N,N-dimethyltetradecylamine N-oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-10-22 to 1997-11-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyltetradecylamine N-oxide

EC Number:

222-059-3

EC Name:

N,N-dimethyltetradecylamine N-oxide

Cas Number:

3332-27-2

Molecular formula:

C16H35NO

IUPAC Name:

dimethyl(tetradecyl)amine oxide

Details on test material:

Ammonyx MO

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kulper Rabbitry, Gary, Indiana USA
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 2120 - 2370 g
- Housing: stainless steel cages
- Diet (e.g. ad libitum): Purina rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
Environmental conditions were not specified but cages were maintained in a temperature, humidity and light controlled room.

IN-LIFE DATES: From: 1997_10_22 To: 1997_11_6

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6 male

Details on study design:

TEST SITE
- Area of exposure: 6 cm square
- % coverage: no data
- Type of wrap if used: 2 layer gauze patch held in place with non-irritating Kendall Curity Standard Porous Tape and then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standarf Porous Tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean of 24, 48 & 72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean of 24, 48 & 72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean of 24, 48 & 72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: mean of 24, 48 & 72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: mean of 24, 48 &72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: mean of 24, 48 & 72 hrs

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean of 24, 48 &72 hrs

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean of 24, 48 & 72 hrs

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean of 24, 48 & 72 hrs

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: mean of 24, 48 & 72 hrs

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: mean of 24, 48 & 72 hrs

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: mean of 24, 48 & 72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

Coriaceousness and slight fissuring on all at 48 hours
Coriaceousness and slight fissuring on all at 72 hours
Some scaling of epidermis on all at 168 hours.

Any other information on results incl. tables

Rabbit #	Initial bwt (g)	Final bwt (g)	Sex	ER 4.5	ED 4.5	ER 24	ED 24	ER 48	ED 48	ER 72	ED 72	ER 168	ED 168	ER 336	ED 336
403	2040	2260	M	2	1	2	3	3	3	4	1	1	0	0	0
404	2120	2375	M	2	0	2	1	3	2	4	1	2	0	0	0
405	2200	2490	M	1	0	2	2	3	2	4	1	1	0	0	0
406	2070	2250	M	1	1	2	2	3	2	4	2	1	0	0	0
407	2140	2400	M	2	1	2	2	3	2	4	1	2	0	0	0
408	2155	2480	M	1	1	2	1	3	1	4	1	2	0	0	0
		Ave:		1.5	0.67	2.0	1.83	3.0	2.0	4.0	1.17	1.5	0	0	0
		Total		2.17		3.83		5.0		5.17		1.50		0

ER: Erythema

ED: Oedema

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is highly irritating to the skin of rabbits under the conditions of the study.

Executive summary:

In an OECD 404 Guideline study for acute skin irritation, the substance tested as provided was highly irritating to the skin of rabbits.