Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 18,2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids C10-20, reaction product with diethylenetriamine
EC Number:
940-308-0
IUPAC Name:
Fatty acids C10-20, reaction product with diethylenetriamine
Test material form:
liquid: viscous
Details on test material:
Test substance: Fatty acids, C10-20 neo, recation product with diethylenetriamine
Old name of the test material: MK195KSF
Sample description: orange/brown hazy solid
Storage conditions: at room temperature

Test animals / tissue source

Details on test animals or tissues and environmental conditions:
bovine corneal

Test system

Vehicle:
physiological saline
Remarks:
0.9%
Controls:
not required
Amount / concentration applied:
750uL of test item introduced into the anterior chamber.
Duration of treatment / exposure:
4 hours +/- 5 minutes of incubation
Observation period (in vivo):
none
Number of animals or in vitro replicates:
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with Imidazole 20%

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4h
Score:
78.79

Any other information on results incl. tables

 Opacity: 

Cornea No.

Test Item

Opacity blank value

Opacity post dose

Change of opacity values

Corrected opacity values

1

Negative control

3

4

1

 

2

3

3

0

3

3

3

0

MV

3.00

3.33

0.33

1

Positive control Imidazole

4

173

169

168.67

2

5

207

202

201.67

3

4

175

171

170.67

MV

4.33

185.00

180.67

180.33

1

Test Item

2

29

27

26.67

2

2

54

52

51.67

3

2

65

63

62.67

MV

2.00

49.33

47.33

47.00

Permeability:

Cornea No.

Test Item

OD490

Corrected OD490 values

1

Negative control

-0.003

 

2

0.007

3

-0.011

MV

-0.002

1

Positive control Imidazole

1.930

1.932

2

2.052

2.054

3

2.071

2.073

MV

2.018

2.020

1

Test Item

2.122

2.124

2

2.105

2.107

3

2.123

2.125

MV

2.117

2.119

 

 In vitro score:

Cornea No.

Test Item

Corrected opacity values

Corrected OD490 values

In vitroScore

1

Negative control

1

-0.003

 

2

0

0.007

 

3

0

-0.011

 

MV

0.33

-0.002

0.30

1

Positive control Imidazole

168

1.932

 

2

201.67

2.054

 

3

170.67

2.073

 

MV

180.33

2.020

210.63

1

Test Item

26.67

2.124

 

2

51.67

2.107

 

3

62.67

2.125

 

MV

47.00

2.119

78.79

 

The following mean in vitro score was used to determine:

In vitro score= Mean Opacity Value + (15x Mean OD490 Value) = 47.00 + (15 x 2.19) = 78.79

Therefore the test item was classified as severe irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test item was classified as severe irritant for eyes.