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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

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

Species:

other: not applicable (Human reconstitued skin)

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

Commercially available Epi-200-SIT-Kit was used.
The EpiDermTM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.

Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Day of delivery: 11. Dec. 2012; batch: 16865.

Test system

Type of coverage:

open

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl/well

Duration of treatment / exposure:

35 - 60 min

Observation period:

not applicable

Number of animals:

three tisue were used

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: cell viability

Value:

90

Remarks on result:

other: Cell viability 90% (above threshold)

Any other information on results incl. tables

% Formazan Production

Designation	CARDOLITE NC-513	Positive Control
% Formazan production (Tissue 1)	92.3%	6.7%
% Formazan production (Tissue 2)	88.8%	6.8%
% Formazan production (Tissue 3)	89.1%	7.2%
% Formazan production Mean	90.0%	6.9%

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating according to EU GHS criteria

Conclusions:

In a GLP-study according to OECD Test Guideline 439, the registered substance was not skin irritating.

Executive summary:

The Skin Irritation Potential of CARDOLITE NC-513 was determined in the Human Skin Model Test following EU-Method B.46 resp. OECD 439.

One valid experiment was performed. Three tissues of the human skin model EpiDerm^TMwere treated withCARDOLITE NC-513for 60 minutes. 30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm²; as indicated by supplier). DPBS-buffer was used as negative control, 5 % SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18 %).

After the treatment with the test item, the relative absorbance values were reduced to 90.0 %. This value is well above the threshold for irritation potential (50 %). Therefore, CARDOLITE NC-513 is considered as not irritant in the Human Skin Model Test.