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EC number: 203-603-9 | CAS number: 108-65-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- dosing from GD 6-15 only - compared to current guideline with dosing from GD6-20
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-methoxy-1-methylethyl acetate
- EC Number:
- 203-603-9
- EC Name:
- 2-methoxy-1-methylethyl acetate
- Cas Number:
- 108-65-6
- Molecular formula:
- C6H12O3
- IUPAC Name:
- 2-methoxy-1-methylethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): PGMA
- Composition of test material, percentage of components: 97.3% of 2-methoxy-1-methylethyl acetate and 2.0 % of 1- methoxy-2- ) methylethyl acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- From Days 6 through 15 for 6 hours per day, pregnant rats were exposed either to PM Acetate vapor or room air. Vapors were generated by piping hot air through PM Acetate coated glass beads thus evaporating the liquid (reference 9). Chamber concentrations were measured three times a day at Hours 1, 3 and 5 by pumping chamber air to a MIRAN 80 Infrared Analyzer.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- days 6-15 of gestation
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- 21 days
- No. of animals per sex per dose:
- Main study: 23 pregnant rats in dose groups 0, 500, 2000 ppm; 20 pregnant rats in dose group 4000 ppm
(due to variable fertility) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Pregnant SD female rats were exposed to PGMA (purity: 97.3% of 2-methoxy-1-methylethyl acetate and 2.0 % of 1- methoxy-2- ) methylethyl acetate) vapour from Days 6 through 15 of gestation, once daily for 6 hours/day at nominal dose of 0, 500, 2,000, 4,000 ppm (0, 2700, 10800, 21600 mg/m3). The animals were sacrificed on Day 20 of gestation to evaluate the potential maternal, embryonic and teratogenic parameters of PGMA
Examinations
- Maternal examinations:
- Yes
- Ovaries and uterine content:
- Yes
- Fetal examinations:
- Yes
- Statistics:
- Yes
- Indices:
- Yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Most of the effects observed in dams were transient in nature. Reductions in muscle tone (2000 and 4000 ppm), food consumption (500, 2000 and 4000 ppm) and body weight (2000 and 4000) were seen during the exposure period. At 2000 and 4000 ppm exposure groups, dyspnea, ruffled pelt and red discharges from the eyes or mouth were observed. No toxic signs were observed in the 500 ppm exposure group. The effect on nasal cavity was not examined in this experiment.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 2 000 ppm
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No developmental toxicity was observed at any of the doses tested
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 000 ppm
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Pilot Study.
1.Ataxia was observed intermittently in several rats only in the 3000 ppm exposure group during exposure, but subsided soon after the rats were returned to their boxes.
2. Food consumption by dams as a percentage of body weight was lower in the 3000 ppm exposure group when compared to dams in the control group. This reduction coincided with the exposure period (Days 6 through 15) with the exception of the second and third exposure (Days 7 and 8). Food consumption returned to normal upon cessation of exposure. In the 1500 ppm exposure group, food consumption was lower only after the first exposure and in the 400 ppm exposure group it was never lower (data for the pilot study not shown herein).
3. Body weights, liver-to-body weight ratios and liver to brain weight ratios were not significantly different in any exposure group. There were no dose-related gross necropsy findings in the dams or fetuses.
Main Developmental Toxicity Study.
1.Group parameters. Group indexes, counts and other summary data for the study are presented without analysis in Table 1.
