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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 05, 2016 to October 11, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]-, subsequently coupled with Urea, N-(3-aminophenyl)-, subsequently condensation with 1,3,5-Triazine, 2,4,6-trichloro-, further condensation with Benzenesulfonic acid, 3-amino- and 3-Pyridinecarboxylic acid, sodium salts
EC Number:
944-617-1
Molecular formula:
C8H11NO9S3 . C7H9N3O . C3Cl3N3 . C6H7NO3S . C6H5NO2 . Na
IUPAC Name:
Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]-, subsequently coupled with Urea, N-(3-aminophenyl)-, subsequently condensation with 1,3,5-Triazine, 2,4,6-trichloro-, further condensation with Benzenesulfonic acid, 3-amino- and 3-Pyridinecarboxylic acid, sodium salts
Test material form:
solid: particulate/powder

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: 2.8030-3.3330 kg
- Housing: individually in a stainless steel wire mesh 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:
animal: #01, #04 and #10
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #01, #04 and #10
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: #01, #04 and #10
Time point:
24/48/72 h
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #01, #04 and #10
Time point:
24/48/72 h
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of 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

01

Female

2.8030

2.8488

04

Female

3.3330

3.3809

10

Female

2.8038

2.8538

 

Table 2. Individual response of the test rabbits

Animal I.D.

Timea (hour)

 

Grades of the irritation reaction

Cornea

Conjunctivae

Iris

Opacity

Area

Redness

Chemosis

Discharge

01

1

Testb

0

0

1

0

2

0

Controlc

0

0

0

0

0

0

24 ± 1

Test

0

0

1

1

0

0

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

04

1

Test

0

0

1

1

2

0

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

0

0

0

0

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

10

1

Test

0

0

1

1

2

0

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

0

0

0

0

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, CR SB07 showed that non-irritant to the eye. Therefore, CR SB07 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100062001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). CR SB07 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. Reversible conjunctivalredness, chemosisanddischargewas observed within 48 hours after test article application.On the basis of the test results given above, the response of the test article was non-irritant to the eye.