Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 August 2017 to 11 September 2017
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 guidelineopen allclose all
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)
Version / remarks:
2015
Deviations:
no
Qualifier:
according to
Guideline:
other: MatTek Corporation Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; for use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model; 29 June 2015
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
purity >85 % (w/w)

Test animals / tissue source

Species:
human

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes

Results and discussion

In vitro

Results
Irritation parameter:
other: viability
Value:
ca. 85.6 - ca. 93.6
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Results after treatment for 6 hours with Reaction mass of Cucurbit[6]uril, Cucurbit[7]uril and Cucurbit[8]uriland the controls:

Dose Group

Ab-sorbance
Well 1
(Tissue 1/2)

Ab-sorbance
Well 2 (Tissue 1/2)

Mean Absor-bance (Tissue 1/2)

Mean Absorbance* Tissue 1 and 2 minus

Mean Absorbance of
2 Tissues*

Rel. Absorbance [%]
Tissue 1 and 2**

Absolute Value of the Difference of the Rel. Absorbances [%]
Tissue 1 and 2

Mean Rel. Absorbance

[%]***

Blank

0.036

0.036

0.036

0.000

 

 

 

 

Negative Control

1.322

1.411

1.367

1.331

1.366

97.5

5.1

100.0

1.432

1.441

1.436

1.401

102.5

Positive Control

0.411

0.485

0.448

0.412

0.435

30.2

3.3

31.8

0.492

0.494

0.493

0.458

33.5

Test Item

1.171

1.238

1.205

1.169

1.224

85.6

8.0

89.6

1.306

1.322

1.314

1.278

93.6

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was non-irritant in the in vitro eye irritation test in accordance with OECD test guideline no. 492
Executive summary:

This in vitro GLP study was performed to assess the eye irritation potential of the test item "Reaction mass of Cucurbit[6]uril, Cucurbit[7]uril and Cucurbit[8]uril" by means of the Human Cornea Model Test in accordance with OECD test guideline 492. Additional tests with viable or freeze-killed tissues were not performed, since the test item was not coloured intensively, did not dye water or isopropanol, and did not reduce MTT..

About 50 mg of the test item or 50 µL of the controls, respectively, were applied to each of duplicate EpiOculartissue for 6 hours. Treatment with the positive control induced a decrease in the mean relative absorbance compared with the negative control to 31.8%, thus the validity of the test system is ensured. The acceptance criteria were met. The viability of tissue treated with the test item was 89.6 %. Since the viability of tissues treated with the test item did not decrease below 60%, the test item is not considered to possess an eye irritating potential.