Caramel (color)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

GENOTOXICITY HAZARD ASSESSMENT OF CARAMEL COLOURS III AND IV

Author:

BRUSICK D.J. et al.

Year:

1992

Bibliographic source:

Fd Chem. Toxic. Vol. 30, No. 5, pp. 403-410, 1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

no

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Caramel (color)

EC Number:

232-435-9

EC Name:

Caramel (color)

Cas Number:

8028-89-5

Molecular formula:

C6H12OH

IUPAC Name:

Caramel

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

Adult male and female CD-1 mice were purchased from Charles River Breeding Laboratories, Inc. (Portage, MI, USA) and were fed a commercial diet (Purina Laboratory Chow) and offered water ad lib.

Administration / exposure

Route of administration:

oral: gavage

Details on exposure:

Treatments were delivered by gavage in volumes of 0.20ml (males) or 0.18 ml (females) in two administrations, 24 hr apart.

Duration of treatment / exposure:

not indicated

Frequency of treatment:

Two administrations, 24 hr apart.

Post exposure period:

6 hr after the last dose, the animals were killed.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1.05 mg/kg bw/day

Remarks:

low dose

Doses / concentrations 2

Dose / conc.:

3.5 mg/kg bw/day

Remarks:

high dose

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

yes

Positive control(s):

Triethylenemelamine and sodium ascorbate

Examinations

Tissues and cell types examined:

Bone marrow (tissue) and polychromatic erythrocytes (cell types).

Details of tissue and slide preparation:

Both tibiae were removed, and marrow was flushed into centrifuge tubes containing FCS. Following centrifugation, the supernatant was drawn off, cells were resuspended in a drop of serum and spread on slides, and preparations were airdried, fixed in methanol, stained in May-Gruenwald solution followed by Giemsa, and rinsed in deionized water (Schmid, 1975). 500 polychromatic erythrocytes (PCE) per animals were scored under blind code.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The level of micronuclei at the high dose was increased over that of the control groups but it was not statistically significant. The level of micronuclei was significantly increased in the group fed sodium ascorbate and TEM (positive controls).

Applicant's summary and conclusion

Conclusions:

In an in vivo micronucleus assay, caramel E150 class III did not induce any statistically significant micronuclei.