Oligomerisation products of sucrose with ethylene oxide and methyloxirane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in accordance to GLP and OECD guideline 429.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose, propoxylated

EC Number:

500-029-3

EC Name:

Sucrose, propoxylated

Cas Number:

9049-71-2

Molecular formula:

C12H14O11-(C3H6O)nH8 sum of n: >1 - <16.5 mol PO

IUPAC Name:

Sucrose, propoxylated

Details on test material:

Test substance: Desmophen VP.PU 90AP90, Supplier: Bayer AG
alpha.-D-Glucopyranoside, beta.-D-fructofuranosyl, polymer with 1,2-ethanediol and methyloxirane CAS No.103513-09-3
Average molecular weight and detailed composition might not be provided in the report but was confirmed with the supplier for the purpose of this summary.
Average molecular weight: 580 g/mol
Straw coloured viscous liquid; purity not reported
Lot No. 0235
Composition:
76 %b.w. Sucrose-PO polyether
16 %b.w. MPG-PO polyether
8 %b.w. MEG-PO polyether

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Ltd, Staffs, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23g

Study design: in vivo (non-LLNA)

Induction

Vehicle:

other: acetone/olive oil 4:1

Challenge

Vehicle:

other: acetone/olive oil 4:1

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

5/mice/group were treated with the test material at concentrations of 0.5%, 5% or 50% w/v in acetone/olive oil 4:1

No. of animals per dose:

5/mice/group

Details on study design:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT

Five days following the first topical application of the test material (Day 5) all mice were injected via the tail vein with 250 µl of phosphate buffered saline containing 3 H-methyl thymidine (3HTdR:80µCi/ml, specific activity 2.0 Ci/mmol) giving a total of 20 µCi to each mouse.

The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph nodes from each individual animal and as the ratio of 3 HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index (SI)).

TREATMENT PREPARATION AND ADMINISTRATION:
The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 0, 1, 2).

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

other: Eugenol... (see attached file)

Statistics:

Linear regression analysis followed by one way analysis of variance (ANOVA) incorporating Levene’s test for homogeneity of variance. Where variances were shown to be homogenous pairwise comparisons were conducted using Dunnett’s test. Where Levene’s test showed unequal variances the data were analysed using non-parametric methods: Kruskal-Wallis ANOVA and Mann-Whitney ’U’ test.

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: Proliferative Response of Lymph Node Cells: A stimulation index (SI) of less than 3 was recorded for the three concentrations of the test material SI of the 0.5% group: 1.07 SI of the 5% group: 1.03 SI of the 50% group: 0.84

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.