Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.