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

Endpoint summary

Description of key information

The registration substance at 36% in water was investigated for skin and eye irritation properties according/equivalent to OECD 404 and OECD 405 respectively. The registration substance induced severe irritating/corrosive effects. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

New Zealand White

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.

Irritation parameter:

other: necrosis

Basis:

animal: used in preliminary study

Remarks on result:

positive indication of irritation

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

other: reported as "male albino rabbit"

Vehicle:

unchanged (no vehicle)

Remarks:

the test material corresponds to 36% registration substance in water

Controls:

not required

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

up to seven days

Number of animals or in vitro replicates:

6

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #4

Time point:

7 d

Score:

86

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Rabbit eye irritation scores: Rabbit no. 1
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	0	5	5	0
Iris	0	0	0	5	5	5
Conjuctivae	6	8	8	6	4	4
Total	6	8	8	16	14	9

Rabbit eye irritation scores: Rabbit no. 2
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	0	5	20	45
Iris	0	0	0	5	5	5
Conjuctivae	8	8	14	14	12	16
Total	8	8	14	24	37	66

Rabbit eye irritation scores: Rabbit no. 3
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	0	0	0	0
Iris	0	0	0	5	5	5
Conjuctivae	6	8	6	8	6	6
Total	6	8	6	13	11	11

Rabbit eye irritation scores: Rabbit no. 4
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	10	20	40	60
Iris	0	0	5	5	5	10
Conjuctivae	6	12	14	16	16	16
Total	6	12	29	41	61	86

Rabbit eye irritation scores: Rabbit no. 5
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	0	5	20	30
Iris	0	0	0	5	5	5
Conjuctivae	6	8	8	10	12	14
Total	6	8	8	20	37	49

Rabbit eye irritation scores: Rabbit no. 6
	Hours after treatment [h]
	1	24	48	72	96	168
Cornea	0	0	0	5	20	10
Iris	0	0	0	5	5	5
Conjuctivae	6	6	6	8	12	14
Total	6	6	6	18	37	29

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

Executive summary:

The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

It is justified to assign R 41 for the registration substance according to 67/548/EEC(DSD), or Eye Dam.1 according to GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

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 only reversible irritating effects were observed. It is justified to assign Skin Corr. Cat 1C according to GHS.

 

Eye irritation:

The registration substance at 36% was investigated for its eye irritation property (method applied was equivalent to OECD 405). Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

It is justified to assign Eye Dam.1 according to GHS.

Justification for selection of skin irritation / corrosion endpoint:
Scientifically well-performed study

Justification for selection of eye irritation endpoint:
Scientifically well-performed study

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the obtained experimental results, it is justified to assign  Skin Corr. Cat 1C and Eye Dam. 1 according to GHS.