Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides

EC Number:

268-074-9

EC Name:

Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides

Cas Number:

68002-61-9

Molecular formula:

Representative molecular formula of the major constituents, as the substance is an UVCB: C16 TMAC: C19H42CL1N1 C18 TMAC: C21H46CL1N1 C18-unsatd. TMAC: C21H44CL1N1

IUPAC Name:

Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl) trimethyl, chlorides

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL of undiluted test substance (50% pure)

Duration of treatment / exposure:

4 or 1 h

Observation period:

4 or 1 hour, 48 h and 10 days

Number of animals:

Six males and females

Details on study design:

Six healthy adult New Zealand White albino rabbits (M/F) were used for the test. 24 hours prior to applying the test substance, the hair was removed from the back of the animals with electric clippers in such a way as to avoid abrasions.

An amount of 0.5 mL of the undiluted test substance was brought on the intact skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.

Each rabbit was treated on the intact skin. The abrasions were minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

After an exposure period of 4 or 1 hour the patches and the test substance applied were removed and the resulting skin reactions were evaluated by the method of Draize scoring. A second reading was made 48 hours later.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

ca. 0.85

Max. score:

8

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Study II, following exposure period of 1 hour

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 h

Score:

4

Max. score:

8

Reversibility:

not reversible

Remarks:

within 10 days

Remarks on result:

other: Study I, following exposure period of 4 hours

Results 3

Irritation parameter:

erythema score

Remarks:

4 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 3.84

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Remarks on result:

other: well-defined to moderate erythema

Results 4

Irritation parameter:

erythema score

Remarks:

1 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 1.08

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: very slight to moderate erythema

Results 5

Irritation parameter:

edema score

Remarks:

1 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 10 dys

Remarks on result:

other: very slight to slight edema

Results 6

Irritation parameter:

edema score

Remarks:

4 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 1.58

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Remarks on result:

other: very slight or slight edema

Results 7

Irritation parameter:

overall irritation score

Remarks:

4 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 5.4

Max. score:

8

Reversibility:

not reversible

Remarks:

within 10 days

Remarks on result:

other: Corrosive to skin

Results 8

Irritation parameter:

overall irritation score

Remarks:

1 h exposure

Basis:

mean

Time point:

48 h

Score:

ca. 1.25

Max. score:

8

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: corrosive to skin

Results 9

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Observations in 4 hours test:
- After 4 hours: Very slight to well-defined erythema, very slight ischemia and very slight edema
- After 48 hours: Well-defined to moderate erythema, very slight to slight ischemia and very slight or slight edema
- After 10 days: Slight to distinct incrustation and decreased hair growth

Observations in 1 h test:
After 1 h: Very slight erythema
After 48 h: Very slight to moderate erythema and very slight or slight edema
After 10 d: No skin effects were observed

Any other information on results incl. tables

For result tables, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Interpretation of results:

other: Category 1C based on CLP criteria

Conclusions:

Under the study conditions, the undiluted test substance (i.e., 50% active ingredient) was considered to be corrosive to the rabbit skin after 4 h of occlusive exposure.

Executive summary:

A study was conducted to determine the skin irritation potential of the test substance, C16 -18 and C18 -unsatd. TMAC (50% active) in rabbits, according to a method similar to OECD Guideline 204. Six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% active ingredient) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 h. Observations were made at 4 h, 48 h and 10 days post-exposure. If the test substance appeared to be corrosive after 4 h, another study was conducted with a 1 h exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 h, very slight to well-defined erythema, very slight ischemia and very slight oedema were observed, with an average irritation score of 4/8. At 48 h, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight oedema and the average irritation score was 5.4/8. After 10 days, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 h, very slight erythema was observed with an average irritation score of 0.85/8. After 48 h, there was very slight to moderate erythema and very slight or slight oedema and the average irritation score was 1.25/8. No skin effects were observed after 10 days. Under the study conditions, the undiluted test substance (50% active ingredient) was corrosive after 4 h of occlusive exposure.