Pigment Yellow FC 26290

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Principles of method if other than guideline:

The micronucleus test was employed to investigate Pigment Yellow Fe 26290 in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts.

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

content: 83.9% (free acid), 7% H20, 6.3% Ca, 0.2% Na

Test animals

Species:

mouse

Strain:

other: Bor: NMRI

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Duration of treatment / exposure:

The femoral marrow of groups treated with Pigment Yellow FC 26290 was prepared 16, 24 and 48 hours after administration

Frequency of treatment:

single application

Post exposure period:

SACRIFICE TIME
1) 0 mg/kg - 24 h; 600 mg/kg - 16 h; 600 mg/kg - 24 h; 600 mg/kg - 48 h
2) 0 mg/kg - 24 h; 300 mg/kg - 24 h; 500 mg/kg - 24 h; 700 mg/kg - 24 h

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
T 9041202: 600 mg/kg body weight
Basis:
nominal conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
T 2041331: 300, 500 and 700 mg/kg body weight
Basis:

No. of animals per sex per dose:

Each group comprised ten mice, five males and five females

Control animals:

yes, concurrent vehicle

Examinations

Tissues and cell types examined:

bone-marrow erythroblasts

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

All animals treated with Pigment Yellow FC 26290 showed symptoms of toxicity after administration. All animals treated with doses up to and including 600 mg/kg survived until the end of the test. However, two of twenty animals died before the end of the second test due to the acute intraperitoneal toxicity of 700 mg/kg Pigment Yellow FC 26290. Both experiments showed an altered ratio between polychromatic and normochromatic erythrocytes.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative

Executive summary:

The micronucleus test was employed to investigate Pigment Yellow FC 26290 in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts. The known clastogen and cytostatic agent, cyclophosphamide, served as positive control.

Two experiments were performed. The animals of the first experiment received a single intraperitoneal administration of either Pigment Yellow FC 26290 or cyclophosphamide. The femoral marrow of groups treated with Pigment Yellow FC 26290 was prepared 16, 24 and 48 hours after administration. All negative and positive control animals were sacrificed after 24 hours. The doses of Pigment Yellow FC 26290 and the positive control, cyclophosphamide, were 600 and 20 mg/kg body weight, respectively. The animals of the second experiment received also a single intraperitoneal administration of either Pigment Yellow FC 26290 or

cyclophosphamide. The femoral marrow of all groups was prepared 24 hours after administration. The doses of Pigment Yellow FC 26290 were 300, 500 and 700 mg/kg body weight, respectively. other conditions remained unchanged.

All animals treated with Pigment Yellow Fe 26290 showed symptoms of toxicity after administration. All animals treated with doses up to and including 600 mg/kg survived until the end of the test. However, two of twenty animals died before the end of the second test due to the acute intraperitoneal toxicity of 700 mg/kg Pigment Yellow FC 26290.

Both experiments showed an altered ratio between polychromatic and normochromatic erythrocytes.

The combined results of both experiments gave no relevant indications of a clastogenic effect of Pigment Yellow FC 26290 after a single intraperitoneal treatment with doses up to and including 700 mg/kg body weight.