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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The Testicular DNA-Synthesis Inhibition Test (DSI-Test)
Author:
Seiler J.
Year:
1981
Bibliographic source:
In: Stech M. und San R.: Short-Term Tests Chem.Carcinog., Heidelberg

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- male mice were used
- on the eve of test day: animals received injection of 18,5 kBq (0,5 µCi) (methyl-14C)-thymidine (subcuaneously in the back)
- the next day: prelabeled animals are randomly assigned to test and control groups (receive test substance i.p.)
- 3 hours later: again injection with labeled thymidine subcutaneously (10 µL = 0,37 MBq (10µCi) (methyl-14C)-thymidine
- 45 min later: i.p. injection of 3,0 mg unlabeled thymidine in 0,2 ml physiological saline (provides for a 5x10^4-fold dilution of the radioactive thymidine)
- 30 min later: mice were sacrified and their testes excised
- testes were transferred into 5% trichloroacetic acid (TCA), homogenized and centrifuged
- the pellet was washed twice in 5% TCA, resuspended in fresh 5% TCA, heated for 30 min at 95°C for DNA hydrolysis, cooled and centrifuged
- DNA content was determined photometrically
- radioactivity was determined by liquid scintillation counting
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Details on test material:
- Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
3 hours
Frequency of treatment:
single application
Doses / concentrationsopen allclose all
Dose / conc.:
5 mg/kg bw/day
Dose / conc.:
15 mg/kg bw/day
Dose / conc.:
50 mg/kg bw/day
No. of animals per sex per dose:
no data
Control animals:
yes

Examinations

Statistics:
nonparametric test (Wilcoxon-rank-test or equivalent)

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Table 1: DSI Test Results of Ethylamine

Compound

Dose (mg/kg)

%DSI

Ethylamine

5 i.p.

0

15

0

50

5,6

Applicant's summary and conclusion

Conclusions:
Based on the DSI Test results of this publication, the test substance is a Noncarcinogen in mice.
Executive summary:

Male mice were treated with the test substance intraperitoneal. Three dose levels (5, 15, 50 mg/kb bw) were investigated. The results show that the test substance is a Noncarcinogen under the test conditions chosen.