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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, reasonably documented, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Iron status and iron balance during pregnancy.A critical reappraisal of iron supplementation.
Author:
Milman N, Bergholt T, Byg K-E
Year:
1999
Bibliographic source:
Acta. Obstet. Gynecol. Scand. 78: 749-757.

Materials and methods

Type of study / information:
Type of experience: other: Iron supplementation in human pregnancy - analysis of placebo-controlled studies
Endpoint addressed:
other: effects of iron supplementation during pregnancy
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Analysis of placebo-controlled studies of the effects of iron supplementation on iron blood levels and pregnancy outcome.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Iron sulphate
EC Number:
231-753-5
EC Name:
Iron sulphate
Cas Number:
7720-78-7
IUPAC Name:
iron(2+) sulfate
Test material form:
not specified
Details on test material:
The iron formulations ingested by the individuals in the study were described as ferrous iron.

Method

Ethical approval:
not applicable
Remarks:
review of published studies
Exposure assessment:
measured

Results and discussion

Results:
Iron treated women had greater iron reserves, higher haemoglobin and lower incidence of iron-deficiency anaemia than placebo treated women, both in pregnancy and postpartum. Children born to iron-treated women had higher serum ferritin levels than those born to placebo-treated women. Birth weight is decreased at low haemoglobin levels of 86 g/l and at high levels of > 145 g/l

Applicant's summary and conclusion

Conclusions:
This investigation based on literature studies placebo controlled studies of supplementation concluded that supplementation with 65 mg/day from 20 weeks of gestation is sufficient to prevent iron deficiency anaemia. One study concluded that birth weight is decreased at low haemoglobin levels of <86 g/l and at high levels of > 145 g/l. However, in eight placebo-controlled studies, no harmful effects of supplementation during pregnancy on birth weight of infants or frequency of perinatal complications were discovered.
Executive summary:

A literature review of placebo-controlled studies published between 1975 and 1997 was carried out. The serum ferritin concentrations of placebo  

treated women were compared with those of iron-treated women, during and after pregnancy.
The effect of supplementation on peri-natal complications and birth weight wasconsidered.

Iron treated women had greater iron reserves, higher haemoglobin and lower incidence of iron-deficiency anaemia than placebo treated women, both 

in pregnancy and postpartum. Children born to iron-treated women had higher serum ferritin levels than those born to placebo-treated women. Birth 

weight is decreased at low haemoglobin levels of <86 g/l and at high levels of > 145 g/l.

This investigation based on literature studies placebo controlled studies of supplementation concluded that supplementation with 65 mg/day from 20 weeks of gestation is sufficient to prevent iron deficiency anaemia. One study concluded that birth weight is decreased at low haemoglobin levels of

<86 g/l and at high levels of > 145 g/l. However, in eight placebo-controlled studies, no harmful effects of supplementation during pregnancy on birth weight of infants or frequency of perinatal complications were discovered.