Reaction mass of 2-hydroxy-3-[(1-oxodocosyl) oxy]propyltrimethylammonium chloride and 2-methylpentane-2,4-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No data on test animals and environmental conditions, 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, full reversibility not observed.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No data on test animals and environmental conditions, 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, full reversibility not observed.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

EC Number:

274-033-6

EC Name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

Cas Number:

69537-38-8

Molecular formula:

C28H58NO3.Cl

IUPAC Name:

3-(docosanoyloxy)-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Constituent 2

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

Test material form:

solid

Remarks:

paste

Details on test material:

- Description: White pasty product
- Date of receipt: 10 September 1980

Specific details on test material used for the study:

Test substance was tested pure and undiluted

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact or abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 h after the application of the test substance

Number of animals:

6 animals - intact skin
6 animals - abraded skin

Details on study design:

PRE-TREATMENT
24 hours prior to the test, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.

TEST SITE
- Area of exposure: Test substance was applied on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch.
- Type of wrap if used: The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material.

OBSERVATION TIME POINTS
24 and 72 h after the application of test substance

SCORING SYSTEM:
Skin reactions were evaluated by the method of Draize, 1944

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

intact skin

Time point:

other: 24 and 72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- Test substance caused slight to moderate skin irritation. Its dermal effects generally consisted of very slight or well-defined erythema, very slight edema and slight scaliness.
- There were no significant differences between skin reactions of the intact skin and those of the abraded skin.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual and average skin irritation scores

Rabbit No.	Intact skin				Rabbit No.	Abraded skin
	Erythema		Edema			Erythema		Edema
	24 h	72 h	24 h	72 h		24 h	72 h	24 h	72 h
1	3	1	1	0	7	0	0	0	0
2	2	1	1	0	8	2	1	1	0
3	1	0	0	0	9	1	0	0	0
4	2	1	1	0	10	2	1	1	0
5	2	1	1	0	11	1	1	1	0
6	2	2	1	1	12	2	1	1	0
Total	12	6	5	1	Total	8	4	4	0
Mean (24 and 72 h)	1.5		0.5		Mean (24 and 72 h)	1.0		0.3

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and classified in Cat.3 (mild skin irritation) according to the GHS.

Executive summary:

In a dermal irritation study, undiluted test substance was dermally applied on the intact or abraded side surface of 12 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the application of test substance.

 

Test substance caused slight to moderate skin irritation. Its dermal effects generally consisted of very slight or well-defined erythema, very slight edema and slight scaliness. There were no significant differences between skin reactions of the intact skin and those of the abraded skin. Mean scores were 1.5 for erythema and 0.5 for edema (intact skin) and 1.0 for erythema and 0.3 for edema (abraded skin).

 

Under the test conditions, test substance is not classified according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) ant classified in Cat.3 according to the GHS.

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for skin irritation endpoint.