Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(7-methoxynaphthalen-1-yl)ethan-1-amine hydrochloride
EC Number:
604-144-0
Cas Number:
139525-77-2
Molecular formula:
C13H15NO.HCl
IUPAC Name:
2-(7-methoxynaphthalen-1-yl)ethan-1-amine hydrochloride
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch : 18113833Purity : 100,7%Expiry date : 1 septembre 2018Storage conditions : room temperature in the dark

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
negative control : 50 µLpositive control : 50 µLTest item : 25 mg
Duration of treatment / exposure:
3 mn and 60 mn
Duration of post-treatment incubation (if applicable):
60 mn
Number of replicates:
2 per dose/ control

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 mn
Value:
ca. 70.7
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 mn
Value:
ca. 13.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The mean OD562 for the negative control treated tissues was 1.720 for the 3-Minute exposure period and 1.541 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.The relative mean tissue viability for the positive control treated tissues was 6.1% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The test item was considered to be corrosive to the skin.EU CLP Regulation (EC) No 1272/2008 and UN GHS Hazard statement H314 “Causes severe skin burns and eye damage” Category 1B or 1C.UN Packing Group II or III “Substance Presenting Minor or Medium Danger”.
Executive summary:

The Mephtamin-HCL, on the basis of EPIDERM Skin Corrosion Test, is considered to be corrosive to the skin (Category 1)