Registration Dossier

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
reproductive toxicity, other
Remarks:
other: Mammalian germ cell cytogenetic assay
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
publication
Title:
Mutagenitatsprufung in Spermakopftest/Maus und mutagene Potenz van 2 Densinfektionsmitteln auf Basis von Peressigsaure bzw Phenolen
Author:
Koch S. et al
Year:
1989
Bibliographic source:
Zbl Hyg 188:391-403

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mammalian germ cell cytogenetic assay
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Peracetic acid
EC Number:
201-186-8
EC Name:
Peracetic acid
Cas Number:
79-21-0
Molecular formula:
C2H4O3
IUPAC Name:
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions

Test animals

Species:
mouse
Strain:
ICR
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
Exposure period: 5 days
Frequency of treatment:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
2.6 mg/kg bw/day
Remarks:
2.6 mg peracetic acid/kgbw/d (injection intraperitoneal)
Dose / conc.:
1.3 mg/kg bw/day
Remarks:
1.3 mg peracetic acid/kgbw/d (injection intraperitoneal)
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Remarks on result:
other: see Remarks
Remarks:
see "Any other information"

Results: F1 generation

Effect levels (F1)

Key result
Remarks on result:
other: see Remarks
Remarks:
see "Any other information"

Overall reproductive toxicity

Key result
Reproductive effects observed:
not specified

Any other information on results incl. tables

RESULTS


The results showed that a dose of 2.6 mg peracetic acid/kgbw doubled the incidence of sperm head abnormalities. When the dose was reduced to 1.3  mg/kgbw, no increase in anomalies was seen. Statistically significant  results were not found at two consecutive dose levels. There is no sufficient evidence from this study to conclude if treatment caused abnormal sperm heads.

Applicant's summary and conclusion

Executive summary:

The results showed that a dose of 2.6 mg peracetic acid/kgbw doubled the incidence of sperm head abnormalities. When the dose was reduced to 1.3  mg/kgbw, no increase in anomalies was seen. Statistically significant  results were not found at two consecutive dose levels. There is no sufficient evidence from this study to conclude if treatment caused abnormal sperm heads.

Categories Display