Registration Dossier
Registration Dossier
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EC number: 258-469-4 | CAS number: 53306-54-0
Toxicity to reproduction: other studies
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:
- 2 014
- 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
- 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:
- 1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
Constituent 1
- 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
Applicant's summary and conclusion
- Conclusions:
- DPHP did not lead to a decreased fetal testis testosterone production.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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