Registration Dossier
Registration Dossier
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EC number: 454-140-6 | CAS number: 376608-71-8
Specific investigations: other studies
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:
- 2 006
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- -
- EC Number:
- 454-140-6
- EC Name:
- -
- Cas Number:
- 376608-71-8
- Molecular formula:
- C9H9F2N*C8H8O3
- IUPAC Name:
- (1R)-2-(3,4-difluorophenyl)cyclopropan-1-aminium (2R)-2-hydroxy-2-phenylacetate
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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