Registration Dossier
Registration Dossier
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EC number: 247-568-8 | CAS number: 26266-57-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 26 Feb - 04 March 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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)
- Remarks:
- Ministerium für Umwelt, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Sorbitan, octanoate (2:3)
- EC Number:
- 295-118-4
- EC Name:
- Sorbitan, octanoate (2:3)
- Cas Number:
- 91844-53-0
- IUPAC Name:
- 91844-53-0
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan-octanoate(2:3)
- Substance type: organic
- Physical state: amber viscous liquid
- Analytical purity: 100%
- Lot/batch No.: ES66941443
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Weight at study initiation: 2,053.8 g and 2,155.2 g (female), 1,805.8 g (male)
- Housing: Single in steel cages with a plastic bottom mould and a habitat of 5445 square centimetres at the bottom and an overall height of 600 millimetres. A non-barrier system with air conditioning was used.
- Diet: Food type “2023" from Altromin International, Lage, Germany as pelleted diet (Batch No.: 1105; expiry date: 2008-09-03), ad libitum.
- Water: Drinking water consisted of normal tap water from municipal source (SWK AQUA GmbH, Krefeld, Germany), ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr): 8 times/h
- Photoperiod (hrs dark / hrs light): dimmed light, no further data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 mL / 100%
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with saline solution
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guideline
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: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- All 3 animals showed slight ocular reaction 1 h after application of the test substance (one score each for conjunctivae redness, chemosis and discharge at three animals and one score for slight reaction of the iris at one animal). 24 h after application slight redness and chemosis was still observed in all three animals. 7 days after application all three animals were without any sign of ocular irritation. Cornea damage was not observed at any time during the study.
Any other information on results incl. tables
Table 1: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 1.
Animal #1 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
1 |
1 |
0 |
1 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
Table 2: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 2.
Animal #2 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
1 |
0 |
0 |
0.67 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
Table 3: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 3.
Animal #3 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
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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