Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
DNA damage induced in vivo in various tissues by nitrochlorobenzene derivatives
Author:
Cesarone, C.F.; Bolognesi, C.; Santi, L.
Year:
1983
Bibliographic source:
Mutation Research 116: 239-246 (1983)

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Type of assay:
other: detection of single strand breaks by alkaline elution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: Swiss CD 1
Sex:
male
Details on test animals and environmental conditions:
Weight: 25 - 30 g,
Husbandry: 5-6 per cage
Temperature: 21 +/- 0.5 C
Controlled light and humidity, commercial food and water ad libitum.
Food was removed 16 h before killing.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
DMSO
Duration of treatment / exposure:
4h
Frequency of treatment:
single
Post exposure period:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
0 - 30 - 60 - 90 - 180 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
12
Control animals:
yes, concurrent vehicle
Positive control(s):
Nitrosomethyl urea (NMU), nitrosodimethylamine (NDMA), same procedure

Examinations

Tissues and cell types examined:
Brain, Liver, Kidney
Details of tissue and slide preparation:
Tissues were minced and cooled to 1- 4 C immediately after killing. Cellular nuclei were isolated by centrifugation in saline at 400 rpm for 2 minutes.Aliquots of about 0.5 to 1 million nuclei were transfered to membrane filters and DNA was eluted under alkaline conditions (pH = 12,3, 1 h, 6 min per fraction). DNA content was determined by a fluorimetric procedure.

Results and discussion

Test results
Sex:
male
Genotoxicity:
positive
Remarks:
Single strand breaks were detected in all tissues
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
DNCB caused DNA single strand breaks in brains, levers, and kidney of male swiss CD1 mice.