Registration Dossier

Diss Factsheets

Administrative data

health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference Type:
Comparison of Sperm Viability with Seminal Plasma Metal Levels
Dawson, E. B. et al.
Bibliographic source:
Biological Trace Element Research 64(1-3): 215-219

Materials and methods

Study type:
biological effect monitoring
Endpoint addressed:
toxicity to reproduction / fertility
Principles of method if other than guideline:
This study compares the semen levels of aluminum (Al) in relation to live sperm in semen samples from 64 apparently healthy men.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): Aluminium
- Analytical purity: no data


Type of population:
Ethical approval:
confirmed, but no further information available
Details on study design:
Semen samples were collected from 64 apparently healthy men (21-35 yr of age) who were recruited within the Department of Obstetrics and Gynecology at The University of Texas Medical Branch. Samples were examined for viability within 2 hours. All men were considered healthy with no apparent chronic or acute disease and were regularly employed in an environment that was free of hazardous or polluted materials. All resided in a suburban community. In compliance with the regulations of the institutional human research committee, the study protocol was explained to the subjects, and human consent forms were signed. Each subjects completed an extensive questionnaire of his medical history, tobacco and drug use, alcohol and caffeine consumption, environmental work exposures, dietary and nutrition supplementation, and reproductive history. Each received a urological examination and all were found to have no abnormality of their reproductive system.
The sperm viability was determined with an American Optical Binocular microscope and expressed as percent of total sperm count showing forward movement. All estimates were in triplicate of separate fields with a high-power lens.
The metal was measured by flameless atomic absorption spectrophotometry and the concentrations expressed as mg or µg/100 mL.
By dividing the population into three tertiles based on viability (<25%, 25-50%, and >50%), the group mean metal levels of the high and low tertiles were compared for statistical significance by ANOVA. The resultant data were also studied by Spearman´s rank correlation between the individual percent viability and the metal levels.

Results and discussion

The seminal plasma levels grouped by tertiles according to sperm viability are listed in Table 1. Comparison of the viability of the <25% tertile with the >50% tertile shows that the >50% level of viability is associated with a significant decrease in the seminal plasma levels of aluminium (82%, p < 0.05). Spearman´s rank correlation between sperm viability and the semen plasma metal levels for the entire population showed an inverse correlation to aluminium (p<0.01). Linear regression between the live sperm counts and semen level of Al show that metal level was inversely correlated with the percentage of live sperm.

Any other information on results incl. tables

Table 1. Seminal plasma aluminium levels (mean ± SD) grouped by sperm viability (%) and compared between high and low tertiles.








Aluminium (µg/L)

101 ± 36

59 ± 18

18 ± 8*






* p ≤ 0.05


Table 2. Spearman’s rank correlation between sperm viability and seminal plasma aluminium level.









Applicant's summary and conclusion

The results of this study do not indicate adverse effects in sperm viability in relation to seminal plasma aluminiun levels.

Categories Display