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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-10-15 to 2015-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental study according to guideline and GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
2013
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Version / remarks:
2010
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(vinyloxy)dodecane
EC Number:
212-141-7
EC Name:
1-(vinyloxy)dodecane
Cas Number:
765-14-0
Molecular formula:
C14H28O
IUPAC Name:
1-(ethenyloxy)dodecane

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µL
- Concentration: undiluted
Duration of treatment / exposure:
10 min
Details on study design:
Please refer to "Any other information on materials and methods".

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure
Value:
ca. 0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Opacity

Substance

Cornea No.

Initial opacity

Final opacity

Opacity change

Corrected opacity change

Mean

SD

Test substance

19

4.6

6.1

1.5

0.0

0.0

0.0

20

5.4

9.5

4.1

0.0

21

3.9

4.3

0.4

0.0

Negative control

1

3.1

6.6

3.5

NA

4.1

2.3

2

3.4

10.1

6.7

NA

3

3.4

5.6

2.2

NA

Ethanol (100 %)

4

6.2

35.8

29.6

25.4

25.0

3.2

5

6.1

38.3

32.2

28.1

6

6.2

31.9

25.8

21.6

Dimethylformamid (100 %)

7

3.5

100.1

96.7

95.5

99.4

6.4

8

3.5

112.7

109.3

105.1

9

3.6

108.3

104.7

100.5

 

Permeability

Substance

Cornea No.

Mean OD490

Dilution factor

Mean corrected OD490

Mean

SD

Test substance

19

-0.001

1

0.000

0

0

20

0.000

1

0.000

21

-0.003

1

0.000

Negative control

1

-0.003

1

NA

0

0

2

-0.002

1

NA

3

-0.002

1

NA

Ethanol (100 %)

4

1.162

1

1.162

0.917

0.261

5

0.947

1

0.947

6

0.643

1

0.643

Dimethylformamid (100 %)

7

0.513

1

0.513

0.782

0.245

8

0.992

1

0.992

9

0.842

1

0.842

 

In Vitro Irritancy score (IVIS)

Substance

Cornea No.

Opacity per cornea

Permeability per cornea

IVIS

per cornea

per group

Mean

SD

Test substance

19

0.0

0.000

0.0

0.0

0.0

20

0.0

0.000

0.0

21

0.0

0.000

0.0

Negative control

1

3.5

0.000

3.5

4.1

2.3

2

6.7

0.000

6.7

3

2.2

0.000

2.2

Ethanol (100 %)

4

25.4

1.162

42.9

38.8

6.5

5

28.1

0.947

42.3

6

21.6

0.643

31.3

Dimethylformamid (100 %)

7

92.5

0.513

100.2

111.1

10.1

8

105.1

0.992

120.0

9

100.5

0.842

113.2

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information