Hydrolyzed Quinoa

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

eperimental start/end date: 16/05/2018 - 18/05/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrolyzed Quinoa

EC Number:

825-815-6

Cas Number:

227025-12-9

IUPAC Name:

Hydrolyzed Quinoa

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Test material form:

liquid

Details on test material:

dark clear liquid

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

40 μl of the test article were applied using nylon mesh on the tissue so as to cover the upper surface

Duration of treatment / exposure:

At the end of the 3 and 60 minutes treatment times, the test articles were removed by rinsing

Duration of post-treatment incubation (if applicable):

180 ± 15 minutes at Standard Culture Conditions (37°C, 5% CO2, 95% RH).

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minutes

Value:

89.7

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minutes

Value:

90.6

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

	3 MINUTES
BLANK	NEGATIVE CONTROL		18E0976 (-2PL)		%NSMTT		%NSCliving		%NSCkilled
0,034	1,576	1,622	1,603	1,318	0,191	0,172	0,037	0,036	0,035	0,036
0,035	1,553	1,580	1,613	1,320	0,193	0,167	0,037	0,037	0,036	0,036
0,035	1,572	1,571	1,625	1,331	0,192	0,171	0,037	0,037	0,036	0,036
0,035	1,565	1,567	1,628	1,313	0,190	0,172	0,037	0,036	0,036	0,036

	60 MINUTES
%NSC	NEGATIVE CONTROL		18E0976 (-2PL)		%NSMTT		%NSCliving		%NSCkilled		POSITIVE CONTROL		%NSMTT (PC)
0,130	1,502	1,467	1,333	1,406	0,165	0,157	0,036	0,035	0,037	0,035	0,071	0,044	0,045	0,043
0,131	1,477	1,476	1,360	1,397	0,166	0,160	0,036	0,036	0,036	0,035	0,073	0,045	0,047	0,043
0,130	1,488	1,466	1,341	1,397	0,166	0,160	0,036	0,036	0,036	0,035	0,073	0,046	0,047	0,043
0,130	1,455	1,479	1,360	1,389	0,166	0,159	0,036	0,036	0,037	0,035	0,073	0,047	0,046	0,045

VIABILITY [%] 3 MINUTES	100,0%	93,1%	3,3%	0,1%	0,1%
VIABILITY [%] 60 MINUTES	100,0%	92,8%	2,2%	0,1%	0,1%	1,0%
TRUE TISSUE VIABILITY	3 MINUTES	89,7%		60 MINUTES	90,6%

This report relates only to the study product provided by the customer and submitted to this study.

According to the classification of the official method and under the conditions of the assay,  the  product:  “Quinoa Pro NPNF (INCI : Hydrolyzed Quinoa) “ is non-corrosive.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Substance is shown to be not corrosive under the conditions of the study.