Oligomerisation products of sucrose with ethylene oxide and methyloxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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:

Oligomerisation products of sucrose with ethylene oxide and methyloxirane

EC Number:

701-303-7

Molecular formula:

C12 H14O11. ( C3 H6 O )(b+d+f+h+j+l+n+p).(C2 H4 O)(a+c+e+g+i+k+m+o) ; 1 < a+c+e+g+i+k+m+o < 16.5; 1 < b+d+f+h+j+l+n+p < 16.5

IUPAC Name:

Oligomerisation products of sucrose with ethylene oxide and methyloxirane

Details on test material:

- Name of test material (as cited in study report): Sucrose, ethoxylated and propoxylated (>1 < 16.5 mol EO and >1 < 16.5 mol PO)
-Test item number: 11/0043-1
- Physical state: Liquid, viscous / colorless, clear
- Analytical purity: >99%
- Lot/batch No.: T35/035/10
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature, protect against humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: 16 hours
- Housing: single housing in Makrolon cages (Type III)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.73 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Administration 1: 3 females
Administration 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs was performed several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: A check for any dead or moribund animals was made at least once each workday.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Effect levels 2

Sex:

female

Dose descriptor:

other: LD50 (predicted)

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According to OECD TG 423 (adopted 2001), Annex 2d

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Other findings:

No other findings were observed.