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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
The spermicidal activity of hydrogen peroxide in vitro and in vivo
Author:
Wales RG
Year:
1959
Bibliographic source:
J Endocrin. 18: 236-244

Materials and methods

Principles of method if other than guideline:
Male reproductive toxicity study
GLP compliance:
no
Limit test:
yes

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
Test material form:
liquid
Remarks:
colourless
Specific details on test material used for the study:
Purity: 30%

Test animals

Species:
mouse
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: drinking water
Duration of treatment / exposure:
Exposure period: 7, 21 or 28 days
Premating exposure period (males): 7, 21 or 28 days
Frequency of treatment:
Daily
Details on study schedule:
Exposure period: 7, 21 or 28 days
Premating exposure period (males): 7, 21 or 28 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: %
Remarks:
in drinking water
Dose / conc.:
0.33 other: %
Remarks:
in drinking water
Dose / conc.:
1 other: %
Remarks:
in drinking water
Dose / conc.:
3 other: %
Remarks:
in drinking water
No. of animals per sex per dose:
12 males per dose
Control animals:
no

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
LOAEL
Effect level:
0.33 other: %
Based on:
test mat. (dissolved fraction)
Sex:
male
Basis for effect level:
other: no treatment-related adverse effects except body weight gain

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
3 other: %
Based on:
test mat. (dissolved fraction)
Sex:
male/female
Basis for effect level:
other: no treatment-related adverse effect

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the substance had no significant effects on the reproductive capacity of male mice.
Executive summary:

A study was conducted to determine the potential reprotoxicity of the substance. Male mice were administered the substance in drinking water at 0, 0.33, 1 and 3% for 7, 21 or 28 days before the mating period and then mated with normal females. The test substance treatment continued through the mating period. All female mice mated to treated males became pregnant within a few days and in each case healthy pups were born in litters of normal size. Pregnant mice that continued to consume 1% test substance in water until near term showed some delays in parturition compared to dams consuming untreated tap water, although the effect was small and inconsistent. The concentration, morphology and motility of the mouse spermatozoa after 3 weeks of treatment appeared normal. Under the study conditions, the substance had no significant effects on the reproductive capacity of male mice (Wales, 1959).

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