Registration Dossier
Registration Dossier
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EC number: 204-211-0 | CAS number: 117-81-7
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- other: Review
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from review
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Scientific opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk
- Author:
- SCENIHR (Scientific Committee on Emerging and Newly-Identified Health Risks),
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- publication
- Title:
- Decrease in anogenital distance among male infants with prenatal phthalate exposure.
- Author:
- Swan SH, Main KM, Liu F, et al.
- Year:
- 2 005
- Bibliographic source:
- Environ Health Perspect 2005; 113:1056-61.
- Reference Type:
- publication
- Title:
- Phthalate exposure during pregnancy and lower anogenital index in boys: wider implications for the general population.
- Author:
- Sharpe RM
- Year:
- 2 005
- Bibliographic source:
- Environmental Health Perspectives 2005; 113(8): 504-A505.
- Reference Type:
- publication
- Title:
- Toxicology - Panel finds no proof that phthalates harm infant reproductive systems.
- Author:
- Kaiser J.
- Year:
- 2 005
- Bibliographic source:
- Science 2005; 310(5747): 422-422
Materials and methods
- Study type:
- other:
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test material
- Reference substance name:
- Bis(2-ethylhexyl) phthalate
- EC Number:
- 204-211-0
- EC Name:
- Bis(2-ethylhexyl) phthalate
- Cas Number:
- 117-81-7
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,2-bis(2-ethylhexyl) benzene-1,2-dicarboxylate
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
Decreased anogenital distance
Swan et al. (2005) provided the first indications for the effects of phthalates on anogenital distance in a study of 134 male infants. Eighty five of the participating pregnant women gave a prenatal urine sample, which was analysed for nine phthalate metabolites commonly used as biomarkers of exposure to phthalates. Anogenital distance was measured after the delivery. For the 9 urinary metabolites measured, including monomethyl phthalate, monoethyl phthalate, mono-n-butyl phthalate, mono-iso-butyl phthalate, monobenzyl phthalate, mono-3-carboxypropyl phthalate, mono-2-ethyl-5-hydroxyhexyl phthalate, mono-2-ethylhexyl phthalate, mono-2-ethyl-5-oxohexyl phthalate. Four of these were associated with anogenital index (AGI=anogenital distance/kg bw), being monoethyl phthalate, mono-n-butyl phthalate, monobenzyl phthalate and mono-iso-butyl phthalate.
Boys with a reduced anogenital index (AGI) may have an increased likelihood of impaired testicular descent, penile volume and scrotal size, although in the study itself, no diseases or malformations were identified. However, the data were considered insufficient as solid evidence for an effect and need further elaborations with larger studies, but do add to the concern for male reproductive effects (Kaiser 2005, Sharpe 2005).
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