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EC number: 232-452-1 | CAS number: 8031-44-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- The procedure followed for the assessment of eye irritation potential was a modification of that used by Draize et. al. 1944.
Draize, J.H., Woodard, G. and Calvery, H.O. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J.Pharm. & Ex. Ther. 82, 377. - GLP compliance:
- no
- Remarks:
- the study was performed pre-GLP
Test material
- Reference substance name:
- Lanolin, hydrogenated
- EC Number:
- 232-452-1
- EC Name:
- Lanolin, hydrogenated
- Cas Number:
- 8031-44-5
- Molecular formula:
- UVCB: not available
- IUPAC Name:
- Lanolin, wool wax, hydrogenated
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand abino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml. - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- six animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: the treated eyes of all animals remained unwashed.
OBSERVATIONS: observations of injuries were made on the cornea, iris and the bulbar and palpebral conjuctivae. Readings were made 1, 2, 3 days after treatment and up to 7 days when necessary.
SCORING SYSTEM: in this system the injuries to the cornea and iris account for appr. 80 % of the total score.
- Cornea
Opacity (A): Opacity-degree of density (area which is dense is taken for reading)
Scettered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured. 2
Opalescent areas, no details of iris visible, size of pupil barely discenible 3
Opaque, iris invisible 4
Area of cornea involved (B)
One quarter(or less), but not zero 1
Greater than one-quarter, but less than one-half 2
Greater than one-half, but less than three-quarters 3
Greater than three-quarters, up to whole area 4
-Iris
Folds above normal, congestion, swelling, circumcorneal injection(any or all of these
or combinations of any thereof), iris still reacting to light 1
No reaction to light hemorrhage, gross destruction, (any or all of these) 2
-Conjuctivae
Redness (A) - Redness (refers to pelpebral conjuctivae only)
Vessels definetely injected above normal 1
More diffuse, crimson red, individual vessels not easily discernible 2
Diffuse beefy red. 3
Chemosis (B)
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of the lids 2
Swelling with lids about half-closed 3
Swelling with lids about half-closed to completely closed 4
Discharge (C)
Any amount different from normal (does not include small amount observed in inner
canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to the lids 2
Discharge with moistening of the lids and hairs and considerable area around eye 3
TOOL USED TO ASSESS SCORE: hand-held lenses.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: scoring for 72 hrs is not available since the animal died (non dose related cause)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The summarized scores for cornea, iris and conjuctivae are presented in the table below.
Table
| Rabbit no | Day | Cornea | Iris | Conjuctivae | |||
| Opacity | Area | Redness | Chemosis | Discharge | |||
| 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | - | - | - | - | - | - | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
| 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
| 3 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
| 4 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
| 5 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
| 6 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | - | - | - | - | - | - | |
| 7 | - | - | - | - | - | - | |
- = animal death due to non dose-related causes
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as eye irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non-eye irritant
- Executive summary:
The eye irritation potential of the substance to rabbits was evaluated by a procedure followed modification of that used by Draize et. al. 1944. The substance was applied in the right eye of the 6 albino rabbits, while the left eye was left untreated and served as control. The eyes of the animals remained unwashed. Changes in cornea (opacity), iris, conjuctivae (redness, chemosis, discharge) were evaluated and scored at 24, 48, 72 hours and 4 and 7 days following application.
The mean scores following grading at 24, 48 and 72 for cornea opacity, iris and conjuctivae chemosis was 0 for all animals. The mean scores for conjuctivae redness was 0.33 for 5 out of 6 animals. One animal died after 3 days following application while one animal dies after 2 days following application. The deaths were not treatment related.
Based on the scores obtained, the substance is considered as a non-eye irritant.
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