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Registration Dossier
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EC number: 265-779-3 | CAS number: 65443-14-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 23 to 26, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to standard guideline with the following deviations: 6 animals tested instead of 3. This deviation does not affect the reliability of this study.
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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals tested
- Principles of method if other than guideline:
- Study was performed according to modified Draize procedure (Draize, 1975).
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
Test material
- Reference substance name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- EC Number:
- 265-779-3
- EC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Cas Number:
- 65443-14-3
- Molecular formula:
- C13H24O
- IUPAC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): PD 309-8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: About 3 months
- Weight at study initiation: Approximately 2 kg
- Housing: Animals were housed in galvanized or stainless steel cages.
- Diet: Diet consisted of a growth and maintenance ration from a commercial producer, ad libitum
- Water, ad libitum
- Acclimation period: 3 days
IN-LIFE DATES: From: July 23, 1979 To: July 26, 1979
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 eyes of all animals remained unwashed for 24 h.
- Observation period (in vivo):
- 24, 48, and 72 h 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: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #4 & #6
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4 & #6
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3 & #5
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Animals showed conjunctival reactions (redness and chemosis) which were reversible within 2 days
- Other effects:
- -None
Any other information on results incl. tables
Table 7.3.2/1: 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 (Day 1) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 1 / 1 / 1 / 0 / 1 |
0 / 0 / 0 / 1 / 0 / 1 |
0 / 0 / 0 / 0 / 0 / 0 |
48 h (Day 2) |
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 |
72 h (Day 3) |
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 24h, 48h, and 72h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0.33 / 0.33 / 0.33 / 0.33 / 0 / 0.33 |
0 / 0 / 0 / 0.33 / 0 / 0.33 |
0 / 0 / 0 / 0 / 0 / 0 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
- |
Average time (unit) for reversion |
- |
- |
- |
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 induced slight irritation being reversible within 2 days. Therefore, the test material is not classified as irritant to the eyes according to the Annex VI of the Regulation (EC) No. 1272/2008.
- Executive summary:
In an eye irritation study, 0.1 mL of undiluted test material was instilled into the one eye of 6 albino rabbits while the contralateral eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. 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 each animal within 3 scoring times (24, 48 and 72 h) were 0.33/0.33/0.33/0.33/0.00/0.33 for redness, 0.00/0.00/0.00/0.33/0.00/0.33 for chemosis, and 0/0/0/0/0/0 for iris lesions and corneal opacity. The conjunctival reactions were fully reversible within 2 days.
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).
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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