2-methoxy-1-methylethyl acetate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The GLP-study contains sufficient information to permit a meaningful evaluation of study results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The study was designed to evaluate the species dependent differences between rats and mice in respiration during Propylene glycol monomethyl ether acetate exposure

GLP compliance:

yes

Test type:

other:

Limit test:

no

Test material

Test material information

Constituent 1

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): Propylene Glycol Monomethyl Ether Acetate
- Physical state: liquid
- Analytical purity: 99.2%
- Impurities (identity and concentrations): Propylene glycol monomethyl ether (0.13%)
- Composition of test material, percentage of components: Propylene Glycol Monomethyl Ether Acetate (>95% secondary isomer)
- Isomers composition: as described above
- Purity test date: not specified in the report
- Lot/batch No.: #MM840531
- Expiration date of the lot/batch: not specified in the report
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Weight at study initiation: approximately 220 g
- Fasting period before study: not specified in the report
- Housing: not specified in the report
- Diet (e.g. ad libitum): Purina certified Rodent Chow #5002 provided ad libitum, except during exposure
- Water (e.g. ad libitum): water provided ad libitum, except during exposure
- Acclimation period: 1-2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 °F
- Humidity (%): 50%
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): not specified in the report

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

The exposure device used accomodated up to 4 rats and was primarily made of Teflon and stainless steel. Test atmospheres were generated by pumping from pre-conditioned Saran bags containing the desired concentration of Propylene glycol monomethyl ether acetate at approximately 50%. Airflow was set at 400 ml/minute.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Test atmospheres were analyzed by gas chromatography (Varian 2400) with a flame ionization detector. A 6' by 1/8" column packed with 8% Triton X-305 on chromosorb W-HP was used at a column temperature of 70 °F

Duration of exposure:

3 h

Concentrations:

0, 300, 1000, 2000 ppm (0, 1.62, 5.39, 10.8 mg/l)

No. of animals per sex per dose:

4 male rats/dose

Control animals:

yes

Details on study design:

Head only exposure was performed by a device that accomodated up to 4 rats and was primarily made of Teflon and stainless steel. Test atmosphere from preconditioned Saran bags containing the desired concentration were pumped with an airflow of 400 ml/min. Test atmosphere was analysed by gas chromatography.

Respiratory frequency, tidal volume and minute volume were measured at one minute intervals before (10 minutes) during (first 20 minutes) and after 1, 2 and 3 hours of exposure. The head-only exposure device input and exhaust concentrations were determined by gas chromatography and were used to calculate uptake.

Statistics:

Standard statistical methods were used

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC0

Effect level:

> 2 000 ppm

Exp. duration:

3 h

Mortality:

Mortality data was not reported.

Clinical signs:

other: Not specified in the report

Body weight:

Not specified in the report

Gross pathology:

No histological effects in any rats except in the nasal mucosa in one of the four animals of the 2000 ppm group. A slight degree of of degeneration and flattening of the olfactory epithelium was detected in one side of the nasal cavity.

Other findings:

Respiratory frequency and minute volume were reduced in a concentration dependent manner. Uptake rates remained unchanged after 1 , 2 and 3 hours of exposure

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Fischer 344 rats were exposed head only at a Propylene Glycol Monomethyl Ether Acetate (purity unknown) concentrations of 0 – 300 (1,620 mg/m3) and 2,000 ppm (10,800 mg/m3) during 3 hours. Respiratory frequency was reduced in rats exposed to 2,000 ppm (10,800 mg/m3). Mortality data was not reported.

Executive summary:

Fischer 344 rats were exposed head only to propylene glycol monomethyl ether acetate concentrations of 0 – 300 (1,620 mg/m³) and 2,000 ppm (10,800 mg/m³) during 3 hours. Respiratory frequency was reduced in rats exposed to 2,000 ppm (10,800 mg/m³). Mortality data were not reported.