Registration Dossier
Registration Dossier
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EC number: 269-027-5 | CAS number: 68171-38-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun to 08 Aug 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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 in 1987
- Deviations:
- yes
- Remarks:
- no purity reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- Limited documentation, no in vivo testing rationale
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecanoic acid, monoester with propane-1,2-diol
- EC Number:
- 269-027-5
- EC Name:
- Isooctadecanoic acid, monoester with propane-1,2-diol
- Cas Number:
- 68171-38-0
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- 2-hydroxypropyl 15-methylheptadecanoate
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage des Feuilletas
- Age at study initiation: not given
- Weight at study initiation: 2 +/- 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm), grid floor
- Diet: rabbit feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5
- Humidity (%): 55 +/- 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 26 Jun to 03 Jul 1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged product as provided by sponsor
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
Readings at 1h, 24h, 48h, and 72h after instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Chemosis (0-4), Conjunctiva redness (0-3), Iris (0-2), Cornea opacity (0-4)
Eyes were assessed 1, 24, 48 and 72 hours after instillation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
Any other information on results incl. tables
Single instillation, 0.1 mL unchanged test substance, NZW rabbits
Conjunctivae Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
3 |
0 |
0 |
0 |
Iris Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
Chemosis Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
Corneal opacity Draize score
Animal # |
24h |
48h |
72h |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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