N-(5-chloro-2-isopropylbenzyl)cyclopropanamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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:

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)

Version / remarks:

2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine

EC Number:

941-682-8

Cas Number:

1476113-93-5

Molecular formula:

C13 H18 Cl N

IUPAC Name:

N-{[5-chloro-2-(propan-2-yl)phenyl]methyl}cyclopropanamine

In vitro test system

Test system:

human skin model

Remarks:

EPISKIN-SM

Source species:

human

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent vehicle

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 10 μL

Duration of treatment / exposure:

15 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Test material - mean value of 3 tissues

Value:

17.9

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: irritant or corrosive

Conclusions:

The test substance, the negative or the positive control were exposed to the skin model surface for 15 min after which the tissues were rinsed and incubated for further 42 h. For the test material, the MTT reduction assay revealed a mean relative percentage of viability of the negative control-treated tissues of 17.9%, which was below the threshold for irritation of 50% defined in the OECD 439. Thus, the test substance was shown to have an irritating or corrosive potential towards reconstructed human epidermis tissue in the EPISKIN-SM model. The result does not allow for the classification of the test substance as irritant or corrosive according to EU classification criteria and therefore further evaluation and/or data generation is required.