Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data, information on methods and results is sufficient to make an assessment.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Gadolinium periconceptional exposure: pregnancy and neonatal outcome
Author:
De Santis, M.
Year:
2007
Bibliographic source:
Acta Obstet Gynecol Scand. 2007; 86(1):99-101. [Acta obstetricia et gynecologica Scandinavica]

Materials and methods

Type of study / information:
This is a prospective cohort study of patients exposed to gadolinium in the first trimester of pregnancy to observe associated adverse events.
Endpoint addressed:
toxicity to reproduction / fertility
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
gadolinium derivatives (salts) - gadopentetate dimeglumine, gadobene acid, gadodiamide, and gadoteridol

Method

Ethical approval:
confirmed, but no further information available
Details on study design:
no data
Exposure assessment:
not specified
Details on exposure:
26 women exposed to gadopentetate dimeglumine in the periconceptional and first trimester period who had undergone an MRI owing to other clinical indications. All pregnancies were singleton and one patient had had three MRIs with intravenous contrast agent infusion in the same pregnancy because of astrocytoma in pregnancy.
Seventeen patients were exposed to MRI of the central nervous system (CNS), five to MRI of the spine, two to MRI of the pelvis, one to MRI of the abdomen, and one to MRI of the thorax. Six patients were also exposed to x-rays, five to the thorax and one to computerized tomography (CT) of the totalbody.

Results and discussion

Results:
In this prospective cohort study there were no maternal or neonatal complications and only one congenital anomaly at birth.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:
Under the conditions of this prospective cohort study there were no maternal or neonatal complications and only one congenital anomaly at birth, however, this study represents the only prospective investigation of gadolinium derivatives in pregnancy, but more data are necessary to exclude a teratogenic risk.