Glucanase, endo-1,3(4)-β-

Endpoint summary

Description of key information

Beta-glucanase was tested for skin and eye irritation in rabbits.

- Under the conditions of this test and criterta of the EEC Guidelines Pentopan/Biofeed Plus, batch PPC 5569 should not be classified as an eye irritant.

- 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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-04-1991 to 12-07-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EEC. Acute Toxicity (Skin irritation). Section 84 (L383A/124-L383A/127) of the Annex to the European Communities Directive 92/69/EEC. The Official Journal of the European communities L383A (vol. 35).

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred by Novozymes A/S (previously Novo Nordisk A/S)
- Age at study initiation: 20-21 weeks
- Weight at study initiation: 2.9-3.1 kg
- Housing: The animals were housed individually in plastic cages with mesh floor (Scanbur).
- Diet (e.g. ad libitum): The animals were fed 130 g daily of a standard diet (Altromin 2110, Standard Diet for Rabbits).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 animals

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3'C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): A light cycle of 12 hours light and 12 hours darkness was controlled automatically.

IN-LIFE DATES: From: 1996-04-16 To: 1996-05-22

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as is

Duration of treatment / exposure:

4 hours.

Observation period:

0.5-1, 24, 48, 72 hours after treatment. If skin reactions were observed, further assessments were conducted up to 21 days after test material application to determine the reversibility of the reactions.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: 0.5 mL of test material was applied to the intact skin on each rabbit under 2.5 cm x 2.5 cm patch of gauze. The patch was covered with 3M Micropore Surgical tape 1530-3 to make a semi occlusive bandage. Furthermore an elastic tubular support bandage was applied to prevent the rabbit from damaging the patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The patches were removed gently and the remaining test substance washed off with water.
- Time after start of exposure: Exposure time 4 hours

SCORING SYSTEM:
- Method of calculation:

Erythema and eschar formation
No erythema ...........................................................................................................................0
Very slight erythema (barely perceptible) ..............................................................................1
Well defined erythema ............................................................................................................2
Moderate to severe erythema ................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in depth) ...................4

Oedema formation
No oedema ..............................................................................................................................0
Very slight oedema (barely perceptible) .................................................................................1
Slight oedema (edges of area well defined by definite raising) ..............................................2
Moderate oedema (raised approximately 1 mm) ......................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ..............4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 4-5 days

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All symptoms were fully reversible within 4-5 days after exposure.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test and criterta of the EEC Guidelines Pentopan/Biofeed Plus, batch PPC 5569 should not be classified as a skin irritant.

Executive summary:

A test for skin irritation in rabbits was performed with Pentopan/Biofeed Plus, batch PPC 5569 in accordance with OECD Guideline No. 404 and EEC Directive 1992.

0.5 mL test substance was applied once under a semi occlusive bandage to the shaved back skin of each of 3 rabbits. The length of exposure was 4 hours. The primary skin irritation was evaluated 0.5-1, 24, 48 and 72 hours after removal of the test substance. Irritation was not observed and neither were any clinical reaction to treatment recorded.

Under the test conditions employed, Pentopan/Biofeed Plus was non irritant to rabbit skin and should not be classified as a skin irritant.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

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).

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.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Remarks:

swelling

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Not classified.