Fatty acids, C16-18 and C18-unsatd., reaction products with triethanolamine, 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:

2010-04-12 to 2010-05-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Cas Number:

91995-81-2 / 157905-74-3 / 93334-15-7

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Test material form:

other: solid paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The right flank remained untreated and served as a control.

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1 hour and 24, 48, 72 hours 7, 14 and 21 days after application of the test substance.

Number of animals:

3 animals, 1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: Samples of 0.5 g of the test substance have been put on a gauze pad and spread over an area of 2 cm x 3 cm; the gauze pad then was applied to the skin.
- % coverage: One gauze pad of 4 cm x 5 cm size (Askina® Brauncel, B. Braun Petzold GmbH, Melsungen, Germany) with test substance was applied to the left flank of one animal. It was held in place by strips of Micropore (3M company, St. Paul, USA). The semi-occlusive dressing was bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure skin was cleaned carefully with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: as stipulated by OECD guideline 404, 2002

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation
(grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible
erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was
reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after
application. 21 days after application, all three animals were without any sign of skin irritation.

Other effects:

No symptoms of toxicity caused by the test substance or any unusual finding were observed.

Any other information on results incl. tables

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
60 min	1/2/1	0/0/0
24 h	2/2/1	1/1/0
48 h	2/2/1	2/2/1
72 h	2/2/1	2/2/1
7 days	1/1/0	1/1/0
14 days	0/0/0	0/0/0
Average 24h, 48h, 72h	2/2/1	1.67/1.67/0.67
Reversibility*)	c/c/c	c/c/c
Average time (unit) for reversion	14 days	14 days

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

Desquamation persists at the 14 day observation, but was fully reversible at study day 21.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
No classification for skin irritation is justified for the partially unsaturated TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404, three New Zealand White rabbits, were semi-occlusive dermally exposed to 0.5 g of the partially unsaturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Irritation was scored by the method as stipulated by OECD Guideline 404. Animals were than observed for 21 days.

 

Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation (grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after application. 21 days after application, all three animals were without any sign of skin irritation.