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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes
Value:
89.7
Negative controls validity:
valid
Positive controls validity:
valid
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.