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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 4-chlorophenylisocyanate, purity: 99.6%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
single administration
Frequency of treatment:
single administration
Post exposure period:
animals were sacrificed 16, 24 and 48 hours after the administration of the test substance
Doses / concentrations
Remarks:
Doses / Concentrations:
50 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
10 mice
Positive control(s):
positive control: cyclophoshamide; dose: 20 mg/kg bw

Examinations

Tissues and cell types examined:
tissue examined: mouse bone marrow
cell types examined: polychromatic to normochromatic erythrocytes, number of polychromatic erythrocytes showing micronuclei

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
1 of 40 animals died before the end ot the test due to the acute ip toxicity
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

RS-Freetext:
no indications of a clastogenic effect of p-chlorophenylisocyanate; 

the positive control, cyclophosphamide, was functional.

Applicant's summary and conclusion

Executive summary:

method: micronucleus test on the mouse according OECD 474

result: negative - no indications of a clastogenic effect of the test substance were found after a single intraperitoneal treatment with 50 mg/kg bw