Syrups, wheat, hydrolyzed starch

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

purity, source and physio-chemical properties of substance not reported; animal housing information not reported.

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

standard acute method

Limit test:

no

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
- Physical state: solid (powder)
- Analytical purity: not reported (60% w/v solution with distilled water)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: 5 weeks
- Weight at study initiation: 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


IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE
-Quantity of solution: 56.6, 40.0, 28.3, or 20.0 ml/kg
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported


MAXIMUM DOSE VOLUME APPLIED: Not reported.


CLASSIC METHOD
- Rationale for the selection of the starting dose: Not reported

Doses:

12, 17, 24, 34 g/kg or 20, 28.3, 40.0, 56.6 ml/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: Not reported

Statistics:

Acute study, not required

Results and discussion

Preliminary study:

Not reported

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

20.2 other: g/kg

95% CL:

>= 18.4 - <= 22.2

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

18.9 other: g/kg

95% CL:

>= 16.3 - <= 21.7

Mortality:

Male death rate at 1 day: 10/10 at 34.0 g/kg, 9/10 at 24.0 g/kg, 1/10 at 17.0 g/kg 0/10 at 12.0 g/kg
Female death rate at 1 day: 10/10 at 34.0 g/kg, 8/10 at 24.0 g/kg, 4/10 at 17.0 g/kg, 0/10 at 12.0 g/kg

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Other findings:

Not reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP EC 1272/2008