Registration Dossier
Registration Dossier
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EC number: 211-734-8 | CAS number: 692-86-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Mar to 25 Jun 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no anesthesia, age of animals not stated
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl undec-10-enoate
- EC Number:
- 211-734-8
- EC Name:
- Ethyl undec-10-enoate
- Cas Number:
- 692-86-4
- Molecular formula:
- C13H24O2
- IUPAC Name:
- ethyl undec-10-enoate
- Test material form:
- 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: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: not stated
- Weight at study initiation: 2.9 ±0.1 kg
- Housing: polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet: ad libitum, pelleted commercially available diet, periodically checked (bacteriological and chemical analysis)
- Water: ad libitum, filtered water, periodically checked (bacteriological and chemical analysis)
- Acclimation period:at least 5 days prior to study start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 05 Mar 1997 to 08 Mar 1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
The day before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation. Animals showing signs of ocular irritation, ocular defects or pre-existing corneal injury were not used.
A single dose of 0.1 ml of the test substance was instilled into the conjunctiva! sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as a control. The eyes were not rinsed after administration of the test substance.
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48 and 72 hours after administration of the test substance. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: None
SCORING SYSTEM: Draize scoring system
As no irritant effects were anticipated, the test substance was evaluated in three animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean after
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- None of the animals showed any eye irritation effects. All scores were 0 at all reading time points.
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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