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Administrative data

Description of key information

In Vitro Skin Irritation: Not irritating in the human epidermis model (OECD test guideline no. 439). 
In Vitro Eye Irritation: Not irritating in the human cornea model (OECD test guideline no. 492).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 August 2017 to 20 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2015
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
2009
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
OGYI/38593-5/2012
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
other: test item was wetted with Dulbecco's Phosphate Buffered Saline
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Approximately 25 mg (~ 39 mg/cm2) of the test item were applied to the tissues, wetted with 25 µL DPBS (Dulbecco's Phosphate Buffered Saline) prior to application, and spread to match the surface of the tissue
Duration of treatment / exposure:
60 minutes
Number of replicates:
Three
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
84.4
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No

DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes (treatment with the positive control induced a decrease in the relative absorbance compared with the negative control to 4.2% thus ensuring the validity of the test system)
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: historical values were within the range specified in the test guideline

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

Dose Group

Tissue No.

Absor-bance 570 nm
Well 1

Absor-bance 570 nm
Well 2

Absor-bance 570 nm
Well 3

Mean Absor-bance of 3 Wells

Mean Absor-bance

of three wells blank

corrected

Mean

Absor-bance

of 3 tissues

after blank correction

Rel. Absor-bance [%] Tissue 1, 2 + 3*

Standard Deviation

[%]

Mean Rel. Absorbance (Viability)

[%]

Blank

 

0.039

0.038

0.044

0.040

0.000

 

 

 

 

Negative Control

1

1.396

1.399

1.398

1.398

1.357

1.495

90.8

8.1

100.0

2

1.580

1.593

1.581

1.584

1.544

103.3

3

1.631

1.626

1.612

1.623

1.583

105.9

Positive Control

1

0.103

0.105

0.104

0.104

0.064

0.063

4.3

3.6

4.2

2

0.104

0.105

0.105

0.104

0.064

4.3

3

0.100

0.101

0.100

0.100

0.060

4.0

Test Item

1

1.273

1.302

1.274

1.283

1.243

1.262

83.2

6.2

84.4

2

1.241

1.214

1.249

1.235

1.194

79.9

3

1.406

1.402

1.355

1.388

1.347

90.1

Interpretation of results:
GHS criteria not met
Conclusions:
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 84.4%. The test item therefore was "non-irritant" under the conditions of this in vitro test.
Executive summary:

The purpose of this study was to classify the skin irritation potential of the test item "reaction mass of cucurbit(6]uril, cucurbit[7]uril and cucurbit[8]uril". The study was performed in accordance with OECD test guideline 439 of July 2015 ("In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”). Following exposure to the test item, the mean cell viability was 84.4% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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)
Species:
human
Vehicle:
unchanged (no vehicle)
Controls:
yes
Irritation parameter:
other: viability
Value:
ca. 85.6 - ca. 93.6
Negative controls validity:
valid
Positive controls validity:
valid

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance does not meet the GHS classification criteria for skin and eye irritation.