Oxidised Crude Tall Oil

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:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Results 3

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)

Results 4

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Results 5

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.