Dodecyldimethylamine oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978-09-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

- Treatment time is 24 hours instead of 4 hours. 0.4ml of test substance dosed instead of 0.5ml. Systemic toxicity, body weight and histopathology results are not given.

Principles of method if other than guideline:

None

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides

EC Number:

931-292-6

Molecular formula:

CnH(2n+3)NO, where n=14/16

IUPAC Name:

Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides

Details on test material:

- Name of test material (as cited in study report): P0434 (dodecyl dimethyl amine oxide)
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): 235.7
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: Not available
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: Not available
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kings wheel
- Age at study initiation: Not available
- Weight at study initiation: 2058.9 - 3285.9 gm
- Housing: Individually in stainless steel cages with stainless steel slatted flooring
- Diet (e.g. ad libitum): Purina lab rabbit chow
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: Minimum 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4°C - 21.1°C
- Humidity (%): 72%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours on/off fluorescent lighting


IN-LIFE DATES: 1978-09-21

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 ml of P0434
- Concentration (if solution): Undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of treatment / exposure:

0.4 ml of undiluted P0434 was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits
using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and
72 hours.

Observation period:

24 and 72 hours

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: Back of animals (right side - abraded, left side - intact)
- % coverage: Test substance applied using Parke-Davis Readi-Bandage
- Type of wrap if used: Gauze and elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites wiped with wet paper towel
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize method
Erythema and eschar scoring from 0-4 with 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth).
Edema scoring from 0-4 with 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite raising), 3 = moderate edema (raised approximately 1mm), 4 = severe edema (raised more than 1 mm nd extending beyond the area of exposure).
Primary irritation index: 0-2 = mild, 2-5 = moderately irritating, 5-6 = moderately to severely irritating, 6-8 = severely irritating

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was observed

Remarks on result:

other: intact skin site

Results 10

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: intact skin site

Results 11

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 12

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other:

Remarks:

intact skin site

Results 13

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: intact skin site

Results 14

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 15

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: intact skin site

Results 16

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: intact skin site

Results 17

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

intact skin site

Results 18

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: intact skin site

Results 19

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hours

Score:

1.67

Max. score:

8

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: Intact and abraded skin site

Results 20

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

4

Max. score:

8

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: Intact and abraded skin site

Results 21

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: abraded skin site

Results 22

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

in 72 hours

Remarks on result:

other: abraded skin site

Results 23

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Reversibility:

other: No edema was observed

Remarks on result:

other: abraded skin site

Results 24

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No edema was observed

Remarks on result:

other: abraded skin site

Irritant / corrosive response data:

For intact and abraded skin site at 24 hours PII is 1.67 and at 72 hours PII is 4.0.

Other effects:

None reported

Any other information on results incl. tables

Animal No.	Skin site	Degree of erythema after---- [Observation time]		Degree of edema after---- [Observation time]		Ø 24/72 h >= 2.3 but < 4.0
		24 h	72 h	24 h	72 h	Erythema	Edema
	Intact
RB 608 78		1	4	0	0	Yes	No
		Ø 24/ 72 h = 2.5		Ø 24/ 72 h = 0		=> Positive responder
RB 524 78		2	4	0	0	Yes	No
		Ø 24/ 72 h = 3.0		Ø 24/ 72 h = 0		=> Positive responder
RB 525 78		2	4	0	0	Yes	No
		Ø 24/ 72 h = 3.0		Ø 24/ 72 h = 0		=> Positive responder
	Abraded
RB 608 78		1	4	0	0	Yes	No
		Ø 24/ 72 h = 2.5		Ø 24/ 72 h = 0		=> Positive responder
RB 524 78		2	4	0	0	Yes	No
		Ø 24/ 72 h = 3.0		Ø 24/ 72 h = 0		=> Positive responder
RB 525 78		2	4	0	0	Yes	No
		Ø 24/ 72 h = 3.0		Ø 24/ 72 h = 0		=> Positive responder

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Conclusions:

P0434 (27.8% DDAO) is classified as a Category 2 skin irritant according to EU GHS classification.

Executive summary:

0.4 ml of undiluted P0434 (27.8% DDAO) was applied to one abraded and one intact test site on each of the three female New Zealand white rabbits using Parke Davis Readi-bandage secured with hypo-allergenic tape. Test sites were wrapped with gauze and elastoplast tape for 24 hours. After 24 hours the test sites were wiped with a wet paper towel. The sites were examined for erythema and edema using Draize method of scoring at 24 and 72 hours.

Very slight to well-defined erythema at the intact and abraded sites of all the test animals at 24 hours. At 72 hours severe erythema (beet redness) to slight eschar formation (injuries in depth) were observed at the intact and abraded of all the test animals. No edema was observed at any time point.

Thus, 27.8% DDAO/ C10-C16 alkyldimethyl, N-Oxide is classified as a Category 2 skin irritant according to EU GHS classification.