N,N-Bis(2-hydroxyethyl)-C12-18(even numbered, C18 unsaturated) alkyl-1-amine oxides

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The procedure employed was used to classify the test item according to the recommendations given in the Transport of Dangerous Goods, Special Recommendations Relating to Class 8 United Nations Handbook, 1977.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-Bis(2-hydroxyethyl)-C12-18(even numbered, C18 unsaturated) alkyl-1-amine oxides

EC Number:

942-293-6

Molecular formula:

not applicable

IUPAC Name:

N,N-Bis(2-hydroxyethyl)-C12-18(even numbered, C18 unsaturated) alkyl-1-amine oxides

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

- Name of test material (as cited in study report): Aromox c/12-w
- Analytical purity: 36% in water

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

other: occluded with "sleek" plaster

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

the test material corresponds to 36% registration substance in water

Controls:

not required

Amount / concentration applied:

0.5 ml of test material (36% regstration substance in water) on skin area of 2.5 x2.5 cm

Duration of treatment / exposure:

Preliminary investigation: 3, 30, 60 and 4 hours
Conformatory investigation: 4 hours

Observation period:

up to 72 hours

Number of animals:

One for the preliminary, three for the conformatory intestigations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: necrosis

Basis:

animal: used in preliminary study

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Preliminary investigations (Table 1):

Well-defined erythema with very slight or slight oedema developed at the 60 minutes and 4 hours exposure sites at the 24 hours reading.

By the 48 hours reading, the dermal reactions had ameliorated to very slight erythema and oedema at the 60 minutes exposure site but had progressed to severe necrotic lesions with slight oedema at the 4 hours exposure site. The necrotic lesions persisted at the 72 hours reading.

No dermal reactions were recorded at the 3 and 30 minutes exposure sites.

 

Confirmatory study (Table 2)

Very slight or well-defined erythema with or without very slight or slight oedema was seen at both sites of all three rabbits at the 24 hours reading. These dermal reactions were also recorded at three sites at the 48 hours reading and six sites at the 72 hours reading.

 

 

 

Table 1: Preliminary investigation
Exposure Time	Reaction	Time after removal of patch
		0 hour	24 hours	48 hours	72 hours
3 min	erythema	0	0	0	0
	oedema	0	0	0	0
30 min	erythema	0	0	0	0
	oedema	0	0	0	0
60 min	erythema	0	2	1	0
	oedema	0	1	1	0
4 hours	erythema	0	2	4	4
	oedema	0	2	2	2

 

 

 

Table 2: Confirmatory study
Rabbit	Reaction	Time after removal of patch
		0 hour		24 hours		48 hours		72 hours
		Site 1	Site 2	Site 1	Site 2	Site 1	Site 2	Site 1	Site 2
A	erythema	0	0	2	2	2	2	2	2
	oedema	0	0	2	2	2	2	2	2
B	erythema	0	0	1	1	0	0	1	1
	oedema	0	0	0	1	0	0	0	0
C	erythema	0	0	1	1	0	1	1	1
	oedema	0	0	0	1	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

The skin irritation property of the registration substance formulation (36% in water) was tested equivalent to OECD 404. After 4 hours exposure, the treated animals exhibited either necrosis or effects that was not fully reversible within 72hours of observation period. It is justified to assign R 34 for the registration substance according to 67/548/EEC(DSD), or Cat 1C according to GHS.

Executive summary:

The skin irritation property of the registration substance formulation (36% in water) was tested equivalent to OECD 404. After 4 hours exposure, the treated animals exhibited either necrosis or effects that was not fully reversible within 72 hours of observation period. After up to 1 hour exposure, no or reversible irritating effects were observed. It is justified to assign R 34 for the registration substance according to 67/548/EEC(DSD), or Skin Corr. Cat 1C according to GHS.