Registration Dossier
Registration Dossier
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EC number: 204-009-2 | CAS number: 112-84-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Feb - 07 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an established protocol and similar to an appropriate OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (1984)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (Z)-docos-13-enamide
- EC Number:
- 204-009-2
- EC Name:
- (Z)-docos-13-enamide
- Cas Number:
- 112-84-5
- Molecular formula:
- C22H43NO
- IUPAC Name:
- (Z)-docos-13-enamide
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Unislip 1753
- Physical state: solid
- Storage condition of test material: room temperature in the dark
- Analytical purity: 99%
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: 10 weeks
- Housing: Animals were individually housed in plastic cages with a perforated floor
- Diet: 100 g per day (LK-01 and LK-04) standard laboratory animal diet (Hope Farms, Woerden, The Netherlands)
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 50 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and 7 days post-application - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Pocket flash-light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Approximately 1 h post-application two animals showed diffuse conjunctival redness and slight chemosis; the other animal showed slight conjunctival redness and slight chemosis. The conjuctival redness was fully reversible in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Treatment of the eyes with fluorescein 24 hours after exposure revealed no epithelial damage in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Instillation of approximately 60 mg of the test substance in one of the eyes of each of three albino rabbits resulted in slight to diffuse redness of the conjuctivae and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of Kay and Calandra. According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EC (amended by Directive 83/467/EEC), the test substance need not be labelled as an eye irritant.
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