1-Tetradecanaminium, N,N,N-trimethyl-, ethanedioate (2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-02-17 to 2004-04-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented guideline conform, scientific GLP report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecyltrimethylammonium oxalate

IUPAC Name:

Tetradecyltrimethylammonium oxalate

Constituent 2

Reference substance name:

-

EC Number:

453-080-8

EC Name:

-

Cas Number:

154858-16-9

Molecular formula:

C36H76N2O4

IUPAC Name:

bis(trimethyl(tetradecyl)azanium) oxalate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g test item pasted with 0.4 mL deionized water

Duration of treatment / exposure:

3 minutes (left front flank)
1 hour (left hind flank)

Observation period:

30 -60 minutes, 24, 48, 72 hours and 7, 14, and 21 days after patch removal

Number of animals:

one

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft), covered with semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM: DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: 3 minute exposure

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 72 hours

Score:

2.17

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: 1 hour exposure

Any other information on results incl. tables

Table: Summary Skin irritation results:

Duration Treatment: 3 minutes (left front flank)
Female #281	Time after Treatment	Erythema	Edema
	30-60 min	0	0
	24 hrs	0	0
	48 hrs	0	0
	72 hrs	0	0
Duration Treatment: 1 hour (left hind flank)
Female #281	Time after Treatment	Erythema	Edema
	30-60 min	1	0
	24 hrs	2	2
	48 hrs	2	2
	72 hrs	3	2
	7 days	3	2
	14 days	2	0
	21 day	2	0

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this OECD 404 study the test substance is corrosive to skin (causes burns).

Executive summary:

In order to test the skin irritation/corrosive properties of the test item, an OECD 404 test was performed with New Zealand White rabbits. 24 hours prior to treatment the hair of the dorsal region of the body of one rabbit was removed with an electric clipper over an area of about 25 cm2. One animal was treated sequentially with each 0.5 g of the test substance pasted with 0.4 mL deionized water for exposure periods of 3 minutes (left front flank) and 1 hour (left hind flank). The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area, and for the 1 hour exposure, covered with a semiocclusive bandage. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin areas took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because of persistent irritations 72 hours after removal of the patch, additional readings were performed after 7, 14 and 21 days. Because of corrosion after treatment for 1 hour no further animals were used.

The results were evaluated numerical according to the score of DRAIZE. After the 3 minutes exposure period, no signs of irritations were observed during the study. After the 1 hour exposure period the following observations were described: 30 - 60 minutes up to 21 days after removal of the patches the treated skin of the animal showed very slight up to moderate or severe erythema and slight edema. Additionally, encrusted skin, coarse scales, as well as dry, rough and parchment-like skin surface were observed. 21 days after removal of the patch, the irritations had not disappeared and scar formation was noted in the skin indicating irreversible skin damage.