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EC number: 448-300-4 | CAS number: 88642-03-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-12-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo study on eye irritation/corrosion with the registration substance was completed in 2004. Therefore, in compliance with Regulation (EC) 1907/2006 (REACH) performing an additional in vitro eye irritation/corrosion study is considered scientifically not necessary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 448-300-4
- EC Name:
- -
- Cas Number:
- 88642-03-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- (6E)-cyclohexadec-6-en-1-one; (7Z)-cyclohexadec-7-en-1-one; (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 d
ENVIRONMENTAL CONDITIONS
- Temperature: 20+/- 3 °C
- Humidity: 30 - 70 %
- Air changes: not specified
- Photoperiod: 12/12 hrs dark / hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to the guideline:
CORNEA (Opacity: degree of density (area most dense taken for reading))
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of Iris visible, size of pupil barely discernible
4 opaque cornea, iris not discernible through the opacity
IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection; iris reactive to light (a sluggish reaction is considered to be an effect)
2 haemorrhage, gross destruction, or no reaction to light
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
0 blood vessels normal
1 some blood vessels hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse beefy red
Chemosis: Swelling (refers to lids and/or nictitating membranes)
0 normal
1 some swelling above normal
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
Any other information on results incl. tables
Table 1 - Eye irritation scores of the right eye of treated animals (animal number 1 / 2 / 3)
Time after administration |
Cornea (opacity) |
Iris |
Conjunctiva (redness) |
chemosis |
Before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
1 h |
0/0/0 |
0/0/0 |
2/2/2 |
1/1/1 |
24 h |
1/1/2 |
1/1/1 |
2/2/2 |
1/2/1 |
48 h |
0/0/1 |
0/0/1 |
1/2/2 |
0/2/1 |
72 h |
0/0/0 |
0/0/0 |
0/1/1 |
0/1/1 |
4 d |
-/0/0 |
-/0/0 |
-/1/1 |
-/1/1 |
5 d |
-/0/0 |
-/0/0 |
-/1/1 |
-/1/1 |
6 d |
-/0/0 |
-/0/0 |
-/0/0 |
-/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item was irritating the eye.
- Executive summary:
A study according to OECD 405 was conducted with the test item. A single instillation of 0.1 mL per animal into the conjuncitval sac of the right eye of three rabbits caused the follwoing changes:
Corneal opacity was observed in all animals:
animal nos. 1 and 2: 24 hours (grade 1) after instillation;
animal no. 3: 24 hours (grade 2) and 48 hours (grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal nos. 1 and 2 (1/4 of the surface) and animal no. 3 (1/2 of the surface).
Irritation of the iris (grade 1) was observed in all animals 24 hours, in animal no. 3 until 48 hours after instillation.
Conjunctival redness (grade 1 or 2) was observed in all animals 60 minutes to 48 hours, in animal nos. 2 and 3 until 5 days after instillation.
Conjunctival chemosis (grade 1 or 2) was observed in all animals 60 minutes to 24 hours, in animal nos. 2 and 3 until 5 days after instillation.
There were no systemic intolerance reactions.
Based on the results, the test item is considered to be not irritating to the eye.
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