Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental start/end date: 10/04/2018 - 12/04/2018
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:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
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

Test animals / tissue source

Species:
human
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
yes, concurrent positive control
Amount / concentration applied:
TREATMENT OF LIQUID TEST ARTICLES
1) Pre-Treatment: After the overnight incubation, the tissues were pre-wetted with 20 μL of Ca++Mg++Free DPBS.
The tissues were incubated at standard culture conditions for 30 ± 2 minutes.
2) Test article exposure: After the 30 ± 2 minute Ca++Mg++Free-DPBS pre-treatment, each liquid test and control article was tested by applying 50 μl topically on the EpiOcular™ tissues. The tissues were incubated at standard culture conditions for 30 ± 2 minutes.
Dosing details: 50 μl of the test article were applied directly on the tissue so as to cover the upper surface
3) Rinsing: At the end of the 30 ± 2 minutes treatment time, the test articles were removed by extensively rinsing the tissues with Ca++Mg++-free D-PBS (brought to room temperature). Three clean beakers (glass or plastic with minimal 150 ml capacity), containing a minimum of 100 ml each of Ca++Mg++-free D-PBS were used per test article.
4) Post-Soak: After rinsing, the tissues were immediately transferred to and immersed in 5 ml of previously warmed Assay Medium (room temperature) in a pre-labeled 12-well plate for a 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature. This incubation in Assay Medium was intended to remove any test article absorbed into the tissue.
5) Post-incubation: At the end of the Post-Soak immersion, each insert was removed from the Assay Medium, the medium was decanted off the tissue, and the insert was blotted on absorbent material, and transferred to the appropriate well of the pre-labeled 6-well plate containing 1 ml of warm Assay Medium. The tissues were incubated for 120 ± 15 minutes at standard culture conditions (Post-treatment Incubation).
Duration of treatment / exposure:
30 minutes
Observation period (in vivo):
12 + 120 minutes
Duration of post- treatment incubation (in vitro):
12+120 minutes
Number of animals or in vitro replicates:
6 replicates

Results and discussion

In vitro

Results
Irritation parameter:
other: Percentage of the cell viability (%)
Value:
95.6
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

 

18E0976 (18E0976-1PL) 12.04.2018

BLANK

NEGATIVE CONTROL

POSITIVE CONTROL

18E0447 (-1PL)

%NSMTT

%NSCliving

%NSCkilled

0,036

0,035

2,195

0,542

2,060

0,1512

0,036

0,044

0,036

0,035

2,170

0,548

2,004

0,1513

0,036

0,047

0,036

0,035

2,074

0,470

2,047

0,1342

0,038

0,036

0,036

0,035

2,070

0,462

2,052

0,1392

0,037

0,040

 

 

1,977

0,554

2,184

 

0,038

0,037

1,981

0,554

2,211

0,038

0,037

  

 

VIABILITY [%]

 

100,0%

 

23,8%

 

100,8%

 

5,3%

 

0,1%

 

0,2%

TRUE TISSUE VIABILITY

= [%Viability test] - [%NSMTT]

95,6%

 

 

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) “ isnoirritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
substance is shown to be not irritating under the conditions of the study.