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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication

Data source

Reference
Reference Type:
publication
Title:
german [Zur Toxikologie des Äthylenglykol-Monoäthyläthers]; english translation [On the Toxicology of Ethyleneglycol-monoethylether]
Author:
Stenger EG, Aeppli L, Müller D, Peheim E, Thomann P
Year:
1971
Bibliographic source:
Arzneimittel-Forschung (Drug Research) 6: 880-885

Materials and methods

Principles of method if other than guideline:
Method: other: Subacute toxicity (subcutaneous and intravenous)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethoxyethanol
EC Number:
203-804-1
EC Name:
2-ethoxyethanol
Cas Number:
110-80-5
Molecular formula:
C4H10O2
IUPAC Name:
2-ethoxyethan-1-ol
Details on test material:
Name of the test substance as stated in the publication: "Äthylenglykol-Monoäthyläther";
purity: "zur Synthese";
purchased from Merck

Test animals

Species:
other: rat and dog
Strain:
other: Wistar "CF-Mehrzweck", Beagle
Sex:
male/female

Administration / exposure

Route of administration:
other: subcutaneous (rats), intravenous (dogs)
Duration of treatment / exposure:
4 weeks rats;
22 days dogs
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
subcutaneous rats: 5 mL/kg in back (100, 200, 400, 800 µL/kg/day)
intravenous dogs: 0.1, 0.5 mL/kg in extremities
No. of animals per sex per dose:
Rats: 5
Dogs: 2
Control animals:
other: yes, adminstration of same volume of physiological NaCl-solution at the corresponding application route

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Results for rats (4 weeks, sc.):

At doses of 100 and 200 µL/kg/day the injection sites showed slight chronic inflammation, but these were also observed in the corresponding control group (subcutaneous injection of physiological saline). At 400 µL/kg additionally to the slight chronic inflammation at the injection sites the 5 male rats showed testicular damage. In all animals of this dosage group changes in the liver and kidneys was observed. The observartions in the 800 µL/kg/day dose-group were the same as in the lower dose group, but more severe.

Results for dogs (22 days, iv.):

In no dose group histological changes of the inner organs were observed. At 100 µL/kg/day slight inflammation was observed at the injection sites, in two cases there was thrombosis of a vein. At 500 µL/kg/day all animals showed a predominant thrombophlebitis with severe inflammation.

Applicant's summary and conclusion