1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

454-210-6

EC Name:

-

Cas Number:

13106-24-6

Molecular formula:

C13 H30 N . C H3 O4 S

IUPAC Name:

tributyl(methyl)azanium methyl sulfate

Details on test material:

Substance Number: 97/272
Batch number: 601
Degree of purity: 101 g/100 g (H-NMR)
Physical state/appearance: Solid (congealed melt), white
Storage conditions: Room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals: New Zealand White (SPF)
Age: Young adult animals
Acclimatization period: At least one week.
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees celsius for temperature and of 30-70 % relative humidity. There were no deviations from these ranges wgich influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 A.M. - 6.00 P.M./6.00 P.M. - 6.00 A.M.)
Type of cage: Stainless steel wire mesh cages with grating, floor area 3000 cm2.
No. of animals per cage: Single housing.
Bedding: No bedding in the cages; sawdust in the waste trays.
Drinking water: About 250 ml tap water per animal per day.
Diet: Kliba-Labordiet, Klingentalmuehle AG, Kaiseraugst, Switzerland. About 130 g per animal per day.
Analysis of drinking water: The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory.
Analysis of feed: The feed used in the study was assayed for chemical and microbiological contaminants.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping of the fur

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 ml of test substance

Duration of treatment / exposure:

4 h

Observation period:

15 days

Number of animals:

3

Details on study design:

At least 24 hours before the test, the fur was removed by clipping the dorsal part of the trunk of the animals. Only animals with healthy intact skin have been used.
Weight determination: Shortly before application of the test substance.
Route of application: The test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol(R) and Lutrol(R)/Water (1:1).
Application volume: The test patch (2.5x2.5 cm) was moistened with a dose of 0.5 ml of the at about 80 centrigrade heated test substance. Before application it was cooled down to body temperature.
Application side: Upper third of the back or flanks.
Readings: 1 h, 24 h, 48 h. 72 h, 8 d, and 15 d after removal of the patch.
Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays, and on public holidays.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

1.2

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1.3

Reversibility:

not fully reversible within: 15 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

1.3

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0