Registration Dossier
Registration Dossier
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EC number: 915-741-3 | CAS number: 25618-55-7
Eye irritation
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:
- 1 996
- 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
- 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
Constituent 1
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.
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