Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Effects of malonic, maleic, citric and caffeic acids on the motiliy of human sperm and penetration of cervical mucus
Author:
Brown-Woodman PD
Year:
1985
Bibliographic source:
Int. J. Fertil. 30, 38-44
Reference Type:
secondary source
Title:
Final report on the Safety Assessment of Maleic Acid
Author:
American College of Toxicology
Year:
2007
Bibliographic source:
International Journal of Toxicology 26, 125-130

Materials and methods

Principles of method if other than guideline:
The spermicidal effect of maleic acid was evaluated by adding the acid to the sperm, and by observing sperm survival and penetration following addition to human cervical mucus.
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Observed effects

A concentration of 0.1 % maleic acid reduced the pH from 7.5 to 5.5 and rendered human spermatozoa immotile within 30 min, and 1 % (pH 1.5) was almost instantaneously spermicidal. In capillaries filled with cervical mucus, the incorporation of 0.01 % maleic acid was sufficient to reduce sperm penetration, and at 0.1 % penetration was completely prevented.

Applicant's summary and conclusion

Conclusions:
Maleic acid was spermicidal and reduced sperm penetration at concentrations of 0.01 % and below.
Executive summary:

The spermicidal effect of maleic acid was evaluated by adding the acid to the sperm, and by observing sperm survival and penetration following addition to human cervical mucus.

A concentration of 0.1 % maleic acid reduced the pH from 7.5 to 5.5 and rendered human spermatozoa immotile within 30 min, and 1 % (pH 1.5) was almost instantaneously spermicidal. In capillaries filled with cervical mucus, the incorporation of 0.01 % maleic acid was sufficient to reduce sperm penetration, and at 0.1 % penetration was completely prevented.