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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Adequacy of study:
supporting study

Data source

Reference
Reference Type:
publication
Title:
Effects of food additive hydrogen peroxide studied in fetal development [Japanese, English translation]
Author:
Moriyama I, Hiraoka K, Fujita M, Ichijo M and Ioka H
Year:
1982
Bibliographic source:
Acta Obst Gynaec Japan 34, 2149-2154

Materials and methods

Principles of method if other than guideline:
Method: other: see below
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen peroxide
EC Number:
231-765-0
EC Name:
Hydrogen peroxide
Cas Number:
7722-84-1
Molecular formula:
H2O2
IUPAC Name:
hydrogen peroxide
Details on test material:
IUCLID4 Test substance: other TS: 10% hydrogen peroxide

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
"one week during the critical period"
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.02, 0.1, 2 or 10% in feed
Basis:

Control animals:
yes, concurrent no treatment
Details on study design:
Sex: female
Duration of test: 20 days (A), approximately 2 months (B)

Results and discussion

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
0.02 other: %
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
Hydrogen peroxide aqueous solutions were mixed with powdered
feed to 10, 2, 0.1 or 0.02% and administered to groups of 5
- 8 (A) or 2-3 (B) pregnant rats for one week during the
critical period of pregnancy. The foetuses were (A) removed
on day 20 for investigations or (B) were allowed to go
through normal delivery and the offspring were followed-up
for about four weeks.

(A) At the high dose level the dam body weight did not
increase markedly. Foetal resorptions were increased and the
foetal body weight was decreased; most of the foetuses were
close to death. No external malformations were found in any
of the dose groups. Haemorrhaging of internal organs (eye,
parietal region of the brain, cardiopulmonary region, torso)
was dose dependently increased in the dose range 0.1 - 10%
H2O2. Skeletal hypoplasias occurred dose dependently at the
two highest levels.

(B) All the neonates of the 10% treatment group died
within 1 week post partum., the body weights were low and
the number of live births was decreased. In the other dose
groups there was no major effect on the development of
neonates.

Applicant's summary and conclusion