Registration Dossier

Toxicological information

Epidemiological data

Currently viewing:

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:
2008
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:
2005
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:
2005
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:
2005
Bibliographic source:
Science 2005; 310(5747): 422-422

Materials and methods

Study type:
other:
Endpoint addressed:
developmental toxicity / teratogenicity

Test material

Reference
Name:
Unnamed
Type:
Constituent

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).