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

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

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
- Molecular formula (if other than submission substance): 36% in water

Test animals / tissue source

Species:

rabbit

Strain:

other: reported as "male albino rabbit"

Test system

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

Results and discussion

In vivo

Results

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.