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Toxicological information

Acute Toxicity: inhalation

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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

Constituent 1
Chemical structure
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.

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