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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11-16 September 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles. Although the study followed the old revised OECD guideline, the study is considered reliable.

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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 component 100%
- Composition of test material, percentage of components: in addition to diglycerol it contains in particular the higher condensated oligomers of glycerol (triglycerol, tetraglycerol and pentaglycerol)
- Lot/batch No.: 3603 1195
- 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: E.A. Prinzhorn, Altenbruecken, Germany
- Age at study initiation: not indicated
- Weight at study initiation: not indicated
- Housing: individually in a battery of cages (50x45x40 cm) each equipped with paper roll disposal system.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: not indicated


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The treated eye was not rinsed.
Observation period (in vivo):
until 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 2 and 3
Time point:
other: 24-72h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 1and 2
Time point:
other: mean values of 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: slight ocular secretion was observed and fully reversible within 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Slight ocular secretion was observed and fully reversible within 48h
Irritant / corrosive response data:
The test substance does not have to be classified as irritant when administrated to the eye of a rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The potential toxicity of Polyglycerol-3 was assessed in acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1 ml of the test substance was instilled into the conjunctival sac of one eye. The eyes were examined at 1, 24, 48 and 72 hours after application. Slight to moderate redness and swelling of the conjunctival sac as well as slight ocular secretion were noticed but reversible within 48 hours. No toxic effects were observed. The test substance is considered to be non-irritating to the eyes.