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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 474
Deviations:
no
Principles of method if other than guideline:
Test procedure:
C3RO was given at doses of 5, 25, and 50 mg/kg to groups of
7 male Wistar Han rats, approximately 9 to 10 weeks old at
dosing; two groups of 7 control rats were given the vehicle
alone. Male rats only were used because there was no data to
indicate a sex difference in response to the toxicity of
C3RO. A group of 3 rats was given the positive control
cyclophosphamide, at 20 mg/kg.




Vehicle: 1% Carboxymethylcellulose / 0.1% Tween 80 in
purified water




Strain: Wistar Hanover, substrain AlpkHsdBrlHan:WIST




Positive control: Cyclophosphamide 2 mg/l in purified water
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% CMC (carboxymethyl cellulose)0.1 % Tween 80 in purified water
Analytical verification of doses or concentrations:
yes

Results and discussion

Details on results:
C3RO induced a statistically and biologically significant
increase in micronucleated immature erythrocytes (MIE) in
the bone marrow of male Wistar Han rats after a single oral
dose of 25 mg/kg, no increase in MIE was seen with 5 mg/kg.

There was no evidence of bone marrow toxicity as the

immature erythrocytes:mature erythrocytes (IE:E) ratio was
similar in the treated and vehicle control groups at both
sampling times.


It was concluded that, 25 mg/kg of C3RO induced a

statistically significant level of micronucleated immature
erythrocytes in the bone marrow of male Wistar Han rats.

Applicant's summary and conclusion

Conclusions:
It was concluded that, 25 mg/kg of C3RO induced a
statistically significant level of micronucleated immature
erythrocytes in the bone marrow of male Wistar Han rats.