Ginger, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

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)

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Ginger, ext.

EC Number:

283-634-2

EC Name:

Ginger, ext.

Cas Number:

84696-15-1

Molecular formula:

N/A

IUPAC Name:

Essential oil extract of Zingiber officinalis (Zingiberaceae) root GINGER ESSENTIAL OIL Ginger Oil Ginger Oleoresin Ginger, ext Ginger, ext. Ginger, Extrakt HE Zingiber officinalis INCI name: Zingiber Officinale (Ginger) Root Extract OILS, GINGER Reaction mass of camphene and pin-2(3)-ene and 7-methyl-3-methyleneocta-1,6-diene and pin-2(10)-ene and cineole and [S-(R*,S*)]-5-(1,5-dimethylhexen-4-yl)-2-methyl-1,3-cyclohexa-1,3-diene and (R)-p-mentha-1,8-diene Zingiber officinalis, Zingiberaceae.

Test animals / tissue source

Species:

other: Bovine corneas

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Bovine corneas were used. They were collected from slaughtered cattle which were be-tween 12 and 60 months old.

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Value:

0.061

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Optical density at 492 nm of Negative Control, Test Item and Positive Control

Parameter	Negative Control				Test Item			Positive Control
1. Measurement	0.076	0.054	0.059		0.050	0.127	0.190	0.851	0.751	0.739
2. Measurement	0.075	0.053	0.056		0.050	0.127	0.188	0.840	0.743	0.738
3. Measurement	0.080	0.053	0.052		0.051	0.131	0.189	0.852	0.752	0.744
1. Measurement – blank	0.0417	0.0197	0.0247	0.0157		0.0927	0.1557	0.8167	0.7167	0.7047
2. Measurement – blank	0.0407	0.0187	0.0217	0.0157		0.0927	0.1537	0.8057	0.7087	0.7037
3. Measurement – blank	0.0457	0.0187	0.0177	0.0167		0.0967	0.1547	0.8177	0.7177	0.7097
Mean of each replicate	0.0427	0.0190	0.0213	0.0160		0.0940	0.1547	0.8133	0.7143	0.7060
Mean of the 3 replicates	0.0277			--				--
Corrected	--	--	--	-0.0117		0.0663	0.1270	0.7857	0.6867	0.6783
Corrected mean of the 3 replicates	--			0.0606				0.7169

IVIS The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control HBSS	1.37	0.92	43.55%
	0.75
	0.62
Test Item Ginger, ext.	0.75	0.98	95.75%
	0.18
	2.02
Positive Control DMF undiluted	66.90	68.75	2.39%
	70.05
	69.30

Applicant's summary and conclusion

Conclusions:

no classification for eye irritation or serious eye damage.