Fructofuranosidase, β-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 - 24 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:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 February 1987

Deviations:

no

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Toxicology department Rallis Research Centre, Bangalore, India
- Age at study initiation: 5 - 6 months
- Weight at study initiation: 2.09 - 2.29 g
- 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: 24 Feb 2002

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: eyes were irrigated with deionised water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

INTERPRETATION OF RESULTS: Modified version of the Kay and Calandra System. The numeric values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae was designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+ B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C. 1962., (J. Soc. Cosmet. Chem., 13:281 -289) was used to classify the ocular irritancy potential of the test item. This is achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation was calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled the classification of the eye irritancy potential of the test item.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Additional time point 1h (for further details please refer to table 1 in the "Any other information on results incl. tables):
Cornea opacity: mean / of 3 animals was 0.
Iris score: mean / of 3 animals was 0.
Conjuctivae score: mean / of 3 animals 0.
Chemosis score: mean / of 3 animals 0.

Other effects:

- Ophthalmoscopic findings: No eye reactions, indicating irritation, were observed.
- Other observations: No deaths were observed and the body weights of all rabbits increased during the observation period. There were no signs of toxicity observed and necropsy did not reveal any abnormalities.

Any other information on results incl. tables

Table 1: Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0
2	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0
3	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	0.00	0.00	0.00	0.00
	24	0.00	0.00	0.00	0.00
	48	0.00	0.00	0.00	0.00
	72	0.00	0.00	0.00	0.00
	24+48+72	0.00	0.00	0.00	0.00

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:

Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties towards the eyes. CLP: not classified