4-dimethylaminobenzaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-04-23 - 2015-06-19

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-dimethylaminobenzaldehyde

EC Number:

202-819-0

EC Name:

4-dimethylaminobenzaldehyde

Cas Number:

100-10-7

Molecular formula:

C9H11NO

IUPAC Name:

4-(dimethylamino)benzaldehyde

Test material form:

solid

Specific details on test material used for the study:

Designation: Art. 803057
Synonym: 4-(Dimethylamino)benzaldehyde
Batch: S6886257
CAS-No.: 100-10-7
Assay (GC, area%): 99.6% (a/a)
Appearance: Grey-blue, crystalline powder
Released until: May 31, 2019
Storage: Tightly closed, dark at room temperature (15 to 25°C)

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from a single donor

Justification for test system used:

standard model

Vehicle:

unchanged (no vehicle)

Remarks:

No vehicle used in this study; The test item was applied neat to the tissues.

Details on test system:

CELL CULTURE
- Supplier: EpiSkin/SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 15-RHE-059
- Expires: May 18, 2015

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

REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.

Control samples:

yes, concurrent negative control

Amount/concentration applied:

TEST MATERIAL: 16 mg of solid test material
NEGATIVE CONTROL: 16 µL (Dulbecco`s Phosphate-Buffered Saline)
POSITIVE CONTROL: 16 µL (5% aqueous solution of sodium dodecyl sulfate in deionised water)

Duration of treatment / exposure:

42 min (± 1 minute)

Duration of post-treatment incubation (if applicable):

42 hours (± 1 hour)

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 1 / Run 1

Value:

95.6

Vehicle controls validity:

not applicable

Remarks:

The test item was applied neat to the tissues

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: none
- Colour interference with MTT: none

ACCEPTANCE OF RESULTS:
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 2.366, 2.297 and 2.516 and, thus, in the range of ≥0.8 and ≤3.0.

Acceptability of the Positive and Negative Control:
After treatment with the negative control (DPBS-buffer) the mean OD was 2.393 (standard deviation: 4.68%) and, thus, higher than the historically established boundary of 1.388.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.02% (standard deviation: 10.96%) and, thus, lower than the historically established boundary of 3.51%.
The standard deviation of the negative control and the positive control was ≤18%, respectively.

Test Substance Data Acceptance Criteria:
The standard deviation of the three tissues treated with the test item was 1.13% and, thus, ≤18%.

Therefore, the study fulfilled the validity criteria.

Any other information on results incl. tables

Group	Time / [min]	Mean OD	Mean Relative viability / [%]
Negative Control	42	2.393	100
Positive Control	42	0.024	1.02
Test Material	42	2.288	95.60

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

UN GHS: No Caterory (according to OECD TG 439)

Conclusions:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this in vitro assay.