2-bromo-4-chloro-1-isopropylbenzene

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:

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:

2013

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-bromo-4-chloro-1-(propan-2-yl)benzene

EC Number:

696-543-1

Cas Number:

1369828-32-9

Molecular formula:

C9H10BrCl

IUPAC Name:

2-bromo-4-chloro-1-(propan-2-yl)benzene

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 10 μL
- Concentration: neat/ undiluted

NEGATIVE CONTROL
- Amount(s) applied: 50 μL

POSITIVE CONTROL
- Amount(s) applied: 50 μL

Duration of treatment / exposure:

15 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

triplicate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

test material group (mean of 3 replicates)

Value:

63.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: As the test material interfered with MTT, an appropriate correction (subtracting the Non-Specific MTT Reduction value) was applied for test material treated samples.

Applicant's summary and conclusion

Interpretation of results:

other: not irritant

Conclusions:

In this in vitro skin irritation study using the reconstructed human epidermis model EPISKIN-SM, 10 µL of test substance were applied to the tissues for 15 min, followed by removal of the test material and a post treatment incubation of 42 h. Afterwards, an MTT assay was performed to measure the cell viability, which resulted for the test material in a value of 63.3% compared to the negative control, indicating that the test material is not irritant and thus needs no classification according to EU classification criteria.