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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

Reference
Name:
Unnamed
Type:
Constituent
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