oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan-Mar 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-690-8

EC Name:

-

Cas Number:

738602-93-2

Molecular formula:

not applicable for UVCB

IUPAC Name:

(2R,3R,4S,5S,6R)-2-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2S,3R,5R)-4-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3I021
- Purity, including information on contaminants, isomers, etc.: approx 72.5% solid content

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C in dry conditions
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: not stated but assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not stated but assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no solvent/ vehicle used
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no reactivity assumed

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
no treatment

FORM AS APPLIED IN THE TEST (if different from that of starting material)
same as received

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (not applicable)
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: not stated
- Rationale for use of males (if applicable)
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: mean 191 g
- Fasting period before study: no
- Housing: in groups of 3
- Historical data: not stated
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Microbiological status when known not stated
- Method of randomisation in assigning animals to test and control groups
selected by hand at time of delivery, no computer generated randomization program

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20. Jan 2004 (delivery of animals) To: 12 February 2004

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2759 g/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: the vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): not applicable
- Purity: purified water prepared at RCC Ltd using PURELAB Option-R unit.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no toxicity was expected for the substance at the 2000 mg/kg bw dose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

according to Guideline

Statistics:

none

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

other: no clinical signs noted

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of MG-60 after single oral administration to female rats, observed over a period of 14 days is:
LD50 greater than 2000 mg/kg bw (solid content)