Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report/publication which meets basic scientific principles. Comparable to guideline study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003

Materials and methods

Principles of method if other than guideline:
See details in remarks on material and methods.
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylamine

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
6 hours per day, 5 days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 8, 16, 32, 62, 125 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, sham-exposed

Examinations

Tissues and cell types examined:
Peripheral blood

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Frequency of Micronuclei in Mouse Peripheral Blood Erythrocytes Following Treatment with Diethylamine by Inhalation for 13 Weeks:

 Dose (ppm)

Micronucleated Normochromatic Erythrocytes/1000 cells    

                         
 Male  Female                            
0  2.80 ± 0.30  2.60 ± 0.29                            
8  4.60 ± 0.60  2.50 ± 0.61                            
16  4.10 ± 0.48  2.20 ± 0.25                            
32  3.30 ± 0.34  3.50 ± 0.57                            
62  4.00 ± 0.52  3.80 ± 0.60                            
125  2.60 ± 0.33  2.20 ± 0.25                            

No significant increase in micronucleated NCEs was observed in males or females and all tested dose groups.

Applicant's summary and conclusion