Syrups, wheat, hydrolyzed starch

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

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: 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:

no guideline followed

Principles of method if other than guideline:

Acute IV study

GLP compliance:

no

Remarks:

pre-dates GLP

Limit test:

yes

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:

mouse

Strain:

ICR

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:

intravenous

Vehicle:

water

Details on exposure:

Administered to a groups of 10 mice by changing dose in accordance with the stage of administration.

Doses:

2.1, 3.0, 4.3, 6.0 g/kg body weight or 3.6, 5.0, 7.1, 10.0 ml/kg body weight for males and 3.0, 4.3, 6.0, 8.4 g/kg body weight or 5.0, 7.1, 10.0, 14.1 ml/kg body weight for females

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: general observation

Statistics:

Not required, acute study

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3.22 other: g/kg body weight

95% CL:

>= 2.53 - <= 3.66

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

5.6 other: g/kg body weight

95% CL:

>= 4.87 - <= 645

Mortality:

Females Death rate at 2 minutes: 0/10 at 3.0 g/kg body weight, 1/10 at 4.3 g/kg body weight, 7/10 at 6.0 g/kg body weight, 9/10 at 8.4 g/kg body weight
Male Death rate at 2 minutes: 1/10 at 2.1 g/kg body weight, 4/10 at 3.0 g/kg body weight, 9/10 at 4.3 g/kg body weight, 10/10 at 6.0 g/kg body weight

Clinical signs:

Not reported

Body weight:

Not reported

Gross pathology:

Not reported

Other findings:

Not reported