Syrups, wheat, hydrolyzed starch

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)

Deviations:

yes

Remarks:

- lacking methodological detail, fewer than 30 females used per dose level, & no positive or vehicle control for subacute test.

GLP compliance:

no

Remarks:

- study pre-dates GLP.

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

Reference substance name:

D-glucitol

EC Number:

200-061-5

EC Name:

D-glucitol

Cas Number:

50-70-4

IUPAC Name:

D-glucitol

Details on test material:

- Name of test material (as cited in study report): Sorbitol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Assigned to test groups randomly: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

A control group received 10 mL/kg; however, the vehicle that this group received was not reported.

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: Not reported

Duration of treatment / exposure:

Acute = single administration.
Subacute = once/day for 5 days.

Frequency of treatment:

Acute = single administration.
Subacute = once/day for 5 days.

Post exposure period:

Acute = 8 weeks.
Subacute = 7 weeks.

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 30, 2500, or 5000 mg/kg bw
Basis:
actual ingested
- for both acute and subacute studies.

No. of animals per sex per dose:

Acute = 16-20 pregnant females (number of males not reported).
Subacute = 17-20 pregnant females (number of males not reported).

Control animals:

yes

Positive control(s):

triethylenemelamine
- Doses / concentrations: 0.2 mg/kg bw

Examinations

Details of tissue and slide preparation:

Not reported

Evaluation criteria:

Not reported

Statistics:

Chi square test and Armitage test.

Results and discussion

Test results

Sex:

female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

It should be noted that neither vehicle nor positive controls were used in the subacute study.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative