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EC number: 938-639-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03-11-2014 - 13-11-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed to meet the requirements of the Chinese legislation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oxidised Crude Tall Oil
- EC Number:
- 938-639-0
- Molecular formula:
- C17-20H29-35CO2H. O6-10
- IUPAC Name:
- Oxidised Crude Tall Oil
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): EnvaMul™200
- Substance type: UVCB
- Physical state: Dark brown, opaque, viscous liquid
- Analytical purity: UVCB 100%
- Lot/batch No.: 042313
- Stability under test conditions: stable
- Storage condition of test material: oom temperature, protected from light
- Expiry date: 23 -Apr-2015
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, IN or Denver, PA
- Age at study initiation: 12 to 17 months
- Weight at study initiation: 4109.7 to 4337.8 g
- Housing: individually in stainless steel cages elevated aboveground corncob bedding
- Diet: 150 g PMI Nutrition International, LLC, Certified Rabbit HF LabDiet® 5325 + one kale leaf 3 times weakly
- Water: municipal water ad libitum
- Acclimation period: 0 - 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.4°C to 18.9°C
- Humidity (%): 32.5% to 39.6%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
VEHICLE : NA - Duration of treatment / exposure:
- NA ( no eye wash performed)
- Observation period (in vivo):
- 3 to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: macropscopic examination and fluorescein for all cornea observations
TOPICAL ANESTHETICS AND SYSTEMIC ANALGESICS: according to the guideline
60 min before application: buneprophine (0.01 mg/ kg bw s.c.)
5 min before application: 0.5% proparacaine hydrochloride in each eye
8 hours after application: buneprophine (0.01 mg/ kg bw s.c.) and meloxicam (0.5 mg/kg s.c.)
thereafter: buneprophine (0.01 mg/ kg bw s.c.) every 12 hours, combined with meloxicam (0.5 mg/kg s.c.) every 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h (2 animals), 7 days (1 animal)
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
|||||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
4 |
7 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
1 |
1 |
0 |
2 |
2 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
discharge |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eye
- Executive summary:
Three rabbits received 0.1 mL test substance in their eye after receiving topical anesthetics and systemic analgesics. No signs of irritation were observed during the 3 to 7 days test period. Slight redness was fully reversed at the end of the observation period. Therefore it is concluded that the substance is not irritating to the eye.
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