Amides, C16-18, N-[3-(dimethylamino)propyl]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2012-09-04 to 2012-09-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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)

Version / remarks:

24 August 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 22 July 2010

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)

IUPAC Name:

7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)

Details on test material:

- Chemical name: Stearic acid 3-(dimethylaminopropyl)amide

Test animals

Species:

other: EPISKIN model

Test system

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable, in vitro test

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.6 to 14.5 mg
- The skin was moistened with 5 μl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test substance to the tissue and the solid test substance

VEHICLE
- no

Duration of treatment / exposure:

15

Observation period:

42 h

Number of animals:

not applicable, in vitro test

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: tissue viability

Value:

108

Remarks on result:

other:

Remarks:

Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: test substance. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: tissue viability

Value:

100

Remarks on result:

other:

Remarks:

Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: negative control (PBS). (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: tissue viability

Value:

5

Remarks on result:

other:

Remarks:

Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: postitive control (5% SDS). (migrated information)

In vivo

Irritant / corrosive response data:

The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 108%. Since the mean relative tissue viability was above 50%, the test substance is considered to be non-irritant. The positive control had a mean cell viability of 5% after 15 minutes exposure.

Any other information on results incl. tables

Mean absorption in thein vitroskin irritation test with the test substance

	A (OD 570)	B (OD 570)	C (OD 570)	Mean (OD 570)		SD
Negative control	1.122	1.012	1.083	1.073	±	0.056
test substance	1.153	1.112	1.195	1.153	±	0.042
Positive control	0.056	0.051	0.059	0.056	±	0.004

OD = opticaldensity

SD = Standard deviation

Triplicate exposures are indicated by A, B and C.

In this table the values are corrected for background absorption (0.000). Isopropanol was used to measure the background absorption.

 

Mean tissue viability in the in vitro skin irritation test with the test substance

	mean tissue viability (% of control)
Negative control	100
test substance	108
Positive control	5

 

INDIVIDUAL OD MEASUREMENTS AT 570 NM

 

A	A (OD570)	B (OD570)	C (OD570)
Negative control OD570measurement 1 OD570measurement 2	1.034 1.211	0.995 1.030	1.094 1.073
test substance on viable tissue OD570measurement 1 OD570measurement 2	1.177 1.130	1.191 1.033	1.199 1.191
test substance on killed tissue OD570measurement 1 OD570measurement 2	0.055 0.111	0.031 0.045	0.042 0.065
Non treated killed tissue OD570measurement 1 OD570measurement 2	0.068 0.085	0.073 0.050	0.039 0.037
Positive control OD570measurement 1 OD570measurement 2	0.055 0.057	0.050 0.053	0.059 0.060

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In this in vitro skin irritation test Stearic acid 3-(dimethylaminopropyl)amide was not irritating.

Executive summary:

In an in vitro dermal irritation study according to OECD guideline 439, adopted 22 July 2010 and EU method B.46, August 2009, Stearic acid 3-(dimethylaminopropyl)amide was applied to in triplicate to EPISKIN tissues for 15 min. PBS was used as negative control, 5% SDS as positive control. After exposure the skin tissues were thoroughly rinsed to remove the test substance and transferred to fresh medium. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed.

The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 108%. Since the mean relative tissue viability was above 50%, the test substance is considered to be non-irritant. The positive control had a mean cell viability of 5% after 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.

In this in vitro skin irritation test Stearic acid 3-(dimethylaminopropyl)amide was not irritating.