acetylxylan esterase

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)

Molecular formula:

Not applicable, see remarks

IUPAC Name:

Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)

Constituent 2

Reference substance name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available

IUPAC Name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Constituent 3

Reference substance name:

Carbohydrates constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Carbohydrates constituent of enzyme deriving from the fermentation or extraction process

Constituent 4

Reference substance name:

Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process

Constituent 5

Reference substance name:

Lipids as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Lipids as a constituent of enzyme deriving from the fermentation or extraction process

Test material form:

liquid

Details on test material:

Substance type: UVCB
Physical state: translucent tan liquid

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., Denver, PA
- Age at study initiation: 125 days old
- Weight at study initiation: 2.8 kg
- Housing: The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet #5321) provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled but details were not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each rabbit was dosed. The contralateral eye served as a control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

Observations were made at 1, 24, 48, and 72 hours after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: Eyes were not washed after dosing

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Using a Mini-Mag lite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Sodium fluorescein dye procedures were used at the 24-hour observation interval.

Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no corneal opacity or iritis noted at any observation period. Conjunctiva! irritation, noted in 1/3 eyes, cleared by 24 hours.

Other effects:

There were no abnormal physical signs noted during the observation period. Body weights were normal.

Any other information on results incl. tables

Table 1 - Ocular Findings and Systemic Observations

 

Animal #	Item	Tissue	Reading	At 1 hour	At 24 hours	At 48 hours	At 72 hours
1	A B	Cornea	Opacity Area	0 0	0 0	0 0	0 0
	C	Iris		0	0	0	0
	D E F	Conjunctiva	Redness Chemosis Discharge	0 0 0	0 0 0	0 0 0	0 0 0
	Systemic observations			Normal	Normal	Normal	Normal
	Sodium Fluorescein			Not done	0	Not done	Not done

 

Animal #	Item	Tissue	Reading	At 1 hour	At 24 hours	At 48 hours	At 72 hours
2	A B	Cornea	Opacity Area	0 0	0 0	0 0	0 0
	C	Iris		0	0	0	0
	D E F	Conjunctiva	Redness Chemosis Discharge	0 0 0	0 0 0	0 0 0	0 0 0
	Systemic observations			Normal	Normal	Normal	Normal
	Sodium Fluorescein			Not done	0	Not done	Not done

 

Animal #	Item	Tissue	Reading	At 1 hour	At 24 hours	At 48 hours	At 72 hours
3	A B	Cornea	Opacity Area	0 0	0 0	0 0	0 0
	C	Iris		0	0	0	0
	D E F	Conjunctiva	Redness Chemosis Discharge	0 0 1	0 0 0	0 0 0	0 0 0
	Systemic observations			Normal	Normal	Normal	Normal
	Sodium Fluorescein			Not done	0	Not done	Not done

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Irritation obseerved in 1/3 rabbits cleared by 24 hours. No corneal opacity or iritis was noted at any observation period.

Executive summary:

To determine the irritant or corrosive effects, if any, of a test article when instilled into the rabbit eye in accordance with OECD Test Guideline 405. One eye of each rabbit was dosed. The contralateral eye served as a control. The test article (0.1 mL) was placed by syringe into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article. Using a Mini-Mag lite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours post-dose. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.

There was no corneal opacity or iritis noted at any observation period. Conjunctiva! irritation, noted in 1/3 eyes, cleared by 24 hours. There were no abnormal physical signs noted during the observation period. Body weights were normal.