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EC number: 209-097-6 | CAS number: 555-43-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Apr - 27 Apr 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Glycerol tristearate
- EC Number:
- 209-097-6
- EC Name:
- Glycerol tristearate
- Cas Number:
- 555-43-1
- Molecular formula:
- C57H110O6
- IUPAC Name:
- 1,3-bis(octadecanoyloxy)propan-2-yl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Chemical identity: glycerol tristearate
- Physical state: white, homogeneous powder
- Analytical purity: 98%
- Purity test date: June 17th, 1996
- Batch No.: 512014
- Date of production: January 29th, 1996
- Stability under test conditions: > 3 years
- Storage condition of test material: in tightly closed containers under exhaust hood
- Solubility (20 °C): practically insoluble in water
- Density (20°C): about 0.95 g/cm³
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian, Mol. Russian, Chbb:MH
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding & Research Center Ltd., Lille Skensved, Denmark
- Age at study initiation: adult animals
- Weight at study initiation: 2.2, 2.4 and 2.4 kg (animals #1, 2 and 3, respectively)
- Housing: conventional, single housing in stainless steel cages
- Diet: Ssniff K 4 complete feed for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 6 days
Reading time points: 1, 24, 48 and 72 h and 6 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes were were rinsed with warm physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 1 h post-instillation: some definitely hyperaemic (injected) blood vessels in 1 animal, diffuse, crimson red coloured mucous membranes (individual vessels were not easily discernible) in 2 animals. Swelling above normal of lids (and nictating membranes) and discharge in form of white mucous were observed in all 3 animals.
24-72 h post-instillation: the conjunctivae of all 3 animals still showed some definitely hyperaemic blood vessels.
6 days post-instillation: no more irritations on eye and mucous membrane were observed in any animal.
During the whole observation period, cornea and iris of all animals were free of any irritations. - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Summary of results.
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
|
redness |
swelling |
||||
1 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.0 |
0.0 |
0.0 |
0.0 |
|
2 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.0 |
0.0 |
0.0 |
0.0 |
|
3 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.0 |
0.0 |
0.0 |
0.0 |
|
|
|
|
|
|
|
|
Time [h] |
conjunctivae |
iris |
cornea |
|
|
redness |
swelling |
|||
average score |
1 |
1.66 |
1.00 |
0.00 |
0.00 |
24 |
1.00 |
0.00 |
0.00 |
0.00 |
|
48 |
1.00 |
0.00 |
0.00 |
0.00 |
|
72 |
1.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
1.00* |
0.00 |
0.00 |
0.00 |
|
* On Day 6 post-instillation, the conjuctival redness score was 0 in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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