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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
July 2013
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
EC Number:
813-142-0
Cas Number:
1417782-28-5
Molecular formula:
C15 H10 Cl F3 O2
IUPAC Name:
1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µL

Duration of treatment / exposure:
10 minutes
Duration of post- treatment incubation (in vitro):
2 hours
Number of animals or in vitro replicates:
3
Details on study design:
NUMBER OF REPLICATES: 3 corneas were used per treatment group.

NEGATIVE CONTROL USED: De-ionized water

POSITIVE CONTROL USED: 100% ethanol (PC1) and 100% dimethylformamide (DMF) (PC2)

POST-INCUBATION PERIOD: 2 hours

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Cornea opacity is measured quantitatively as the amount of light transmission through the cornea.
- Corneal permeability: Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea.

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: Evaluation of results were based on the decision criteria used in OECD guideline 437.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
0
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: Not observed

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values:Mean ± SD (Mean-2SD - Mean+2SD)

Historic range of NC
Opacity = 1.8 ± (-1.6 - 5.1)
Permeability = 0.001 ± 0.003 (-0.006 - 0.008)

Historic range PC 1 (100% ethanol)
Opacity = 30.2 ± 5.5 (19.2 - 41.1)
Permeability = 1.761 ± 0.364 (1.032 - 2.490)
IVIS = 56.6 ± 10.1 (36.3 - 76.9)

Historic range PC 1 (100% DMF)
Opacity = 103.6 ± 9.3 (85.1 - 122.2)
Permeability = 1.179 ± 0.627 (-0.074 - 2.432)
IVIS = 121.3 ± 15.2 (90.9 - 151.7)


Any other information on results incl. tables

Table 2: Opacity score of test substance, NC and PC

Test substance

Cornea-No.

Initial opacity

Final opacity

Opacity Change

Corrected Opacity Change*

Mean

SD

Test substance

25

3.2

1.9

-1.3

0.0

0.0

0.0

26

2.1

3.0

0.9

0.0

27

1.8

1.9

0.1

0.0

NC

1

3.7

5.4

1.7

NA

2.0

0.7

2

2.9

5.8

2.8

NA

3

1.5

3.1

1.6

NA

PC 1 (ethanol)

4

4.2

37.8

33.6

31.6

35.1

3.8

5

3.3

40.0

36.7

34.7

6

3.7

44.8

41.2

39.1

PC 2 (DMF)

7

3.4

122.5

119.2

117.1

105.2

10.5

8

0.7

99.9

99.2

97.2

9

2.3

105.6

103.3

101.2

Table 3: Permeability score of the test substance, NC and PC

Test substance

Cornea

No.

Mean

OD490

Dilution

Factor

Mean Corrected OD490*

Mean

SD

Test substance

25

0.003

1

0.000

0.001

0.001

26

0.003

1

0.000

27

0.007

1

0.003

NC

1

0.001

1

NA

0.005

0.004

2

0.005

1

NA

3

0.009

1

NA

PC 1 (ethanol)

4

0.280

5

1.394

1.509

0.415

5

0.395

5

1.969

6

0.234

5

1.164

PC 2 (DMF)

7

0.383

5

1.910

1.321

0.809

8

0.081

5

0.399

9

0.332

5

1.654

Table 4: In Vitro Irritation score (IVIS) of the test substance, NC and PC

 

Cornea No.

Opacity per cornea

Permeability per cornea

IVIS

Per cornea

mean

SD

Test substance

25

0.0

0.000

0.0

0.0

0.0

26

0.0

0.000

0.0

27

0.0

0.003

0.0

NC

1

1.7

0.001

1.7

2.1

0.7

2

2.8

0.005

2.9

3

1.6

0.009

1.7

PC 1 (ethanol)

4

31.6

1.394

52.5

57.8

6.0

5

34.7

1.969

64.2

6

39.1

1.164

56.6

PC 2 (DMF)

7

117.1

1.910

145.8

125.0

21.3

8

97.2

0.399

103.2

9

101.2

1.654

126.0

NA = not applicable; SD = standard deviation, OD490 = optical density at 490 nano meter

*Negative values are set to zero for further calculation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met