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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

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:
Johnathan R. Furr, Christy S. Lambright, Vickie S. Wilson, Paul M. Foster and Leon E. Gray, Jr
Year:
2014
Bibliographic source:
TOXICOLOGICAL SCIENCES 140(2), 403–424 2014

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A short-term in vivo protocol, termed the Fetal Phthalate Screen (FPS), was applied to screen phthalates, phthalate alternatives and other chemicals for their ability to disrupt testis endocrine function in utero; an effect causally related to the development of male rat reproductive tract lesions and reproductive problems after birth in adulthood.
The FPS protocol was used to determine the relative potency of the phthalate esters that reduce fetal testis testosterone production
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-propylheptyl) phthalate
EC Number:
258-469-4
EC Name:
Bis(2-propylheptyl) phthalate
Cas Number:
53306-54-0
Molecular formula:
C28H46O4
IUPAC Name:
bis(2-propylheptyl) phthalate
Specific details on test material used for the study:
No further information given

Test animals

Species:
rat
Strain:
other: Harlan SD rats (Harlan Laboratories, Inc., Indianapolis, IN)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Details on exposure:
Pregnant rats were dosed from gestational day (GD) 14 to 18 at one dose level with one of 27 chemicals including phthalate esters, phthalate ester alternatives, pesticides known to inhibit steroidogenesis, an estrogen and a potent PPARalpha agonist and ex vivo testis testosterone production was measured on GD 18.
Duration of treatment / exposure:
GD 14 to GD 18
Doses / concentrations
Dose / conc.:
750 mg/kg bw/day
No. of animals per sex per dose:
3-4
Control animals:
yes, concurrent no treatment

Results and discussion

Observed effects

In utero, maternal treatment with phthalates and other chemicals during sexual differentiation produced the expected reductions in fetal testes testosterone produnction: DBP, DiBP, BBP, DPeP, DEHP, DHP, Di-HeP, DCHP, DINP, and DHeP, were positive and DEP, DMP, DPP, DoTP, DPHP, DIDP, and DINCH were negative.

Applicant's summary and conclusion

Conclusions:
DPHP did not lead to a decreased fetal testis testosterone production.