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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-09-2007 to 13-11-2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted on 24 April 2002.
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Lot/batch No.: PPA26797
- Expiration date of the lot/batch: 12 June 2019
- Storage condition of test material: Frozen in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF bred New Zealand White albino rabbits.
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: Males, young adult
- Weight at study initiation: 1966, 1936 and 2106 g
- Housing: Individually in stainless steel cages with perforated floor.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 0.1 mL.
- Concentration (if solution): Undiluted test sample, 9.5% TOS.
Duration of treatment / exposure:
After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
Observation period (in vivo):
1, 24, 48, 72 hours.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: few seconds

SCORING SYSTEM: The acute irritation of the test sample was classified according to the EC criteria for the labelling and classification of dangerous substances, as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993 and to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003).

Results and discussion

In vivo

Resultsopen allclose all
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:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
swelling
Basis:
mean
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:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
10R Protease, batch PPA26797 was tested for acute eye irritating properties in an experiment with three albino rabbits. At 48 h after treatment, any eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, batch PPA26797 was not irritating to eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, PPA 26797 was also not irritating to eyes.
Executive summary:

10R Protease, batch PPA26797 was tested for acute eye irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.5 and OECD Guideline no. 405.

10R Protease, batch PPA26797 caused slight redness and slight or moderate swelling of the conjunctivae and slight ocular discharge in the three rabbits. At 48 h after treatment, all eye effects had cleared completely.

According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, PPA 26797 was not irritating to (human) eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, batch PPA26797 was also not irritating to (human) eyes.