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additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed publication utilizing non-standard methods to measure estrogenic activity.

Data source

Reference Type:
Characterisation and implementation of the ERE-CALUX bioassay on indoor dust samples of kindergartens to assess estrogenic potencies
Vandermarken T, De Galan S, Croes K, Van Langenhove K, Vercammen J, Sanctorum H, Denison MS, Goeyens L, Elskens M, Baeyens W
Bibliographic source:
J. Steroid Biochem. Mol. Biol.

Materials and methods

Principles of method if other than guideline:
Estrogen responsive elements chemically activated Luciferase gene eXpression bioassay in human ovarian carcinoma cell line, BG1, stably transfected with a ER responsive luciferase reporter gene.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
Automatically generated during migration to IUCLID 6, no data available
Test material form:
other: dust collected from floor surfaces

Results and discussion

Any other information on results incl. tables

The bio-analytical equivalent concentrations of the extracts were calculated based on the positive control (estradiol) dose response curve for ERE-CALUX assay relative light units using the following equation:

BEQ= EC50(E2 standard)/EC50(sample)

The activities of the dust samples were reported to range from 436 pg/E2 equivalents/g dust to 8710 pg E2 equivalents/g dust. A semi-quantitative interior scoring system was used to document some of the environmental factors present in the classrooms including floor type, furniture material, toy material and the presence of computers. There was a positive correlation between the estrogenic activity expressed in pg E2 equivalents/g dust and interior score values with a rho-value of 0.82, p<0.0001.

Applicant's summary and conclusion

The authors concluded that there was a significant relationship between phthalate concentration and estrogenic activity but this relationship significantly improved when DINP and DIDP were subtracted from the total phthalates. Therefore, DINP and DIDP do not contribute to the CALUX response supporting the evidence that DINP and DIDP do not display estrogenic properties.