11-methyldodecyl laurate

Eye irritation

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

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. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

11-methyldodecyl laurate

EC Number:

302-853-7

EC Name:

11-methyldodecyl laurate

Cas Number:

94134-83-5

Molecular formula:

C25H50O2

IUPAC Name:

11-methyldodecyl dodecanoate

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

Results

Results 1

Irritation parameter:

other: Final Opacity Value

Run / experiment:

Mean

Value:

0.74

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

other: Final OD490 Value

Run / experiment:

Mean

Value:

-0.009

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

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