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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 April 2011 - 07 June 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)
Molecular formula:
Not applicable, see remarks.
IUPAC Name:
Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)
Constituent 2
Reference substance name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
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:
other: Fermentation liquid
Details on test material:
Substance type: UVCB
Physical state: fermentation liquid (brown)
Stability under test conditions: the undiluted test material and dilutions in water (50 and 25%) for at least 5 hours at room temperature. The undilutedtest material is stable at least 7 days at 4 degrees Celsius.
Storage conditions of test material: approximately minus 20 degrees Celsius in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two New Zealand White strain rabbits were supplied by Harlan Laboratories U.K. Ltd., Loughborough, UK. At the start of the study the animals weighed 2.67 or 2.84 kg and were twelve to twenty weeks old.
The animals were individually housed in suspended cages with free access to main drinking water and food. The temperature and relative humidity were set to achieve limits of 17 to 23 C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Eyelids were held together for about one second and then released
Observation period (in vivo):
Assessment of ocular damage/irriation was made approx 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
2
Details on study design:
Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: No ocular effects were noted during the study
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular effects were observed in either subject at any time during the study. The substance is not classified as an eye irritant under CLP or GHS criteria based on the results of this study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cellulase should be classified as "Non Irritant".
Executive summary:

The objective of this study was to assess the ocular irritation potential of Cellulase when applied as a single dose (0.1 ml) to the eye of New Zealand rabbits. The study was conducted according to OECD Guideline No. 405 and complied with all GLP standards. A sequential approach was used. In the initial test, the test material was applied at 0.1 ml to the left eye and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours later. The right eye served as control. At the 24-hour reading, fluorescein was instilled and then rinsed with 0.9% NaCl. The eye was then examined with an UV-light to detect corneal damage. A confirmatory test was conducted with 1 rabbit.

No ocular effects were noted during the study. The primary irritation score was 0.0 and Cellulase should be classified as “Non Irritant”.