Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented report equivalent or similar to OECD guidelines
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Reference substance name:
FDA 71-55
FDA 71-55
Details on test material:
- Name of test material (as cited in study report): tartaric acid
- Physical state: fine granular
- Lot/batch No.: 71382

Test animals

Crj: CD(SD)
Details on test animals or test system and environmental conditions:
- Source:
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 280-350 g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: 1 to 5 per cage, sanitary cages and bedding were used, and changed two times per week, at which time water containers were cleaned, sanitized and filled. Once a week, cages were repositioned on racks; racks were repositioned within rooms monthly.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days

Administration / exposure

Route of administration:
oral: gavage
- Vehicle(s)/solvent(s) used: physiol. saline
Duration of treatment / exposure:
acute: one application
subacute: 5 days
Frequency of treatment:
acute: one application
subacute: 5 dose 24 hour apart
Post exposure period:
acute: 6 h, 24 h, 48 h
subacute: 6 h
Doses / concentrationsopen allclose all
Doses / Concentrations:
1.25 mg/kg bw
actual ingested
in both acute and subacute tests
Doses / Concentrations:
12.5 mg/kg bw
actual ingested
in both acute and subacute tests
Doses / Concentrations:
125 mg/kg bw
actual ingested
in both acute and subacute tests
No. of animals per sex per dose:
5 male rats per dosage group and 3 male rats in negative control
Control animals:
yes, concurrent vehicle
Positive control(s):
triethylenemelamine (in acute test, no given in subacute test)
- Route of administration:intraperitoneally
- Doses / concentrations: 0.1 mg/ml


Tissues and cell types examined:
the chromosomes of each cell were counted and oly diploid cells were analyzed. they were scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cell with greater than ten abberrations, polyploidy, pulverization, and any other chromosomal aberrations which were observed.
Details of tissue and slide preparation:
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):four hours after the last compound administration, and two hours prior ro killing, each animal was given 4 mg/kg of colcemid intraperitoneally in order to arrest the bone marrow cells in C-mitosis. Animals were kill by using CO2, and the adhering muscle and epiphysis of one femur were removed. the marrow "plug" was removed with a tuberculin syringe and an 18 gauge needle, aspirated into 5 ml of Hanks' balanced salt solution in a test tube and capped. the specimens were centrifuged at 1500 RPM in a table-top centrifuge for 5 minutes, decanted, and 2 ml of hypotonic 0.5 % KCl solution was added with gentle agitation to resuspended the cells. the specimens were then placed in a 37 ℃ water bath for 20 minutes at 1500 RPM for 20 minutes in order to swell the cells. following centrifugation for 5 minutes at 1500 RPM, the supernatant was decanted and 2 ml of fixative (3:1absolute methanol:glacia aceitc acid) was added. the cells were resuspended in the fixative with gentle agitation, capped, and placed at 4℃ for 30 minutes. the specimens were again centrifuged , decanted, 2 ml of prepared fixative was added, and the cells were resuspended and placed at 4℃ overnight.

DETAILS OF SLIDE PREPARATION: the following day after sampling, the specimens were again centrifuged, decanted and 0.3-0.6 ml of freshly prepared fixative was added to obtain a suitable density. the cell were resuspended and 2-3 drops of the suspension were allowed to drop onto a clean, dry slide held at 15 ℃ from the horizontal. as the suspension flowed to the edge of the slide, it was ignited by an alcohol burner and allowed to flame. following ignition, the slides were allowed to dry at room temperature overnight. fuplicate slides were prepared. the slides were then mounted using permount and 24X50 mm coverglasses.

METHOD OF ANALYSIS: the preparation were examined using microsopes with brightfield optics and xenon light sources.

Results and discussion

Test results
not examined
Vehicle controls validity:
Negative controls validity:
not examined
Positive controls validity:
Additional information on results:
acute study:
the negative control group and all three dosage level groups of the test compound contained no aberrations. The positve control group exhibited the expected severe chromosomal damage due to the positive control compound. the mitotic indices were within normal limits.
subacute study:
the negative control group contained no aberrations. The low level dosage group of the test compound contained no aberrations. The mitotic indices were somewhat depressed in the intermediate and LD5 dosage level groups of the test compound.

Applicant's summary and conclusion

Interpretation of results (migrated information): negative
The compound produced no detectable significant aberration of the bone marrow chromosomes of rats when administered orally at the dosage levels employed in this study.
Executive summary:

In this study, metaphase chromosome spreads were prepared from the bone marrow cells of these animals and scored for chromosomal aberrations. The results revealed that compound FDA 71 -55, tartaric acid, can be considered non-mutagenic as measured by the cytogentic test.