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EC number: 942-425-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 6 to 13, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study comparable to OECD test guideline No. 405 with deviations not affecting the integrity of the result. Even if full reversibility was not achieved for conjunctival reactions within the observation period of 7 days, only minimal responses (score = 1) persisted at the end of the observation period. Complete reversibility would have probably occurred if the observation period was extended to 21 days, as required by the current OECD TG 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- (3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Reference substance name:
- (3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Test material form:
- not specified
- Details on test material:
- - Physical state: no data
- Sample received: 1984-06-04
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, USA
- Housing: Animals were housed individually in stainless steel cages with elevated wire mesh flooring.
- Diet: Wayne 15 % Rabbit Ration, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Animals were acclimated to the laboratory for an appropriate time prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 60-75 °F
- Humidity: 40-45 %
- Photoperiod: 12 h light/12 h dark
IN-LIFE DATES: From: August 6, 1984 To: August 13, 1984
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:
- - Test material was not washed from the eyes of animals.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: According to the 'Draize technique'
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- - Animals showed conjunctival reactions (redness, chemosis and discharge) which were not fully reversible within 7 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) |
||
24 h |
0 |
0 |
0 |
1 |
1 |
1 |
48 h |
0 |
0 |
0 |
1 |
1.17 |
0.5 |
72 h |
0 |
0 |
0 |
1 |
0.83 |
0.17 |
Mean |
0 |
0 |
0 |
1 |
1 |
0.56 |
Reversibility |
- |
- |
- |
Not completely reversible |
Not Completely reversible |
Not Completely reversible |
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) |
||
24 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 /1 / 1 |
1 / 2 / 1 / 1 / 1 / 0 |
0 / 1 / 1 / 2 / 1 / 1 |
48 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 1 |
1 / 2 / 1 / 1 / 1 / 1 |
0 / 1 / 1 / 1 / 0 / 0 |
72 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 1 |
1 / 2 / 1 / 1 / 0 / 0 |
0 / 0 / 0 / 0 / 1 / 0 |
Day 4 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 1 |
1 / 2 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
Day 7 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 0 / 0 |
1 / 1 / 0 / 0 / 0 / 0 |
0 / 1 / 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 / 0 / 0 |
1 / 1 / 1 / 1 / 1 / 1 |
1 / 2 / 1 / 1 / 0.67 / 0.33 |
0 / 0.67 / 0.67 / 1 / 0.67 / 0.33 |
Reversibility |
- |
- |
- |
Not completely reversible |
Not Completely reversible |
Not Completely reversible |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 1 for redness, 1 for chemosis and 0.0 for iris lesions and 0.0 for corneal opacity. Animals showed conjunctival reactions (redness, chemosis and discharge) which were not fully reversible within 7 days.
Even if full reversibility was not achieved for conjunctival reactions within the observation period of 7 days, only minimal responses (score = 1) persisted at the end of the observation period on 4 out of 6 animals. Complete reversibility would have probably occurred if the observation period was extended to 21 days, as required by the current OECD TG 405; Under the test conditions, the test material is not classified as irritating to the eyes according to the Regulation EC No. 1272/2008 (CLP) and to the GHS. - Executive summary:
In an eye irritation study performed according to US-FHSA method, 0.1 mL of undiluted test material was instilled into the conjunctival sac of one eye of 6 New Zealand White rabbits while the remained untreated eye served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on Days 4 and 7. 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 each animal within 3 scoring times (24, 48 and 72 h) were 1 for redness, 1 for chemosis and 0.0 for iris lesions and 0.0 for corneal opacity. Animals showed conjunctival reactions (redness, chemosis and discharge) which were not fully reversible within 7 days.
Even if full reversibility was not achieved for conjunctival reactions within the observation period of 7 days, only minimal responses (score = 1) persisted at the end of the observation period on 4 out of 6 animals. Complete reversibility would have probably occurred if the observation period was extended to 21 days, as required by the current OECD TG 405; Under the test conditions, the test material is not classified as irritating to the eyes according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute eye irritation endpoint.
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