Bis(2-ethylhexyl) tetrabromophthalate

Endocrine disrupter mammalian screening – in vivo (level 3)

Administrative data

Endpoint:

endocrine disrupter mammalian screening – in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: explorative study

Data source

Reference

Reference Type:

publication

Title:

A Short-term In Vivo Screen Using Fetal Testosterone Production, a Key Event in the Phthalate Adverse Outcome Pathway, to Predict Disruption of Sexual Differentiation

Author:

Furr RJ et al

Year:

2014

Bibliographic source:

Toxicological Sciences 140, (2014) 403-424

Materials and methods

Principles of method if other than guideline:

short term in vivo screening assay termed Fetal Phthalate Screen; no Guideline followed

Test type:

Fetal Phthalate Screen

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) tetrabromophthalate

EC Number:

247-426-5

EC Name:

Bis(2-ethylhexyl) tetrabromophthalate

Cas Number:

26040-51-7

Molecular formula:

C24H34Br4O4

IUPAC Name:

1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate

Administration / exposure

Control animals:

yes

Details on study design:

3 pregnant rats per group were dosed by gavage from gestational day (GD) 14 to 18 at one dose level (750 mg/kg bw per day) with one of 27 chemicals, e.g. several phthalate esters and other chemicals suspected of being endocrine modulators. TBPH was included as chemical with ‘unknown activity’. The period of GD 14-18 is described as the ‘critical period for sexual differentiation’. On GD 18 testis testosterone production was measured ex vivo from 3 males per litter from three litters per chemical.

Results and discussion

Endocrine disrupting potential:

negative

Results of examinations

Clinical signs:

not specified

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Any other information on results incl. tables

TBPH showed no effects on fetal testosterone production, survival and maternal weight gain and was thus considered as negative in this screening assay.

Applicant's summary and conclusion

Executive summary:

In a short term in vivo screening assay of Furr et al. (2014) termed Fetal Phthalate Screen (FPS) 3 pregnant rats per group were dosed by gavage from gestational day (GD) 14 to 18 at one dose level (750 mg/kg bw per day) with one of 27 chemicals, e.g. several phthalate esters and other chemicals suspected of being endocrine modulators. TBPH was included as chemical with ‘unknown activity’. The period of GD 14-18 is described as the ‘critical period for sexual differentiation’. On GD 18 testis testosterone production was measured ex vivo from 3 males per litter from three litters per chemical. TBPH showed no effects on fetal testosterone production, survival and maternal weight gain and was thus considered as negative in this screening assay.