Syrups, corn, hydrogenated

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

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

- details on housing/feeding not provided.

GLP compliance:

no

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Syrups, corn, hydrogenated

EC Number:

270-337-8

EC Name:

Syrups, corn, hydrogenated

Cas Number:

68425-17-2

Molecular formula:

UVCB substance: not applicable

IUPAC Name:

Syrups, hydrolyzed starch, hydrogenated

Details on test material:

- Name of test material (as cited in study report): Lycasin 80/55
- Physical state: Colourless viscous liquid

Test animals

Species:

mouse

Strain:

other: - Swiss Carworth Farm Lane-Petter

Sex:

male

Details on test animals or test system and environmental conditions:

Details were not provided. Animals weighed between 25 and 30 g and, during the test, had access to water and food.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: Permuted water.

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: Lycasin was diluted in permuted water at the concentration of 0.2 mL/mL for administration to the low-dose group (5 mL/kg bw); undiluted Lycasin was administered to the high-dose group (25 mL/kg bw).

Duration of treatment / exposure:

48 hours.

Frequency of treatment:

One dose/day with sacrifice occurring 6 hours after the second administration.

Post exposure period:

6 hours after the second of 2 daily doses.

Doses / concentrations

Remarks:

Doses / Concentrations:
5 and 25 mL/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Positive control(s):

Urethane
- Route of administration: Oral gavage.
- Doses / concentrations: 2 g/kg bw administered as a solution at 80 mg/mL

Examinations

Tissues and cell types examined:

Bone marrow from femurs.

Details of tissue and slide preparation:

After centrifugation, the bone marrow is homogenized and one drop is smeared on a slide. The smear is dried and coloured with May-Grunwald-Giemsa.

Evaluation criteria:

Evaluation was based on the results of the student's t-test.

Statistics:

Student's t-test.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

yes

Remarks:

- one male in the high-dose group died after administration of the second dose. No other toxicity was reported.

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Products	Doses	Number of Mice	Percentage of erythrocytes with micronuclei
Permuted water	-	10	0.10 ± 0.03
Lycasin	5 mL/kg	10	0.12 ± 0.05
Lycasin	25 mL/kg	9	0.15 ± 0.05
Urethane	2 g/kg	10	5.76 ± 0.75

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative