N-[3-(dimethylamino)propyl]stearamide monoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From : 2014-10-28 To: 2014-12-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]stearamide monoacetate

EC Number:

236-291-8

EC Name:

N-[3-(dimethylamino)propyl]stearamide monoacetate

Cas Number:

13282-70-7

Molecular formula:

C23H48N2O.C2H4O2

IUPAC Name:

N-[3-(dimethylamino)propyl]stearamide monoacetate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc. Mocksville, NC on November 5 and November 12, 2014.
- Age at study initiation: Young adult (10 weeks)
- Weight at study initiation: 2383-2702 grams at experimental start.
- Housing:stainless steel caging.
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period:6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-50%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.

IN-LIFE DATES: From: To:

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 30-60 minutes and 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3501

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3501

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal: 3502

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal: 3502

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal: 3503

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal: 3503

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There was no skin irritation observed at any treated site during this study.

Any other information on results incl. tables

Individual Skin Irritation Scores

Erythema/Edema 

			Time After Patch Removal
Animal n.	Sex	Immediately after patch removal	30-60 min	24 hrs	48 hrs	72 hrs
3501	F	0/0	0/0	0/0	0/0	0/0
3502	F	n/a	0/0	0/0	0/0	0/0
3503	F	n/a	0/0	0/0	0/0	0/0

N/A – Not Applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required.

Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation after a single topical application.

At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al.1 (see Table 4) immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

There was no skin irritation observed at any treated site during this study.

In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required based on the results of this study.

According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required.