TABLE 1.GROUP PARAMETERS
PM Acetate Rat Inhalation Developmental Study
|
Control |
500 ppm |
2000 ppm |
4000 ppm |
Females mated |
25 |
25 |
25 |
25 |
Fatalities |
0 |
0 |
0 |
0 |
Females at sacrifice |
25 |
25 |
25 |
25 |
Females pregnant |
23 |
23 |
23 |
20 |
Fertility index (%) |
92 |
92 |
92 |
80 |
Litters |
23 |
23 |
23 |
20 |
Gestation Index (%) |
100 |
100 |
100 |
100 |
Implantations (total) |
333 |
330 |
320 |
278 |
Implantations per dam |
14.5 |
14.3 |
13.9 |
13.9 |
Fetuses (total) |
319 |
304 |
307 |
260 |
Fetuses per dam |
13.9 |
13.2 |
13.3 |
13.0 |
Index of alive fetuses (%) |
100 |
100 |
100 |
100 |
Dead Fetuses (total) |
0 |
0 |
0 |
0 |
Dead Fetuses per dam |
0 |
0 |
0 |
0 |
Resorptions (total) |
14 |
26 |
13 |
18 |
Early resorptions |
14 |
26 |
8 |
18 |
Late resorptions |
0 |
0 |
5 |
0 |
Resorptions per dam |
0.6 |
1.1 |
0.6 |
0.9 |
Resorption index (%) |
4.20 |
7.88 |
4.06 |
6.47 |
Malformations (total) |
0 |
1 |
1 |
0 |
Litters with Malformations |
0 |
1 |
1 |
0 |
Malformations per dam |
0 |
0.04 |
0.04 |
0 |
Index of malformations (%) |
0 |
0.33 |
0.33 |
0 |
Variations (total) |
17 |
19 |
16 |
11 |
Litters with Variations |
9 |
13 |
7 |
6 |
Variations per dam |
0.74 |
0.83 |
0.70 |
0.55 |
Index of variations (%) |
5.33 |
6.25 |
5.21 |
4.23 |
Runts |
0 |
0 |
2 |
3 |
Sex Ratio (M/F) |
1.10 |
0.90 |
0.99 |
1.08 |
2. Maternal parameters.
a. Toxic signs. Nearly half of the 20 dams in the 4000 ppm exposure group exhibited dyspnea at various times throughout the exposure period (Days 6 through 15). Breathing returned to normal soon after the dams were returned to their boxes. Half had red to reddish brown discharges from the nose and/or eyes on Days 8 and 10 through 15. Four dams were observed to have yellow staining in the fur of the urogenital area ranging from slight to marked on Days 6, 8, 13 and 14. Reduced muscle tone was observed during handling in 15 dams on two separate occasions. Movement returned to normal within 20 minutes of being returned to their boxes. In the 2000 ppm exposure group, one dam exhibited dyspnea, one had a ruffled pelt and two had red discharges from the eye or mouth. No toxic signs were observed in the 500 ppm exposure group.
b. Food consumption. In the 4000 ppm exposure group, a reduction of food consumption as a percentage of maternal body weight coincided with exposure to PM Acetate. A similar pattern was seen in the 2000 ppm exposure group where food consumption was lower on Days 7, Days11 through 13 and Day 15. In the 500 ppm exposure group, food consumption was lower on Days 7 and11
c. Maternal body weights and body weight gains. Maternal body weights were lower in the 4000 and 2000 ppm exposure group after the last day of exposure only. Maternal body weights in the 500 ppm exposure group were always the same as controls.However, when weight gains were analyzed, dams in the 4000 ppm exposure group did not gain as much as controls during the exposure period and gained less overall. Dams in the 2000 ppm exposure group gained less weight during the first two thirds of the exposure period and less overall also Dams in the 500 ppm exposure group gained weight at the same rate as dams in the control group.
d.Maternal organ weight ratios. There were no differences in relative liver or uterus weights between dams in the control group and dams in any exposure group whether ratios were calculated from body weights or brain weights.
3.Litter and Fetal Parameters.
a. Corpora lutea, implantation, litter size, resorption and fetal death. The number of corpora lutea, implantation sites and live fetuses per litter was the same in the exposed groups as controls. Both the percent of conceptuses resorbed per litter and the percent of litters which contained a resorption were the same in the exposed groups as the controls. There were no dead fetuses in any litter.
b. Fetal body weights and runts. There were no dose related differences in fetal body weights. The average fetal body weights in the 4000 and 2000 ppm exposure groups was approximately 5 percent lower than the low and controls. This difference was statistically significant in the 2000 ppm exposure group, however, the 4000 ppm exposure group was marginally nonsignificant. There was no difference in the percent of litters which contained runts.
c. Fetal sex ratio. There was no difference in the male to female sex ratio.
d. Malformations and variations. There were no differences in the percent of fetuses per litter that were malformed, had variations or were normal. In addition, there were no differences in the percent of litters which contained a malformation, a variation or contained all normal fetuses.
Applicant's summary and conclusion
- Conclusions:
- A NOAEC was established at 500 ppm (2700 mg/m3 measured) for dams and 4,000 ppm (22464 mg/m3, measured) for foetuses.
- Executive summary:
In a GLP study, pregnant SD female rats were exposed to PGMA (purity: 97.3% of 2-methoxy-1-methylethyl acetate and 2.0 % of 1- methoxy-2- ) methylethyl acetate) vapour from Days 6 through 15 of gestation, once daily for 6 hours/day at nominal dose of 0, 500, 2,000, 4,000 ppm (0, 2700, 10800, 21600 mg/m3). The animals were sacrificed on Day 20 of gestation to evaluate the potential maternal, embryonic and teratogenic parameters of PGMA. Most of the effects observed in dams were transient in nature. Reductions in muscle tone (2000 and 4000 ppm), food consumption (500, 2000 and 4000 ppm) and body weight (2000 and 4000) were seen during the exposure period. At 2000 and 4000 ppm exposure groups, dyspnea, ruffled pelt and red discharges from the eyes or mouth were observed. No toxic signs were observed in the 500 ppm exposure group. The effect on nasal cavity was not examined in this experiment. No developmental toxicity was observed. A NOAEC was established at 500 ppm (2700 mg/m3, measured) for dams and 4000 ppm (22464 mg/m3, measured) for foetuses
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