3-phenyl-L-alanine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Deviations from minimum requirements: 1) Four animals used; 2) Only one dose-level employed (2000 mg/kg bw); 3) Two slides analysed (50 nuclei/slide); 4) Manual scoring: DNA migration was evaluated as the difference between length of the tail and diameter of the nucleus. 5) Isolated nuclei instead of whole cells were employed; 6) Cell viability not reported; 7) the study does not include positive control.

Data source

Reference

Reference Type:

publication

Title:

The comet assay with 8 mouse organs: results with 39 currently used food additives.

Author:

Sasaki YF, Kawaguchi S, Kamaya A, Ohshita M, Kabasawa K, Iwama K, Taniguchi K and Tsuda S

Year:

2002

Bibliographic source:

Mutation Research, 519, 103-119.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

GLP compliance:

not specified

Type of assay:

mammalian comet assay

Test material

Test material information

Constituent 1

Reference substance name:

Aspartame

EC Number:

245-261-3

EC Name:

Aspartame

Cas Number:

22839-47-0

IUPAC Name:

methyl L-alpha-aspartylphenylalaninate

Test material form:

solid: crystalline

Details on test material:

purity: 99.5%

Test animals

Species:

mouse

Strain:

other: ddY mice - The strain name ddY stands for Deutschland, Denken, and Yoken. In Japan, ddY is used as a general purpose mouse.

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Frequency of treatment:

once

Post exposure period:

3 and 24 h after treatment

Doses / concentrations

Dose / conc.:

2 000 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

4

Positive control(s):

none

Examinations

Tissues and cell types examined:

stomach, colon, liver, kidney, bladder, lung, brain, bone marrow

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Positive controls validity:

not examined

Applicant's summary and conclusion

Conclusions:

In the present comet assay aspartame is negative in increases in DNA migration in all organs assayed.
Based on these results, it is considered that aspartame was not genotoxic in the organs assayed.