeat dose toxicity is considered to be 300 mg/kg/day for both sexes.
In terms of reproductive and developmental toxicity, the test substance showed no effects on any relevant parameters. The NOEL for both reproductive performance and offspring development is considered to be 1000 mg/kg/day.
Propylene glycol monomethyl ether acetate was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.
Genotoxicity of propylene glycol monomethyl ether acetate was studied by the chromosomal aberration test in cultured Chinese hamster lung(CHL/IU)cells.
Propylene glycol monomethyl ether acetate did not induce structural chromosomal aberrations and polyploidy up to the maximum concentration of 1.3 mg/mL(10 mM), on continuous treatment, and on short-term treatment with and without an exogenous metabolic activation system.
| Purity | : | 99.9 % |
| Test species/strain | : | Rat/Crj:CD(SD) |
| Test method | : | OECD Combined Repeat Dose and Reproductive/ Developmental Toxicity Screening Test |
| Route | : | Oral(gavage) |
| Doses | : | 0(vehicle), 100, 300, 1000 mg/kg/day |
| Number of animals/group | : | Males, 10; females, 10 |
| Vehicle | : | Purified water |
| Administration period | : | Males, 44 days Females, from 14 days before mating to day 3 of lactaion |
| Terminal kill | : | Males, 45 days Females, day 4 of lactation |
| GLP | : | Yes |
Test results:
The test substance at doses of 100 and 300 mg/kg did not exert any toxic effects on general condition, body weights, food consumption, urinalysis, hematology, blood chemistry, necropsy, organ weights and histopathology.
With a dose of 1000 mg/kg, in males, there was a depression of body weight gain and a tendency for decrease in food consumption was observed. Blood chemical examination revealed decreases in glucose and inorganic phosphorus. An increase in relative weight of the adrenals was also noted.
In females, body weight gain was lower than in the controls during the premating period.
The NOEL for repeat dose toxicity is considered to be 300 mg/kg/day for both sexes.
<Reproductive and developmental toxicity>
The test substance did not exert any toxic effects on reproductive parameters including the copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, delivery index and behavior at delivery and lactation.
There were no differences between dosed groups and control group in offspring parameters including numbers of offspring or live offspring, sex ratio, live birth index, viability index and body weights. No external or visceral abnormalities related to the test substance were detected in any of the offspring.
The NOEL for reproductive performance of the parents and offspring development is considered to be both 1000 mg/kg/day.
| Purity | : | > 99.9 % |
| Test species/strains | : | Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA |
| Test method | : | Guidelines for Screening Toxicity Testing of Chemicals (Japan) and OECD Guidelines No. 471 and 472 |
| Procedures | : | Pre-incubation method |
| Solvent | : | Distilled water |
| Positive controls | : | -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide(TA100, TA98, WP2 uvrA), Sodium azide(TA1535)and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(five strains) |
| Doses | : | -S9 mix; 0, 313, 625, 1250, 2500, 5000 μg/plate(five strains) +S9 mix; 0, 313 - 5000 μg/plate(five strains) |
| S9 | : | Rat liver, induced with phenobarbital and 5,6-benzoflavone |
| Plates/test | : | 3 |
| Number of replicates | : | 2 |
| GLP | : | Yes |
Test results:
Genetic effects:
Salmonella typhimurium TA100, TA1535, TA98, TA1537
| + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] |
Escherichia coli WP2 uvrA
| + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] |
| Purity | : | > 99.9 % |
| Type of cell used | : | Chinese hamster lung(CHL/IU)cells |
| Test method | : | Guidelines for Screening Mutagenicity Testing of Chemicals(Japan)and OECD Guideline No. 473 |
| Solvent | : | Distilled water |
| Positive controls | : | -S9 mix, Mitomycin C +S9 mix, Cyclophosphamide |
| Doses | : | -S9 mix(continuous treatment): 0, 0.33, 0.65, 1.3 mg/mL -S9 mix(short-term treatment): 0, 0.33, 0.65, 1.3 mg/mL +S9 mix(short-term treatment): 0, 0.33, 0.65, 1.3 mg/mL |
| S9 | : | Rat liver, induced with phenobarbital and 5,6-benzoflavone |
| Plates/test | : | 2 |
| GLP | : | Yes |
Test results:
Genotoxic effects:
| clastogenicity | polyploidy | |||||
| + | ? | - | + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] | [ ] | [ ] | [*] |
| 1) | The tests were performed by the Research Institute for Animal Science in Biochemistry and Toxicology, 3-7-11 Hashimotodai, Sagamihara-shi, Kanagawa 229-1132, Japan. Tel +81-42-762-2775 Fax +81-42-762-7979 |
| 2) | The tests were performed by the Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano-shi, Kanagawa, 257-0025, Japan. Tel +81-463-82-4751 Fax +81-463-82-9627 |