Glucanase, endo-1,3(4)-β-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-04-1996 to 16-08-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of Beta-glucanase, endo-1,3(4) (CAS no, EC no., EC name endo-1,3(4)-beta-glucanase, enzyme class 3.2.1.6)

Molecular formula:

Not applicable

IUPAC Name:

Active enzyme protein of Beta-glucanase, endo-1,3(4) (CAS no, EC no., EC name endo-1,3(4)-beta-glucanase, enzyme class 3.2.1.6)

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:

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 4

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 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:

- Lot/batch No.: PPC 5569
- Expiration date of the lot/batch: December 2006
- Storage condition of test material: Frozen in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Novozymes A/S (previously Novozymes A/S)
- Age at study initiation: 21-23 weeks
- Weight at study initiation: 12.8-3.0 kg
- Housing: The animals were housed individually in plastic cages with mesh floor (Scanbur).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The lower lid of the left eye was gently pulled away from the eye ball and 0.1 mL of the test substance was placed in the conjunctiva! sac. The lids were gently held together for approximately 1 second. The untreated eye served as a control.
- Concentration (if solution): Undiluted test sample.

Duration of treatment / exposure:

The lids were gently held together for approximately 1 second.

Observation period (in vivo):

1, 24, 48, 72 hours.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Few seconds.

SCORING SYSTEM: The ocular irritation scores were classified in accordance with the EEC Directive.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Remarks:

swelling

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

tear flow

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation at any time point.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The instillation of 0.1 mL Pentopan/Biofeed Plus to the conjunctival sac of 3 rabbits caused no signs of eye irritation, and therefore, under the conditions of the EEC Guidelines is not to be classified.

Executive summary:

A test for eye initation in rabbits was performed with Pentopan/Biofeed Plus, batch PPC 5569 in accordance with OECD Guideline No. 405 and adapted to the EEC Directive.

The instillation of 0.1 mL of the test substance to the conjunctival sac of 3 rabbits elicited no reactions on cornea, iris or conjunctiva.

Under the conditions of this test and the criteria of EEC guideline Pentopan/Biofeed Plus, batch PPC 5569, should not be classified.