2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine

Skin irritation / corrosion

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

Test material information

Constituent 1

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).