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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 July - 14 July 1979
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:
1979
Report Date:
1979

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:
no
Remarks:
study performed before GLP guidelines
Test type:
other: Inhalation Hazard Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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
- Weight at study initiation: males 234-250g, females 200-220g

- Housing:
- Diet (e.g. ad libitum): 1324, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Housing: Macrolon cages with softwood bedding
- Temperature (°C): 22°C


IN-LIFE DATES: From: To: 10. july - 24. July 1979

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. Diethylene 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. Diethylene glycol dimethyl ether consupmtion was determined by weighing before study start and at study termination.

Temperature: 21.9 - 22.0°C
Pressure: 1010 mbar
Exposure duration: 7 h
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
7 h
Concentrations:
11.1 mg/L (7 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: clinical - daily, weighing - weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopy
Statistics:
none

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
11 mg/L air
Exp. duration:
7 h
Remarks on result:
other: test substance saturated atmosphere
Mortality:
0/12 animals (7 h, 11 mg/L)
Clinical signs:
No effects
Body weight:
No effects
Gross pathology:
No effects
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information LC0: 11 mg/L for 7 h Criteria used for interpretation of results: expert judgment
Conclusions:
The LC0 of Diethylene glycol dimethyl ether after 7 h inhalation exposure is 11 mg/L.
Executive summary:

Triethylene glycol dimethyl ether and Diethylene glycol dimethyl ether, which is tested for its inhalation toxicity, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Triethylene glycol dimethyl ether and Diethylene glycol dimethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):

1. Triethylene glycol dimethyl ether:H3C-O-CH2-CH2-O-CH2 -CH2 -O-CH2 -CH2-O-CH3

2. Diethylene glycol dimethyl ether:H3C-O-CH2-CH2-O-CH2-CH2-O-CH3

the same mode of interaction with bio-macromolecules, living cells and tissue and metabolic pathway is expected. Furthermore, it can be shown that Ethylene glycol dimethyl ether, Diethylene glycol dimethyl ether and Triethylene glycol dimethyl are are not acute orally toxic and neither Ethylene glycol dimethyl ether nor Diethylene glycol dimethyl ether was found to be acute toxic by inhalation. Therefore, a read-across from Triethylene glycol dimethyl ether to data obtained with Diethylene glycol dimethyl ether is scientifically justified.

One group of 6 male and 6 female Wistar rats were exposed to a saturated Diethylene glycol dimethyl ether atmosphere at a concentrations of 11.1 mg/L for 7 hours. All animals survived without irreversible clinical signs or macroscopic findings. Body weight was not effects.