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Registration Dossier
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EC number: 205-582-1 | CAS number: 143-07-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan 1989 - 1 Mar 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- RCC BNOTOX B.V., 's-Hertogenbosch, The Netherlands
Test material
- Reference substance name:
- Lauric acid
- EC Number:
- 205-582-1
- EC Name:
- Lauric acid
- Cas Number:
- 143-07-7
- Molecular formula:
- C12H24O2
- IUPAC Name:
- dodecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Prifrac 2922
- Analytical purity: not specified
- Physical state: solid
- Storage condition of test material: at room temperature in the dark
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: ca. 14 weeks
- Weight at study initiation: 2670 - 2834 g
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands), ca. 100 g/day
- Water (e.g. ad libitum): tap water diluted with decalcified water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 52.45 +/- 0.45 mg - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
According to Draize (1944)
TOOL USED TO ASSESS SCORE: fluorescein (2% in water; 24 hours after application and on days 4, 8, 15 and 22 in all animals)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 h
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- No corrosion was observed.
- Other effects:
- - Lacrimation was observed in all animals.
- Fluorescein treatment revealed corneal epithelial damage in all animals at all time points.
- No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Readings:
| Time point | Animal | Corneal Opacity | Iris | Conjunctival | Discharge | Additional findings | ||
| Opacity | Area | Erythema | Edema | |||||
| 1 h | 1 | 1 | 4 | 1 | 0 | 3 | 0 | L |
| 2 | 2 | 4 | 1 | 0 | 3 | 0 | L | |
| 3 | 1 | 4 | 1 | 0 | 3 | 0 | L | |
| 24 h | 1 | 1 | 1 | 1 | 3 | 2 | 1 | L |
| 2 | 1 | 4 | 1 | 3 | 2 | 1 | L | |
| 3 | 1 | 1 | 1 | 3 | 1 | 1 | L | |
| 48 h | 1 | 1 | 3 | 0 | 3 | 1 | 2 | L |
| 2 | 1 | 2 | 1 | 3 | 1 | 2 | L | |
| 3 | 0 | 2 | 0 | 3 | 1 | 2 | L | |
| 72 h | 1 | 1 | 4 | 1 | 3 | 2 | 3 | L |
| 2 | 1 | 4 | 1 | 2 | 2 | 3 | L | |
| 3 | 1 | 2 | 1 | 3 | 2 | 3 | L | |
| 7 days | 1 | 2 | 4 | 0 | 3 | 1 | 1 | v |
| 2 | 2 | 4 | 0 | 2 | 1 | 0 | v | |
| 3 | 2 | 1 | 0 | 3 | 1 | 0 | v | |
| 14 days | 1 | 2 | 3 | 0 | 1 | 0 | 1 | v |
| 2 | 2 | 3 | 0 | 1 | 0 | 0 | v | |
| 3 | 2 | 1 | 0 | 2 | 1 | 0 | v | |
| 21 days | 1 | 1 | 4 | 0 | 1 | 0 | 0 | v |
| 2 | 2 | 1 | 0 | 1 | 0 | 0 | v | |
| 3 | 2 | 1 | 0 | 1 | 0 | 0 | v | |
| mean 24 - 48 hours | 1 | 1.0 | 2.7 | 0.7 | 3.0 | 1.7 | 2.0 | |
| 2 | 1.0 | 3.3 | 1.0 | 2.7 | 1.7 | 2.0 | ||
| 3 | 0.7 | 1.7 | 0.7 | 3.0 | 1.3 | 2.0 | ||
| Mean | 0.9 | 0.8 | 2.9 | 1.6 | ||||
L: lacrimation
V: neovascularisation on the cornea
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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