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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
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
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
EC Number:
212-706-8
EC Name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
Cas Number:
851-68-3
Molecular formula:
C19H24N2OS
IUPAC Name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
Test material form:
solid: crystalline

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
SKIN DISC PREPARATION
Procedure used: EpiSkin SM kits
Quality control for skin discs: certified ISO 9001

TEMPERATURE USED FOR TEST SYSTEM
Temperature used during treatment/exposure: room temperature
Temperature of post-treatment incubation: 37°C

DYE BINDING METHOD
DYE used in the dye-binding assay: MTT
Spectrophotometer: 96 well plate spectrophotometer
Wavelength: 570 nm
Control samples:
other: Phosphate Buffered Saline (1x PBS); Sodium Dodecyl Sulphate (SDS) 5% aq. solution
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 mikroliter

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 mikroliter
Duration of treatment / exposure:
15 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
32
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
The test chemical is identified as requiring classification and labelling according to UN GHS (category 2 or Category 1), igf the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (<=) to 50% of the negative control.

The test item showed significantly reduced cell viability in comparison to the negative control (mean value: 32%). All obtained test item viability results were below 50% when compared to the viability values obtained from the negative control.

Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The results obtained from this in vitro skin irritation test, using the EPISKIN model, with the test item Racem Tisercin base indicated that the test item is Irritant (UN GHS Category 2) and/or Corrosive (UN GHS Category 1). However, this test method (OECD 439) cannot resolve between UN GHS Categories 1 and 2. However, based on the results of skin corrosion study with Racem Tisercin base (Study Code: 399-431-2184):
The results obtained from this in vitro skin corrosion test, using the EPISKIN model, indicated that the test item reveals no skin corrosion potential under the utilised testing conditions. In conclusion, the test item Racem Tisercin base can be classified as Non-corrosive.

The final classification of the test item Racem Tisercin base is Irritant to skin (UN GHS Category 2).