L-Tyrosine, N-(aminocarbonyl)-3-methoxy-O,.alpha.-dimethyl-

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1990-1991

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Non-GLP. 20 cells were examined instead of 100 cells/animals recommendation. 2 doses were checked instead of 3 doses. Dose selection was not met guideline requirement.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

yes

Principles of method if other than guideline:

20 cells were examined instead of 100 cells/animals recommendation.
2 doses were checked instead of 3 doses.
Dose selection was not met guideline requirement.

GLP compliance:

no

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-

EC Number:

608-271-2

Cas Number:

28861-00-9

Molecular formula:

C13H18N2O5

IUPAC Name:

Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-

Test animals

Species:

mouse

Strain:

other: CLFP

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 30 g (average weight)
- Assigned to test groups randomly: [no/yes, under following basis: ] 2 test groups and 1 vehicle control, 1 positive control group, 1 unchanged control group
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: oleum helianthi (sunflower oil)
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

24 h, 48 h

Frequency of treatment:

1 treatment/test group

Post exposure period:

24 h/50 % of the test animals
48 h/50 % of the test animals

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
250 mg/bwkg
Basis:
other: 1/20 x LD50

Doses / concentrations 2

Remarks:

Doses / Concentrations:
125 mg/bwkg
Basis:
other: 1/40 x LD50

No. of animals per sex per dose:

1st test group, 250 mg/bwkg, 20 animals
2nd test group, 125 mg/bwkg, 20 animals
vehicle control group, 0.1 mL oleum helianthi/animal, 20 animals
Positive control group, 100 mg/kg Cyclophosphamide, 10 animals
Unchanged control, 10 animals

Control animals:

yes, concurrent no treatment

yes, concurrent vehicle

Positive control(s):

cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: oral, gavage
- Doses / concentrations: 100 mg/bwkg

Examinations

Tissues and cell types examined:

mouse bone marrow, from femur

Details of tissue and slide preparation:

DATTA and co-workers (1970), Wurster (1972).

Statistics:

Fisher-probe, Delanuois (1979).

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Experimental results has not shown genotoxic effects in the examined doses of the test substance.