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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:
From November 29, 2016 to June 09, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Remarks:
EPISKIN Small Model
Source species:
human
Cell type:
other: reconstructed epidermis of normal human keratinocytes
Cell source:
other: Adult donors
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: % mean cell viability
Value:
100.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Table 1. Optical Density (OD) and the calculated Non Specific Colour % (NSCliving%) of the Additional Control Tissues

Additional control

Optical Density (OD)

NSC %

 

Measured

Blank corrected

Treated with CJ305

1

0.048

0.002

1.0

2

0.059

0.013

mean

0.007

Notes:

1. Mean blank value was 0.046.

2. Optical density means the mean value of the duplicated wells for each sample (rounded to three decimal places).

3. NSC %:Non Specific Colour %

Table 2. Optical Density (OD) and the calculated relative viability % of the samples

Substance

Optical Density (OD)

Viability

(% RV)

SD

 

Measured

Blank corrected

Negative Control:

Phosphate buffered saline

1

0.826

0.780

107.1

6.1

2

0.746

0.699

96.0

3

0.752

0.706

96.9

mean

0.728

100.0

Positive Control:

5% (w/v) SDS solution

1

0.101

0.055

7.5

1.5

2

0.106

0.060

8.2

3

0.085

0.039

5.3

mean

0.051

7.0

Test Item:

CJ305

1

0.766

0.720

98.8

1.6

2

0.789

0.742

101.9

3

0.773

0.726

99.7

mean

0.729

100.2

Notes:

1. Mean blank value was 0.046.

2. Optical density means the mean value of the duplicated wells for each sample (rounded to three decimal places).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 439 test method, CJ305 was non-irritant to skin. CJ305 was not met classification on GHS criteria.
Executive summary:

This test using the procedures outlined in the CiToxLAB Study Plan for 16/377-043B and OECD 439 (OECD, 2015). An in vitro skin irritation test of CJ305 was performed in a reconstructed human epidermis model. EPISKINTM(SM) is designed to predict and classify the irritation potential of chemicals by measuring its cytotoxic effect as reflected in the MTT assay. All data met the validity criteria. The mean cell viability of CJ305 was 100.2% compared to the negative control. This is above the threshold of 50%. Therefore, CJ305 was considered as being non-irritant to skin.