Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 - 8 September 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles. Body weights were however not recorded throughout the study, which did not influence the reliability of the study.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Body weights were not recorded.
GLP compliance:
yes (incl. QA statement)

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: in addition to diglycerole containing the higher condensated oligomers of glycerol like triglycerol, tetraglycerol and pentaglycerol.
- Purity test date: no data
- Lot/batch No.: 36031195
- Expiration date of the lot/batch: after 2 years (closed bottle, 25°C)
- Stability under test conditions: stable
- Storage condition of test material: ambient

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: E.A. Prinzhorn, Altenbuecken, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually, in a battery of cages (L50 x B45x H40 cm), each equipped with a paper roll disposal system.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
5 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: dressing consisting of Ypsiplast which was held in place by non-irritating tape and Stuelpa which enveloped the whole of the animal's trunk.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean values at 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean values at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean values at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean values at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight to moderate erythema were observed in two animals (between 24 hours and 4 days after treatment in animal no 1 and at 24 - 48 hours in animal no 2).
The observed findings were reversible within 5 days after treatment.
Other effects:
No toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal irritation/corrosion of Polyglycerol-3 was assessed using 3 albino rabbits. The skin was exposed to the test substance for 4 hours. Animals were examined for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after patch removal and thereafter once daily up to day 5. In consequence, slight to moderate erythema was observed but was reversible within 5 days. Based on the mean grades of skin reactions the test substance is considered to be not irritating to skin.