Quaternary ammonium compounds, C18-22 (even numbered) alkyltrimethyl, chlorides; Docosyltrimethylammonium chloride; C18-22 TMAC

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 18, 2008 to April 22, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000) including the most recent partial revisions

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

EC Number:

271-756-9

EC Name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

Cas Number:

68607-24-9

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 7 - 13 weeks old
- Weight at study initiation: 1492-2366 g
- Housing: Individually in labelled cages with perforated floors (dimensions 56x44x37.5 cm)
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 - 21.4
- Humidity (%): 44 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: moistened with water

Controls:

not required

Amount / concentration applied:

TEST SUBSTANCE
- Amount(s) applied (volume or weight with unit): 500 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2x3 cm
- % coverage: 100
- Type of wrap if used: mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 2

Irritation parameter:

edema score

Remarks:

Mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 3

Irritation parameter:

erythema score

Remarks:

Mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 4

Irritation parameter:

erythema score

Remarks:

Mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

other: on day 7 reached score 4

Results 5

Irritation parameter:

erythema score

Remarks:

Mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 6

Irritation parameter:

erythema score

Remarks:

Mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

other: on day 7 reached score 4

Irritant / corrosive response data:

Four hours exposure to 0.5 g of the test substance resulted in moderate to severe or severe erythema and very slight or slight oedema in the treated skin-areas of the three rabbits. In all animals, the observed erythema was scattered at 48 and/or 72 h after exposure. Fissuring of the skin was noted at 7 days after exposure in two animals and these animals showed scaliness at 7 and 14 days after exposure and bald skin at 14 days after exposure. The other animal showed scaliness at 7 days after exposure. The skin irritation had resolved within 14 days after exposure, except for scaliness and bald skin in two animals. There was no evidence of a corrosive effect on the skin.

Other effects:

No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Animal		778^1				757				803
Time after exposure		Erythema	Oedema	comments		Erythema	Oedema	comments		Erythema	Oedema	comments
1 hour		2	1			1	1			2	1
24 hours		3	1			2	2			2	1
48 hours		3	1	v		2	2			2	1	v
72 hours		3	1	v		3	1	v		2	0	l,v
7 days		4	-	g,l		1	1	l		4	-	g,l
14 days		0	0	h,l		0	0			0	0	h,l

¹Sentinel.

 

Comments:

-.      No scoring possible due to fissuring of the skin

g.     Fissuring of the skin.

h.     Bald skin.

l.      Scaliness.

v.     Scattered erythema.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) based on CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be irritating to rabbit skin following 4 h of exposure.

Executive summary:

A study was conducted to determine the skin irritation / corrosion of the test substance, C20 -22 TMAC (active: 97.8%), according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. In the study, 0.5 g of the test substance moistened with water was applied under semi-occlusive patches to the shaved dorsal area of three rabbits. The test sites were examined for evidence of primary irritation and scored according to Draize method. Four hours exposure to 0.5 g of the test substance resulted in moderate to severe or severe erythema and very slight or slight oedema in the treated skin-areas of the three rabbits. In all animals, the observed erythema was scattered at 48 and/or 72 h after exposure. Fissuring of the skin was noted at 7 d after exposure in two animals and these animals showed scaliness at 7 and 14 d after exposure and bald skin at 14 d after exposure. The other animal showed scaliness at 7 d after exposure. The skin irritation had resolved within 14 d after exposure, except for scaliness and bald skin in two animals.No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of test substance to the intact rabbit skin. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Under the study conditions, the test substance was considered to be irritating to rabbit skin following 4 h of exposure (Stitzinger, 2008).