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EC number: 292-771-7 | CAS number: 90990-10-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 28 Jan - 01 Mar 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance lauric acid (CAS 143-07-7). In accordance to the ECHA guidance document "Practical guide: How to use alternatives to animal testing" (July 2016), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.e fact that the study was conducted with a read-across substance.
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)
- Version / remarks:
- adopted 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 84/449/EEC, Sep 1984
- Deviations:
- no
- GLP compliance:
- yes
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
- Batch number: 143-07-7
- 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: pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands), ca. 100 g/day
- Water: 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 applied: 52.45 +/- 0.45 mg (equivalent to 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: fluorescein (2% in water adjusted to pH 7.0; 24 and 72 hours after application and on days 7, 14 and 21 in all animals)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Instillation of the test substance affected the cornea, the iris and the conjunctivae. The irritation was still present at termination of the study, but decreased in course of time after installation the test substance.
Lacrimation was observed in all animals.
Fluorescein treatment revealed corneal epithelial damage in all animals 24 and 72 hours and 7, 14 and 21 days after test substance instillation. - Other effects:
- 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 24/48/72 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:
- other: classification as Eye Damage 1, H318 required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
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