Fructofuranosidase, β-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 22 February 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July 1992

Deviations:

yes

Remarks:

occlusive dressing used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal, this coverage

GLP compliance:

yes (incl. QA statement)

Remarks:

Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, Berlin, Germany

Test material

Test material information

1

Reference substance name:

Xylanase, endo-1,4-

EC Number:

232-800-2

EC Name:

Xylanase, endo-1,4-

Cas Number:

9025-57-4

Molecular formula:

Not applicable, see remarks.

IUPAC Name:

endo-1,4-beta-xylanase

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxicology department Rallis Research Centre, Bangalore, India
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 2.16 - 2.31 kg
- Housing: individually in fibre board cages (size: L 77 x B 54 x H 63 cm) with steam sterilized paddy husk bedding
- Diet: Rabbit feed (Nav Maharashtra Chakan Oil Mills Ltd., Maharashtra, India), ad libitum
- Water: Deep bore-well water, ad libitum
- Acclimation period: 7 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 Feb 2002 To: 18 Feb 2002

Test system

Type of coverage:

other: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

NEGATIVE CONTROL
- bare cotton gauze of similar size without any test item applied

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: left side of the dorso-lateral thoracic surface, appriximately 6 cm² (2 x 3 cm)
- Type of wrap if used: adhesive tape, 'Johnson-plast' USP; (Johnson and Johnson Ltd. , Mumbai, India) and a crepe bandage was wrapped around the torso of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: flushed with deionised water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scroing system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No local reactions (erythema, edema) indicative for skin irritation have been observed 1 h after patch removal in any animal.

Other effects:

- Other adverse local effects: There were no skin reactions.
- Other adverse systemic effects: There were no pre-termial deaths, no effects on body weight and no signs of toxicity observed. Also at necropsy no abnormaility was detected.

Any other information on results incl. tables

Table 1: Test for Irritant Effects on the Skin (Expos.: 4 h) Draize grade

animal number	1 h		24 h		48 h		72 h
	erythema	edema	erythema	edema	erythema	edema	erythema	edema
1	1	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

A reliable study conducted in accordance with OECD 404 and GLP, determined the test material to be non-irritating to the skin of rabbits. No edema or erythema were observed at any time point. CLP: not classified