Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
None

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: Reconstituted human epidermis
Source strain:
not specified
Vehicle:
other: Dulbecco’s phosphate buffered saline (DPBS)
Details on test system:
EPISKIN Kit
Duration of treatment / exposure:
15 minutes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
68.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: Assessment of Irritation Potential was based on the % Formazan production. Assessment was as follows: ≤ 50% of negative control- Irritant. > 50% of negative control - Non-irritant. Reversibility: other:. Remarks: The % viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be non-irritant to skin.

In vivo

Other effects:
The negative controls mean OD was found to be 1.377, which is well within the acceptability range. The % viability of the positive control was 17.8% and it was lesser than 50% of the negative control, which reflects the irritant nature of positive control and the sensitivity of the tissues used in the study.

Any other information on results incl. tables

RESULTS

BLANK CORRECTED OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE

Blank Corrected ODs

Replicate

NC

PC

Test item

Rep 1

NCR1a

PCR1a

4819R1a

1.351

0.294

0.985

NCR1b

PCR1b

4819R1b

1.290

0.226

0.842

Rep 2

NCR2a

PCR2a

4819R2a

1.505

0.232

0.946

NCR2b

PCR2b

4819R2b

1.439

0.257

1.112

Rep 3

NCR3a

PCR3a

4819R3a

1.336

0.242

0.848

NCR3b

PCR3b

4819R3b

1.341

0.226

0.898

                       Mean OD of blank: 0.070

MEAN OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE 

Mean ODs

Replicate

NC

PC

Test item

Rep 1

1.320

0.260

0.913

Rep 2

1.472

0.244

1.029

Rep 3

1.338

0.234

0.873

Mean

1.377

0.246

0.938

SD

0.083

0.013

0.081

%RSD

6.01

5.32

8.63

 

Key: Rep/R: Replicate; NC: Negative control; PC: Positive control; SD: Standard deviation; %RSD: Percent relative standard deviation; 4819= study number for test item FAT 40865/A TE

PERCENT VIABILITY (%)

% Viability

Replicate

PC

Test item

Rep 1

18.852

66.328

Rep 2

17.726

74.718

Rep 3

16.963

63.385

Mean

17.847

68.144

SD

0.950

5.881

% RSD

5.32

8.63

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be a non-irritant to skin.
Executive summary:

An in vitro study was performed in accordance to OECD Guideline 439 in compilance with GLP to assess the skin irritation potential of test item FAT 40865/A . The percent viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be a non-irritant to skin in accordance with UN GHS.