(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Patch-test technique
- Short description of test conditions: Skin irritation was tested on abraded and intact skin of albino rabbits. 0.5 mg was brought on the intact or abraded skin of 6 rabbits each under a surgical patch measuring 1 inch x inch under occlusive conditions. After 24 hours exposure the patches were removed and skin reactions were evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application).
- Parameters analysed / observed: erythema and edema grades

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

EC Number:

261-684-6

EC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Cas Number:

59272-84-3

Molecular formula:

C21H42N2O3

IUPAC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

intact and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mg

Duration of treatment / exposure:

24 hours

Observation period:

immediately after end of treatment and after 48 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: not specified
- Type of wrap if used: adhesive tape and the entire trunk was wrapped with an impervious material

REMOVAL OF TEST SUBSTANCE
- Washing: not specified, the report states: material was removed
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
After an exposure period of 24 hours the skin was evaluated immediately and 48 hours later (72 hours after application)

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 5

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 8

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 9

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 10

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 11

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 12

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

The dermal effects generally observed consisted of very slight or well-defined erythema, with or without very slight edema. In addition, after 72 hours one intact and one abraded application site showed moderate incrustation and the other intact and abraded application sites generally showed slight scaliness. One rabbit out of 6 showed a more severe erythema and edema score after 72 hours compared to the 24-hour reading. All other animals the scores decreased or stayed the same. There were no distinct differences between reactions of the intact skin and those of the abraded skin.

Other effects:

none

Any other information on results incl. tables

Table 1: Individual scores (intact skin)

Observation time	Rabbit no
	1		2		3		4		5		6
	erythema	edema	erythema	edema	erythema	edema	erythema	edema	erythema	edema	erythema	edema
24 h	2	1	2	1	1	0	2	0	0	0	1	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence effecs seen at 24 h over 48 h)
72 h	1	0	4	2	0	0	1	0	0	0	1	0
Mean value 24 + 48+ 72 h	1.67	0.67	2.67	1.33	0.67	0	1.67	0	0	0	1	0

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

On the basis of the present results and expert judgement it can be concluded that the test substance is not irritating to skin according to Regulations (EC) No 1272/2008. The exposure to the pure test substance on intact skin of 6 rabbits for 24 hours resulted in dermal effects generally observed consisted of very slight or well-defined erythema, with or without very slight edema. In addition, after 72 hours one animal showed moderate incrustation and another application site generally showed slight scaliness. In one out of six animals the severity of erythema and edema increased from the 24- to the 72 hour reading. Taking into account that the exposure lasted 24 hours instead of 4 hours under occlusive conditions instead of semiocclusive conditions this treatment can be considered as worst case. Only one out of six animals showed a mean erythema score above 2.3. Additionally, in an acute dermal toxicity testing the test substance applied as a 25% solution for 24 hours under occlusive conditions did not show any signs of skin irritation. Thus, under these worst case conditions it can be assumed that under guideline testing conditions no or only slight skin irritation would have been observed.