Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-06-10 - 2016-07-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid
Test material form:
solid: crystalline
Specific details on test material used for the study:
Designation: Art. 808616
Synonym: Taurine
CAS-No.: 107-35-7
Batch: S6261016
Purity: 99.9% (acidimetric)
Appearance: White, crystalline powder
Minimum shelf life: September 30, 2020
Storage: Tightly closed, dry +15 to +25°C

The test item was applied neat to the tissues.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Justification for test system used:
standard model
Vehicle:
unchanged (no vehicle)
Remarks:
No vehicle used; Test item was applied neat to the tissues
Details on test system:
CELL CULTURE
- Supplier: Episkin/SkinEthic Laboratories, Lyon, France
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 16-RHE-066
- Expiration date: 2016-07-04
Control samples:
yes, concurrent negative control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: 16 mg per tissue

NEGATIVE CONTROL
- Amount applied: 16 µL per tissue (Dulbecco`s Phosphate-Buffered Saline)

POSITIVE CONTROL
- Amount applied: 16 µL per tissue
- Concentration: 5% aqueous solution of sodium dodecyl sulfate in deionised water
Duration of treatment / exposure:
42 min (± 1 minute)
Duration of post-treatment incubation (if applicable):
42 hours (± 1 hour)
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Experiment 1 / Run 1
Value:
99.48
Vehicle controls validity:
not applicable
Remarks:
The test item was applied neat to the tissues.
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 2.164, 1.953 and 1.934 and, thus, in the range of ≥0.8 and ≤3.0.

Acceptability of the Positive and Negative Control Data:
After treatment with the negative control (DPBS-buffer) the mean OD was 2.017 (standard deviation: 6.32%) and, thus, higher than the historically established threshold of 1.416.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.12% (standard deviation: 8.14%) and, thus, lower than the historically established threshold of 3.23%.

Variability of the Data:
The standard deviation between the three tissues replicates treated with the test item was 3.11% and, thus, ≤18%. The standard deviations between the three tissue replicates of the negative control and the positive control were 6.32% and 8.14%, respectively, and, thus, ≤18%.

The study met all acceptance criteria.

Any other information on results incl. tables

 Group Time / [min]  Mean OD  Mean Relative viability / [%]
 Negative Control 42  2.017 100 
 Positive Control 42

0.023

1.12

 Test Material

42

1.939

99.48

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
UN GHS: No Category (according to OECD TG 439)
Conclusions:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.