Registration Dossier

Ecotoxicological information

Endocrine disrupter testing in aquatic vertebrates – in vivo

Administrative data

Endpoint:
fish: other
Remarks:
fish estrogen receptor.
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1995

Data source

Reference
Reference Type:
publication
Title:
A Variety of Environmentally Persistent Chemicals, Including Some Phthalate Plasticizers, Are Weakly Estrogenic
Author:
Jobling, S. et. al.
Year:
1995
Bibliographic source:
Environmental Health Perspectives, Volume 103, Number 6, June 1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Direct binding of the chemical to the fish estrogen receptor
Deviations:
not applicable
Principles of method if other than guideline:
Because of their documented presence in the aquatic environment, the initial examination for estrogenicity was carried out by measuring direct binding of the chemicals to the fish estrogen receptor.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test organisms

Aquatic vertebrate type:
fish
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
The initial screening process was carried out using a cytosolic extract from the liver. Estradiol receptor-binding sites are present here in both male and female fish.

Study design

Total exposure duration:
1 h

Test conditions

Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
1 h
Dose descriptor:
NOEC
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: stimulation of endocrine receptor activity
Remarks:
liver

Any other information on results incl. tables

At this high concentration (22 mg/L) the stimulation of the endocrine receptor (ER) was, however, less than 15 % of the maximum response obtained with 17ß-estradiol. It is reported that BHT did not “impair binding of tritiated estradiol to the ER”. Thus, there was no proof for an interaction of BHT with the ER receptor.

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
No stimulation of the receptor activity was determined for BHT until concentrations exceeded a concentration of 1E-4 M (= 22 mg/L).
Executive summary:

Jobling et al. used a fish endocrine receptor (ER) binding assay with Oncorhynchus mykiss cells. The initial screening process was carried out using a cytosolic extract from the liver. No stimulation of the receptor activity was determined for BHT until concentrations exceeded a concentration of 1*10-4 M (22 mg/L). At this high concentration the stimulation of the ER was, however, less than 15 % of the maximum response obtained with 17ß-estradiol. Jobling et al. additionally reported that BHT did not “impair binding of tritiated estradiol to the ER”. Thus, there was no proof for an interaction of BHT with the ER receptor.