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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:
From February 16, 2016 to November 08, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Evercion SR61
- Substance type: Powder
- Composition of test material, percentage of components: 84.05 %
- Lot/batch No.: 4501
- Storage condition of test material: Ambient

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: WEI XIN HANG
- Weight at study initiation: 2.6412-3.4180 kg
- Housing: individually in a stainless steel cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
probability of weak 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: 1 day
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
probability of weak irritation

Any other information on results incl. tables

Table 1. Body weight of the rabbits

Animal ID

Sex

Body weight (kg)

Day 1

Day 4

21

Female

3.4180

3.4394

22

Female

2.8186

2.8698

24

Female

2.6412

2.6926

Table 2. Individual response of the test rabbits

Animal I.D.

Timea (hour)

Observation site

Grades of the irritation reaction

Cornea

Conjunctivae

Iris

Opacity

Area

Redness

Chemosis

Discharge

21

1

Testb

0

0

1

2

0

1

Controlc

0

0

0

0

0

0

24 ± 1

Test

0

0

1

0

0

1

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

22

1

Test

0

0

1

1

0

1

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

1

0

0

1

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24

1

Test

0

0

1

2

0

1

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

1

0

0

1

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

a Observation time was started after application of the test article

b Left eye of the test rabbits

c Right eye of the test rabbits

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, Evercion SR61 cause mildly irritating to the eye. Based on the testing results, Evercion SR61 is not classified under the CLP criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100094001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). Evercion SR61 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. There were no test article effects on body weight. Redness and chemosis of conjunctivae and iris with score of 1 -2 were observed within 24 hours after test article application and fully recovered within 48 hours. On the basis of the test results given above, the response of the test articlecause mildly irritating to the eye. Based on the testing results, Evercion SR61 is not classified under the CLP criteria.