Fatty acids, C16-18 (even numbered), reaction products with diethylene triamine, di-Me sulfate quaternized

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-02-02 to 1984-03-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: HLD Versuchsplan P 2/152, Revision 5, regulations of US Food and Drug Administration (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), den FDA Good Laboratory Practice Regulations

Version / remarks:

1959

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Richtlinien fiir Hautverträglichkeitsprüfungen am Kaninchen (Januar 1981) der US lnteragency Regulatory Liaison Group (IRLG)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Imidazolium compounds, 2-(C15 and C17)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro, Me sulfates

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Imidazolium compounds, 2-(C15 and C17)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro, Me sulfates

Constituent 2

Reference substance name:

Imidazolium compounds, 2-(C15 and C17 -alkyl)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro-(1 or 3)-methyl, Me sulfates

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Imidazolium compounds, 2-(C15 and C17 -alkyl)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro-(1 or 3)-methyl, Me sulfates

Constituent 3

Reference substance name:

N,N,N-trimethyl-2-[2-(C15 and C17)]-4,5-dihydro-1H-imidazol-1-yl)ethanaminium, Me sulfates

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

N,N,N-trimethyl-2-[2-(C15 and C17)]-4,5-dihydro-1H-imidazol-1-yl)ethanaminium, Me sulfates

1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

2

Reference substance name:

Glycerides, C16-18 mono-

EC Number:

293-208-8

EC Name:

Glycerides, C16-18 mono-

Cas Number:

91052-47-0

Molecular formula:

C19H38O4 to C21H42O4

IUPAC Name:

Glycerides, C16-18 mono-

Test material form:

other: yellowish paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Züchter H. Fortkamp, 4540 Lengerich
- Age at study initiation: 11-17 weeks
- Weight at study initiation: 1.90 - 2.80 kg
- Housing: individually in Steel cages with perforated metal floors over trays with bedding
- Diet (e.g. ad libitum): ad libitum, SSniff K, Alleindiät für Kanninchen, Ssniff Versuchstier-Diäten GmbH, 4770 Soest
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

72 h, with reading intervals of 24 h and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze covered with a self-adhesive, impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: After 24 h the substance was removed with disposable wipes.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize, J. H., (1959), Association of Food and Drug Officials of the US, Austin, Texas, "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timpoints measured

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 8

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 10

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 12

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

only two timepoints measured

Results 13

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two timepoints measured

Results 14

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two timepoints measured

Results 15

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two timepoints measured

Results 16

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two timepoints measured

Results 17

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two time points measured

Results 18

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Remarks:

only two timepoints measured

Results 19

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 20

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 21

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 22

Irritation parameter:

edema score

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 23

Irritation parameter:

edema score

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 24

Irritation parameter:

edema score

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no indication for irritation

Remarks on result:

no indication of irritation

Remarks:

only two timepoints measured

Results 25

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 26

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 27

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 28

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 29

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 30

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Results 31

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 32

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 33

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 34

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 35

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 36

Irritation parameter:

edema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
24 h	2/2/2/2/2/2	1/1/1/1/1/1
72 h	2/2/2/2/2/2	0/0/0/0/0/0
Average 24h, 72h	2/2/2/2/2/2	0.5/0.5/0.5/0.5/0.5/0.5
Reversibility*)	n.c.	c.
Average time (h) for reversion	n.d.	72 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible, n.d. = not determined

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In the present test 6 New Zealand rabbits were dermally exposed to 0.5 g of the test item for 24h under occclusive conditions. All animals showed moderate erythema up to 72h after patch removal. Edema formation was observed in all six animals but was fully reversible within 72h. Based on these results the substance needs to be classified as Category 2 - irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

Executive summary:

In a primary dermal irritation study according to HLD Versuchsplan P 2/152, Revision 5, regulations of US Food and Drug Administration (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), den FDA Good Laboratory Practice Regulations) and Richtlinien für Hautverträglichkeitsprüfungen am Kaninchen (Januar 1981) der US lnteragency Regulatory Liaison Group (IRLG),6 young adult New Zealand rabbitswere dermally exposed to 0.5 gofhydrogenated tallow/nortallow based IQACfor24hours under occlusive conditions.  Animals then were observed for72 hours.  Irritation was scored by the method of(Draize, JH, (1959)).

 All animals showed moderate erythema up to 72h after patch removal. Edema formation was observed in all six animals but was fully reversible within 72h.In this study,hydrogenated tallow/nortallow based IQAC isa dermal irritant. Based on these results the substance needs to be classified as Category 2 - irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).