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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:
weight of evidence
Study period:
5 March - 2 April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed and documented study anaolgue to "Inhalation Hazard Test" OECD guideline 403. No LC50 derivable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 403, 5. Annex: Inhalation Hazard Test
Deviations:
yes
Remarks:
nose-only exposure
GLP compliance:
not specified
Test type:
other: Inhalation Hazard Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
colorless, clear liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test Animals
- Body weight: males 163-178 g, females 177-194 g
- Diet: Altromin 1324, ad libitum
- Water: community tap water, ad libitum


Environmental Conditions
- Housing: Macrolon cages with softwood bedding
-Temperature: 20 - 22°C

Study period: 5. March - 2. April 1981

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
clean air
Details on inhalation exposure:
Each rat was placed in a plastic tube, which were connected to the inhalation chamber (20 L volume). Exposure was by nose exclusively. Ethylene glycol dimethyl ether was applied to a vaporizer and continuously evaporated. The resulting test substance/air mixture was carried to the inhalation chambers using an air stream of 600 L/h. Ethylene glycol dimethyl ether consupmtion was determined by weighing before study start and at study termination.
Inhalation was monitored by an automatic system. Temperature, pressure, CO, CO2 and O2 were measured continuously.

Temperature: 20 - 22.5°C
Pressure: 996 - 1004 mbar
Exposure duration: 1, 3 and 6 h
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by weighing substance container before and after exposure
Duration of exposure:
>= 1 - <= 6 h
Concentrations:
Group 1: 240 mg/L (1 hour), 6 males, 6 females
Group 2: 240 mg/L (3 hours), 6 males, 6 females
Group 3: 200 mg/L (6 hours), 6 males, 6 females
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopy
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC100
Effect level:
200 mg/L air
Exp. duration:
6 h
Remarks on result:
other: test substance saturated atmosphere
Sex:
male/female
Dose descriptor:
LC0
Effect level:
240 mg/L air
Exp. duration:
1 h
Remarks on result:
other: test substance saturated atmosphere
Mortality:
Group 1: 0/12 animals (1 h, 240 mg/L)
Group 2: 11/12 animals (3 h, 240 mg/L)
Group 3: 12/12 animals (6 h, 200 mg/L)
Clinical signs:
Group 1: Ataxia, salivation, irregular respiration; all symptoms were reversible within 24 hours
Group 2: Ataxia, anesthesia, disturbance of equilibrium, ventral position, tremor, absence of reflexes, piloerection, red colored lacrimation, irregular respiration, lens opacity
Group 3: Ataxia, anesthesia, disturbance of equilibrium, salivation, irregular respiration, lens opacity
Body weight:
Group 1: reduction of body weight on Day 1 to 6 after exposure, Days 7 to 14 regular body weight gain
Gross pathology:
Group 1: no effects
Group 2 (survivng animal): no effects
Groups 2 and 3 (dead animals): stomach filled with white foam
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information No LC50 derivable, substance was tested at excess concentration (saturated atmosphere) Criteria used for interpretation of results: expert judgment
Conclusions:
The LC0 of Ethylene glycol dimethyl ether after 1 h inhalation exposure is 240 mg/L.
The LC100 of Ethylene glycol dimethyl ether after 6h inhalation exposure is 200 mg/L.
Executive summary:

Three groups of 6 male and 6 female Wistar rats were exposed to a saturated Ethylene glycol dimethyl ether atmosphere at concentrations of 200 and 240 mg/L for 1 (group 1), 3 (group 2) and 6 (group 3) hours. All animals of group 1 (1 h, 240 mg/L) survived without irreversible clinical signs or macroscopic findings. Body weight was reduced during Day 1 to 6 after exposure. From Day 7 on the weight gain was regular (post exposure period: 14 days). In group 2 (3 h, 240 mg/L) 11 of 12 animals died and in group 3 (6 h, 200 mg/L) all animals died. Macroscopic abnormality observed in those animals which died was white foam in the stomach.