N,N-dimethyloctadecylamine N-oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Draize method

Principles of method if other than guideline:

Four skin lotions, containing 2.5% C18 Amine Oxide (CAS No. 2571-88-2), were tested for skin irritation in rabbits according to the Draize method. The objective is to compare the skin irritation score between skin lotion containing mineral oil or isopropyl palmitate.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyloctadecylamine N-oxide

EC Number:

219-919-5

EC Name:

N,N-dimethyloctadecylamine N-oxide

Cas Number:

2571-88-2

Molecular formula:

C20H43NO

IUPAC Name:

N,N-dimethyloctadecanamine oxide

Test material form:

liquid

Details on test material:

Test material is skin lotions containing 2.5% C18 DMAO.
Other ingredients were: 35% of either mineral oil or isopropyl palmitate, 1% cetyl alcohol, 1% lanolin, with or without 0.2% quaternary preservative (50:50 mixture of alkyl dimethyl benzyl ammonium chloride and alkyl dimethyl ethylbenzyl ammonium chloride); the balance was water

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: skin lotion

Controls:

not specified

Amount / concentration applied:

2.5%

Duration of treatment / exposure:

72 hours

Observation period:

14 days

Number of animals:

1-3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Lotion 1 (mineral oil, no quat)

Basis:

mean

Time point:

72 h

Score:

ca. 4

Reversibility:

not specified

Remarks on result:

other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Lotion 2 (mineral oil, quat)

Basis:

mean

Time point:

72 h

Score:

ca. 6

Reversibility:

not specified

Remarks on result:

other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Lotion 3 (isopropyl palmitate, no quat)

Basis:

mean

Time point:

72 h

Score:

ca. 0

Reversibility:

not specified

Remarks on result:

other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Lotion 4 (isopropyl palmitate, quat)

Basis:

mean

Time point:

72 h

Score:

ca. 0

Reversibility:

not specified

Remarks on result:

other: 2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

2.5% C18 Amine Oxide did not impact the irritation profile of these skin lotions

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for primary skin irritation in rabbits. The authors demonstrated the minimal to moderate skin irritation observed with two of the four formulas was due to the presence of 35% mineral oil with a single variable substitution with 35% isopropyl palmitate. All of the skin lotions contained 2.5% C18 AO, only those with mineral oil were skin irritants.

Executive summary:

N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) was evaluated for primary skin irritation in rabbits. The authors demonstrated the minimal to moderate skin irritation observed with two of the four formulas was due to the presence of 35% mineral oil with a single variable substitution with 35% isopropyl palmitate. All of the skin lotions contained 2.5% C18 AO, only those with mineral oil were skin irritants.