Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system, non-guideline study, results refer to external concentration only.

Data source

Reference
Reference Type:
publication
Title:
Embryotoxic effects of eight organic peroxides and hydrogen peroxide on three-day chicken embryos
Author:
Korhonen A, Hemminki K, Vainio H
Year:
1984
Bibliographic source:
Environmental research 33, 54-61

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
3-day old embryos were exposed by applying the substance on the inner shell membrane in the air chamber.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dicumylperoxide (DICUP)
- Analytical purity: 96-99%
Supplier: Merck, Schuchardt, München

Test animals

Species:
other: white leghorn chicken eggs

Administration / exposure

Route of administration:
other: inner shell membrane of air chamber
Vehicle:
acetone
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
14d
Doses / concentrations
Remarks:
Doses / Concentrations:
0.38, 0.75, 1.5 and 3.0
Basis:
other: µmole/egg
No. of animals per sex per dose:
30
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOAEC
Effect level:
0.38 other: µmole/egg
Sex:
not specified
Basis for effect level:
other: mortality, malformations

Any other information on results incl. tables

Number of early deaths (after 2d) were only about 20% (7 and 6 from 30 eggs at 1.5 and 3.0 µmole/egg, respectively). At a concentration of 3.0 µmole/egg 16 late deaths showed malformation at day 14 (53% of initial). 8 and 7 late deaths showed malformation at 0.75 and 1.5 µmole/egg, respectively.

The authors discussed that the low rate of early deats may be related to the fact that the chemicla was not lethal at the doses tested or that high lethal concentrations did not reach the embryo during teh 2 days, but lower teratogenic doses did.

Applicant's summary and conclusion

Conclusions:
The authors stated that all of the tested peroxides (inicluding CAS 80-43-3) are rather untoxic to the embryos (all had ED50 >100 µmole/egg), compared to other chemicals tested with ED50 values from 18 -90 nmole/egg for thiurams and 2.5 -26 nmole/egg for dithiocarbamates.