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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
December 14, 2018 - December 15, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 437

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Test System : Isolated cornea from the eyes of freshly slaughtered cattle
Source : Deonar Abattoir slaughter house, Mumbai, Maharashtra
Bovine Age : Between 1 to 5 years (the age of the animals was determined based on the teeth count and horn ring count in addition to the Horizontal Diameter of corneas and central corneal thickness)
Transportation Condition : Transported (in a sealed plastic container) under cold condition in Hanks’ Balanced Salt Solution containing antibiotics [e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL]

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
yes, concurrent positive control
Amount / concentration applied:
750 μL test item (undiluted)
Duration of treatment / exposure:
Corneas were exposed for approximately 10 minutes ± 30 seconds at 32 ± 1 °C
Duration of post- treatment incubation (in vitro):
2 hours ± 10 minutes at 32 ± 1ºC
Number of animals or in vitro replicates:
three replicate for each condition (Normal saline, N,N-Dimethylformamide, 11-methyldodecyl laurate)

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: Final Opacity Value
Run / experiment:
Mean
Value:
0.74
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Final OD490 Value
Run / experiment:
Mean
Value:
-0.009
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: IVIS
Run / experiment:
Mean
Value:
0.61
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Normal Saline (0.75 mL)

Cornea Holder N°

Io

 (LUX)

I (Initial)

(LUX)

Initial Opacity Value

I

(Post Treatment)

(LUX)

Post Treatment Opacity

Value

Corr. Opacity

Value

OD490

Value

Corr. OD490

Value

IVIS

18

1090

1025

2.95

1021

3.11

0.16

0.077

0.038

0.73

20

1116

1033

3.62

1038

3.42

-0.20

0.084

0.045

0.48

26

1073

1015

2.70

1013

2.78

0.08

0.079

0.04

0.68

Mean

0.01

-

0.041

0.63

SD

0.19

-

0.004

0.13

 

N,N-Dimethylformamide (0.75 mL)

Cornea holder N°

Io

(LUX)

I (Initial)

(LUX)

Initial Opacity Value

I

(Post

Treatment)

(LUX)

Post Treatment Opacity

Value

Corr. Opacity

Value

Final Opacity

Value

OD490

Value

Corr. OD490

Value

Final OD490

Value

IVIS

19

1117

1075

1.98

305

106.49

104.51

104.50

1.293

1.254

1.213

122.70

23

1142

1063

3.38

297

113.77

110.39

110.38

1.526

1.487

1.446

132.07

27

1137

1085

2.33

327

99.11

96.78

96.77

1.871

1.832

1.791

123.64

Mean

103.88

-

1.524

1.483

126.14

SD

6.83

-

0.291

0.291

5.16

 

11-Methyldodecyl Laurate(0.75 mL)

Cornea holder N°

Io

 (LUX)

I (Initial)

(LUX)

Initial Opacity Value

I

(Post

Treatment)

(LUX)

Post Treatment Opacity Value

Corr. Opacity Value

Final Opacity Value

OD490

Value

Corr. OD490Value

Final OD490

Value

IVIS

21

1099

1039

2.72

1030

3.09

0.37

0.36

0.073

0.034

-0.007

0.26

25

1245

1159

3.38

1128

4.55

1.17

1.16

0.063

0.024

-0.017

0.91

28

1107

1054

2.43

1036

3.15

0.72

0.71

0.076

0.037

-0.004

0.65

Mean

0.74

-

0.032

-0.009

0.61

SD

0.40

-

0.007

0.007

0.33

Keys: IVIS = In Vitro Irritation Score, Io =Baseline Reading (With medium but without cornea), I = LUX Reading with Medium and Cornea, OD490= Optical Density at 490 Wave Length, - = Not Applicable,
Corr. = Corrected. Blank OD490value = 0.039.


 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean IVIS score for the corneas, treated with 11-methyldodecyl laurate, was found to be 0.61.
Based on results from this study, the classification for 11-methyldodecyl laurate is as follows:
Classification (OECD 437 UN GHS): No Category
Executive summary:

This study was conducted to evaluate theocular irritancy of11-methyldodecyl laurate,in compliance with the OECD test guideline437 for theBCOP test.

Three sets, each consisting of three corneas were tested. The first set was treated with750 μLof normal saline (control), the second set was treated with750 μL ofdimethylformamide (positive control), and thethird set wastreated with750 μLof the test item,11-methyldodecyl laurate.Post application, corneas were incubated for approximately 10 minutes,after which the test item was washed-off. Corneas were then incubated for approximately 2 hat32 ± 1 ºC. At theend of incubation opacity readings were taken.

The post opacity permeability reading was measured by applying1 mL of fluorescein sodium solution
(4 mg/mL)
on to the anterior surface of the cornea followed by incubation for approximately90 min at
32 ºC. At the end of incubation, the Optical Density (OD) was measured at 490 nm, from fluid collected from the posterior chamber.

The mean in-vitroIrritancy Score(IVIS) ofnormal saline (control)anddimethylformamide(positive control)treated corneaswere found to be 0.63 and 126.14 which confirmed the reliability of the test procedure. The IVIS score for corneas, treated with11-methyldodecyl laurate was found to be 0.61.Based on results of this study, the classification for11-methyldodecyl laurateis as follows:

Classification (OECD 437UN GHS)   :          No Category