Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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: see 'Remark'
Remarks:
The target chemical belongs to the homologues series of glymes, where there is an incremental increase in the number of CH2CH2O units. Therefore, it can be assumed that target and other glyme members (mono-, di-, and triglyme) share the same toxic mode action.

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:
- Analytical purity: not stated
- physical state: clear colourless liquid
- MW 134.18
- LogPow - 0.36
- Vapour pressure (20°C) 60 Pa
- Water solubility miscible

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:
other: No effects
Body weight:
No effects
Gross pathology:
No effects
Other findings:
None

Any other information on results incl. tables

Analogue approach justification:

The analogue approach using glymes as source chemical is justified:

a.   The target chemical belongs to the homologues series of glymes, where there is an incremental increase in the number of CH2CH2O units. Therefore, it can be assumed that target and other glyme members (mono-, di-, and triglyme) share the same toxic mode action.

b.   The findings in repeated dose toxicity studies are comparable for target and source chemicals: the target is the male reproductive organ. Further, findings in thymus and altered hematological values are indicative of altered blood system.

c.    The findings in reproductive performance are comparable: No live pubs and/or reduced number of pubs were the common finding.

d.   The findings in developmental toxicity studies are comparable: the most notable findings were paw skeletal malformations. These findings were observed also at dose levels not associated with apparent maternal toxicity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LC0: 11 mg/L for 7 h Criteria used for interpretation of results: expert judgment
Conclusions:
No classification is warranted for tetraglyme based on the read-across approach using diglyme as read-across supporting substance. Diglyme did not induce any effect in rats exposed to the saturated concentration of 11 mg/L for 7h.
Executive summary:

The acute inhalation toxicity of tetraglyme was assessed based on the read-across approach using diglyme as read-across supporting substance.

One group of 6 male and 6 female Wistar rats were exposed to a saturated diglyme atmosphere at a concentrations of 11.1 mg/L for 7 hours. All animals survived without irreversible clinical signs or macroscopic findings.

Due to the higher molecular mass and lesser volutility the acute inhalation toxicity of tetraglyme is likely to be less potent than diglyme.

No classification is warranted for tetraglyme.