Potassium superoxide

Toxicity to reproduction

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

Test material information

Constituent 1

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 / concentrations

Doses / concentrations 1

Dose / conc.:

0 other: %

Remarks:

in drinking water

Doses / concentrations 2

Dose / conc.:

0.33 other: %

Remarks:

in drinking water

Doses / concentrations 3

Dose / conc.:

1 other: %

Remarks:

in drinking water

Doses / concentrations 4

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).