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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 August - 9 September 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
we have used Acceptable guinea pig maximisation test that followed sound scientific principles.

Test material

Constituent 1
Reference substance name:
Polyglycerol-3
IUPAC Name:
Polyglycerol-3
Details on test material:
- Name of test material (as cited in study report): Polyglycerol-3
- Substance type: yellowish, clear, viscous liquid
- Physical state: liquid
- Analytical purity: active compound 100%
- Composition of test material, percentage of components:
approx.
43% polyglycerin-3
27% polyglycerin-2
16% polyglycerin-4
14% polyglycerin-5-8
- Purity test date: no data
- Lot/batch No.: 36031195
- Expiration date of the lot/batch: after 3 years (closed bottle, 25°C)
- Stability under test conditions: stable
- Storage condition of test material: ambient

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white, Hsd/Poc: DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 421-499 g, females: 358-516 g
- Housing: collective housing up to maximum of 10 animals per cage in a battery of cages, each equipped in a paper roll disposal system
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: range finding 7 days, main test 16 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: aqua ad iniect. for intradermal test
Concentration / amount:
intradermal: 5% in aqua ad iniect.
epidermal: undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: aqua ad iniect. for intradermal test
Concentration / amount:
intradermal: 5% in aqua ad iniect.
epidermal: undiluted
No. of animals per dose:
20 test, 10 controls
Details on study design:
RANGE FINDING TESTS:
Intradermal injection: the test substance was diluted with aqua ad iniect. and FCA to give a final concentration of 5%. Two animals were employed, skin reactions were recorded 48 h after treatment.
Dermal application: the test substance was undiluted. A closed patch exposure was effected by means of an occlusive bandage and non-irritating tape, which enveloped the whole animal's trunk. Two animals were employed and skin reactions were recorded 48 h after treatment.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (on either side of the spine)
- Exposure period: 1st day intradermal injection, 7th day dermal application.
- Test groups:
1. 0.1 ml FCA 50% (v/v) diluted in aqua ad iniect.
2. 0.1 ml test substance diluted aqua ad iniect. (final concentration 5%)
3. 0.1 ml test substance diluted in FCA/aqua ad iniect. (final concentration 5%)
- Control group:
1. 0.1 ml FCA 50% (v/v) diluted in aqua ad iniect.
2. 0.1 ml aqua ad iniect.
3. 0.1 ml aqua ad iniect. 50% (v/v) diluted in FCA
- Site: shoulders, sides of the spine
- Duration: epicutaneous application 48 h


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the second stage of induction
- Exposure period: 24h
- Test groups: undiluted (left flank) and aqua ad iniect. (right flank)
- Control group:
- Site: flanks
- Evaluation (hr after challenge): 24 and 48 h after patch removal


OTHER: 24h before dermal application, 10% SLS in vaseline was applied to induce a mild inflammation.
Positive control substance(s):
yes
Remarks:
4-aminobenzoic acid ethyl esther (benzocaine)

Results and discussion

Positive control results:
Induction:
intradermal and dermal test - benzocaine
control - peanut oil / vaseline

Challenge exposure: benzocaine, 25% and 10 % in vaseline.

Results:
sensitization rate at concentration 25% at 24 h: 40%
sensitization rate at concentration 25% at 48 h: 30%

sensitization rate at concentration 10% at 24 h: 0%
sensitization rate at concentration 10% at 48 h: 0%

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The potential skin sensitizing properties of Polyglycerol-3 were assessed in the guinea pig maximization test using 20 test and 10 control animals. After induction exposure (concentration 5%) to the test substance the animals were subjected two weeks later to a challenge exposure (undiluted Polyglycerol-3). The treated skin areas were evaluated 24 and 48 hours after the end of exposure period. No skin reactions caused by the test substance were observed (the sensitization rate at 24 and 48 hours was 0%). Since no animals showed an allergic response, the test substance is considered to be not sensitising.