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EC number: 942-400-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 02 to December 14, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to the Draize procedure which is similar to the current OECD Test Guideline No. 405.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study was performed according to modified Draize procedure (Draize, 1944).
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
Test material
- Reference substance name:
- Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE
- Molecular formula:
- C12H18O
- IUPAC Name:
- Reaction mass of (+-)-(1RS,2SR,5SR,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE and (+-)-(1RS,2SR,5RS,7RS,8SR)-5-METHYLTRICYCLO[6.2.1.02,7]UNDECAN-4-ONE
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): 5. 0878/2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Weight at study initiation: 1.8-2.4 kg
- Diet: Wayne animal feed, ad libitum
- Water: Water, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 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:
- The treated eyes of all animals remained unwashed for 24 h.
- Observation period (in vivo):
- Days 1, 2 and 3 following instillation of the test material.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: According to Draize scale.
TOOL USED TO ASSESS SCORE: Readings were facilitated by hand-held lenses.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- - Animals showed weak conjunctival reactions (redness and chemosis) which were reversible within 2 days.
- One animal showed iris reaction of grade 1 which was reversible within 2 days. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Mean eye irritation response data of 6 animals at each observation time
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
Day 1 (24 h) |
0 |
0 |
0.17 |
0.83 |
0.5 |
0.17 |
Day 2 (48 h) |
0 |
0 |
0 |
0 |
0 |
0 |
Day 3 (72 h) |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
0 |
0 |
0.06 |
0.28 |
0.17 |
0.06 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time for reversion |
- |
- |
- |
2 days |
2 days |
2 days |
Table 7.3.2/2: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
Day 1 (24 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 0 |
1 / 1 / 0 / 1 / 0 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
Day 2 (48 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Day 3 (72 h) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Average 24, 48 and 72 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0.33 / 0 / 0 |
0.33 / 0.33 / 0.33 / 0.33 / 0.33 / 0 |
0.33 / 0.33 / 0 / 0.33 / 0 / 0 |
0 / 0 / 0 / 0.33 / 0 / 0 |
Reversibility |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
- |
- |
2 days |
2 days |
2 days |
2 days |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
- Executive summary:
In an eye irritation study performed according to the Draize procedure which is similar to the current OECD Test Guideline No. 405, 0.1 mL of undiluted test material was instilled into the right eye of 6 New Zealand White rabbits while the left eye remained untreated and served as control. The treated eyes of all animals remained unwashed for 24 h. Animals were observed at 24, 48 and 72 after instillation of test material into eyes. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize Scale.
The calculated mean score for all animals within 3 scoring times (24, 48 and 72 h) were 0.28 for redness, 0.17 for chemosis, 0.06 for iris lesions and 0.0 for corneal opacity. The observed conjunctival reactions and iris lesion (max. score = 1) were fully reversible within 48 hours.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
Although some details on experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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