Registration Dossier

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:
weight of evidence
Study period:
2014-12-01 to 12015-03-23
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:
2015
Report date:
2015

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:
other: Commission Regulation (EU) No. 1152/2010 of 8 December 2010 Part B: Methods for the det.: Bovine Corneal Opacity and Permeability Test, Method for identifying ocular corrosives and severe irritants; Official Journal of the European Union, No. L 324 (B.47?
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-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene
EC Number:
813-130-5
Cas Number:
4039-86-5
Molecular formula:
C10H9ClO
IUPAC Name:
1-chloro-4-[(prop-2-yn-1-yloxy)methyl]benzene

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

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure (test substance)
Value:
0.5
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure (negative control)
Value:
1.9
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure (positive control, ethanol 100 %)
Value:
63.3
Irritation parameter:
in vitro irritation score
Run / experiment:
10 min exposure, 2 h post-exposure (positive control, Dimethylformamid 100 %)
Value:
129

Any other information on results incl. tables

Opacity

Substance

Cornea No.

Initial opacity

Final opacity

Opacity change

Corrected opacity change

Mean

SD

Test substance

10

2.5

5.5

3

1.1

0.5

0.6

11

2.8

5.1

2.3

0.5

12

4.6

5.9

1.3

0.0

Negative control

1

1.7

2.3

0.7

NA

1.8

2.6

2

4.4

3.4

0.0

NA

3

4.3

9.1

4.9

NA

Ethanol (100 %)

4

5.6

36.8

31.2

29.3

32.4

3.5

5

3.7

37.2

33.6

31.7

6

2.1

40.1

38.0

36.2

Dimethylformamid (100 %)

7

2.2

95.9

93.7

91.8

104.0

13.2

8

4.0

123.8

119.8

118.0

9

2.7

106.8

104.1

102.2

 

Permeability

Substance

Cornea No.

Mean OD490

Dilution factor

Mean corrected OD490

Mean

SD

Test substance

10

0.001

1

0.001

0.001

0.001

11

0.002

1

0.002

12

-0.002

1

0

Negative control

1

-0.002

1

NA

0

0

2

0

1

NA

3

0

1

NA

Ethanol (100 %)

4

0.446

5

2.231

2.059

0.318

5

0.338

5

1.691

6

0.451

5

2.253

Dimethylformamid (100 %)

7

0.172

5

0.860

1.665

0.736

8

0.461

5

2.305

9

0.366

5

1.830

 

In Vitro Irritancy score (IVIS)

Substance

Cornea No.

Opacity per cornea

Permeability per cornea

IVIS

per cornea

per group

Mean

SD

Test substance

10

1.1

0.001

1.1

0.5

0.6

11

0.5

0.002

0.5

12

0

0

0

Negative control

1

0.7

0

0.7

1.9

2.6

2

0

0

0

3

4.9

0.001

4.9

Ethanol (100 %)

4

29.3

2.231

62.8

63.3

6.5

5

31.7

1.691

57.1

6

36.2

2.253

70.0

Dimethylformamid (100 %)

7

91.8

0.860

104.7

129.0

23.9

8

118.0

2.305

152.5

9

102.2

1.830

139.7

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating and not corrosive