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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Reference Type:
publication
Title:
Effects of ethylene glycol and metabolites on in vitro development of rat embryos during organogenesis.
Author:
Klug, S., Merker, H.-J., Jäckh, R.
Year:
2001
Bibliographic source:
Toxicology in Vitro 15, 635 - 642

Materials and methods

Principles of method if other than guideline:
The objective of the study was to investigate possible adverse effects on the in vitro development of rat embryos during organogenesis.
GLP compliance:
not specified
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Up to 100 mM ethylene glycol (EG) in the culture medium, no adverse effects on the growth and differentiation of the cultured embryos in comparison to the controls could be observed. The 7% rate of embryos revealing dysmorphogenesis is within the range of historical controls. The significant reduction of the yolk sac diameter in this group is meaningless since neither the protein content nor the crown-rump-length of the cultured embryos are affected.

At a concentration of 200 mM EG in the culture medium, the values for the growth parameters protein content and crow-rump-length as well as for the differentiation variable score significantly lower. The rate of embryos showing dysmorphogenesis increased. to 47%. The affected embryos showing dysmorphogenesis of head region (7 embryos), unproportionally large heart (1 embryo), unproportionally large heart (1 embryo), incomplete flexion (5 embryos) and some of them unclearly-shaped somites. Based on these results, the NOEC for ethylene glycol in this system ist estimated to be 100 and 200 mM. It was also shown that glycolic acid is the metabolite most likely responsible for the developmental toxicity of EG.

Applicant's summary and conclusion