Registration Dossier
Registration Dossier
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EC number: 273-114-3 | CAS number: 68938-07-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study following standard guidelines and performed following GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Neodecanoic acid
- EC Number:
- 248-093-9
- EC Name:
- Neodecanoic acid
- Cas Number:
- 26896-20-8
- Molecular formula:
- C10H20O2
- IUPAC Name:
- neodecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Versatic 10
- Substance type: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2120-2350 g
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 62.5 - 75
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): n/a - Duration of treatment / exposure:
- Material was instilled into the eye and held shut for one second
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h after treatment
- Number of animals or in vitro replicates:
- 2 rabbit
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hour average
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: edema
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hour average
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
| Corneal Effects | Iris | Conjunctivae | Discharge | |||
| Animal | score | area | redness | swelling | ||
| 1 hour | ||||||
| 1 | 0 | 0 | 1 | 1 | 2 | 2 |
| 2 | 0 | 0 | 0 | 1 | 1 | 1 |
| 3 | 0 | 0 | 0 | 1 | 1 | 1 |
| 24 hours | ||||||
| 1 | 0 | 0 | 0 | 1 | 1 | 0 |
| 2 | 0 | 0 | 0 | 1 | 1 | 0 |
| 3 | 0 | 0 | 0 | 1 | 1 | 0 |
| 48 hours | ||||||
| 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 |
| 72 hours | ||||||
| 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Average | 0 | 0 | 0 | 0.67 | 0.33 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- Versatic 10 was slightly, but transiently, irritating to the rabbit eye.
- Executive summary:
Versatic 10 (neodecanoic acid) was tested for eye irritancy in one eye of each of three rabbits. Eye responses were scored at 1, 24, 48, and 72 hours after treatment according to the method of Draize. At 1 hour after treatment, animals showed slight redness of the conjunctivae, slight to moderate swelling and slight to moderate discharge. One animal showed slight iritis. In all animals, recovery was advanced by 48 hours after treatment and the remaining eye responses had resolved completely by 72 hours after treatment. The overall mean scores were:
Opacity: 0
Iris: 0
Redness: 0.67
Edema: 0.33
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