Oligomerisation products of sucrose with ethylene oxide and methyloxirane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Test animals: Wistar rats (Crl:WI (Han) SPF)
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- 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
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: about 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage (Fixomull® Stretch (adhesive fleece))

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 5000 mg/kg bw (4.31 mL/kg bw)

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

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. Individual skin readings were performed 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Other findings:

No other findings were observed.