Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

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:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Cas Number:

68413-24-1

Molecular formula:

C24H36O2

IUPAC Name:

Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): CARDOLITE NC-513
- Physical state: liquid
- Batch no.: GH-0129
- Storage condition of test material: room temperature 20 ± 5 °C, keep away from humidity
- Other: the test item was previously considered as 'Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane' (EC number 500-210-7).

Test animals / tissue source

Species:

other: cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

other: 0.9% sodium chloride solution

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl/per eye
- Concentration (if solution): 20%

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

not applicable

Number of animals or in vitro replicates:

not applicable

Details on study design:

see below

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

0.002

Any other information on results incl. tables

 

IVIS – In Vitro Irritancy Score

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control 0.9 % NaCl	0.420	0.380	14.8%
	0.405
	0.316
Positive Control 10 % NaOH	162.467	149.960	26.0%
	106.209
	181.205
Solvent Control (olive oil )	0.555	0.533	10.4%
	0.574
	0.469
CARDOLITE NC-513	-0.010	0.002	2514.7%
	-0.042
	0.057

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

In an in vitro eye irritation test according to OECD Test Guideline 437 (BCOP), the test item CARDOLITE NC-513 showed no severe eye irritation.

Executive summary:

In an in vitro eye irritation test according to OECD Test Guideline 437 (BCOP), the corneal irritation and damage potential of CARDOLITE NC-513

was investigated by quantitative measurements of changes in opacity and permeability in a bovine cornea.One experiment were performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.

The test item CARDOLITE NC-513 was dissolved in olive oil (10 % solution) and brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

Olive oil was used as negative control. The negative control showed no irritating effect on the cornea.

10% sodium hydroxide solution was used as positive control. The positive control induced a severe irritation on the cornea.

The test item CARDOLITE NC-513 showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.002.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item CARDOLITE NC-513 possesses no eye irritation potential (according to ICCVAM).

According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.