Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Remarks:
(limited details on study design and results provided)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: A 14-day repeat dose toxicity study with 2-chlorophenol was performed including evaluation of sister chromatid exchanges. Groups of 12 male and female CD-1 mice were exposed to 2-chlorophenol at dose levels of 35, 69 and 175 mg/kg bw/day by oral gavage once daily for 14 consecutive days. Vehicle control animals received the vehicle, corn oil, only. In addition a treatment naive and a positive control group (cyclosphosphamide, 25 mg/kg bw) were included.

- Parameters analysed / observed: SCE (testes and bone marrow).
GLP compliance:
not specified
Type of assay:
sister chromatid exchange assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Assigned to test groups randomly: yes
- Housing: individually in plastic shoebox cage with hardwood sawdust bedding

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° +/- 2°C
- Humidity (%): relative humidity 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
- Amount of vehicle: 10 mL/kg bw
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: prepared on day of administration

Duration of treatment / exposure:
14 days
Frequency of treatment:
Once daily
Post exposure period:
none
Doses / concentrationsopen allclose all
Dose / conc.:
35 mg/kg bw/day
Remarks:
Doses tested were 35, 69 and 175 mg/kg bw/day. All animals at 175 mg/kg bw/day died and could not be evaluated. Highest evaluated dose was 69 mg/kg bw/day.
Dose / conc.:
69 mg/kg bw/day
Remarks:
Doses tested were 35, 69 and 175 mg/kg bw/day. All animals at 175 mg/kg bw/day died and could not be evaluated. Highest evaluated dose was 69 mg/kg bw/day.
No. of animals per sex per dose:
12
Control animals:
yes, concurrent no treatment
yes, concurrent vehicle
other: yes, positive control
Positive control(s):
cyclophosphamide
- Route of administration: oral gavage
- Doses / concentrations: 25 mg/kg bw

Examinations

Tissues and cell types examined:
testes and bone marrow

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Additional information on results:
Mortality was observed in the highest dose group. In the mid-dose group, a decrease in body weight was observed. Administration of the low and mid-dose caused hyperactivity in the test animals. No alterations on clinical or haematological parameters were observed. Females revealed reduced liver, brain and spleen weights. No gross anomalies were observed. No biologically or statistically significant compound-related effects on DNA repair were observed in the examined tissues.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative