Registration Dossier
Registration Dossier
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EC number: 203-935-4 | CAS number: 112-11-8
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:
- key study
- Study period:
- 23 Jan - 30 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable deviation (no analytical purity of the test item given).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl isodecanoate
- EC Number:
- 269-023-3
- EC Name:
- Isopropyl isodecanoate
- Cas Number:
- 68171-33-5
- IUPAC Name:
- 68171-33-5
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: very light yellow liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ELEVAGE DES FEUILLETAS (40 - CAMPET LAMOLERE)
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually in stainless steel cages (61 x 46 x 34 cm) with a grid floor
- Diet: UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- 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(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: the test item was not washed out.
SCORING SYSTEM: Draize scoring system.
TOOL USED TO ASSESS SCORE: Electric lamp and ophthalmoscope were used for examination of the iris. For detection of cornea lesions, fluorescein sodium solution was used.
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 hours
- 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 hours
- 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 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritant / corrosive response data:
- Slight conjunctival redness with slight chemosis and lacrimation graded 2 to 3 were seen in all 3 animals at reading time point 1 h. Slight redness persisted in 2 cases until reading time point 24 h.
Any other information on results incl. tables
Table 1: Evaluation of the eye reaction
Rabbit No. |
Reading time |
Conjunctiva |
Iris |
Cornea |
||
Chemosis |
Lacrimation |
Redness |
||||
1 |
1 h |
1 |
3 |
1 |
0 |
0 |
24 h |
0 |
0 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
|
Mean1 |
0 |
0 |
0.33 |
0 |
0 |
|
2 |
1 h |
1 |
3 |
1 |
0 |
0 |
24 h |
0 |
0 |
1 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
|
Mean1 |
0 |
0 |
0.33 |
0 |
0 |
|
3 |
1 h |
1 |
2 |
1 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
|
Mean1 |
0 |
0 |
0 |
0 |
0 |
|
Mean1= Mean over 24, 48 and 72 hours
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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