1-Butanaminium, 4-hydroxy-N,N,N-trimethyl-4-oxo-, inner salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed under GLP and in accordance with OECD-/EU-testing guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Sponsor's identification: P5476
- Date received: 26-Oct-1993
- Description: colourless liquid
- Container: clear glass jar
- Storage conditions: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.32-2.37 kg
- Acclimation: 5 days
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C
- Humidity (%): 50-58%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours darkness; 12 hours continuous light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

the substance was used as such (40% aqueous solution)

Controls:

no

Amount / concentration applied:

A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 hours

Number of animals:

3 male rabbits

Details on study design:

On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the from Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Max. score:

0

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Max. score:

0

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

There were neither corrosive nor irritant skin responses observed.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information the aqueous solution does not have any classification/labelling requirements; for the concentrated test material there are no test results available, therefore a final classification for this quality can not be made. Criteria used for interpretation of results: EU

Conclusions:

The aqueous solution was found to be non-irritating to the rabbit skin; for the concentrated test material there are no test data available.

Executive summary:

The test was performed 1993 under GLP according to the EU standard testing method B.4 (Directive 67/548/EEC). The study was performed on 3 male rabbits. 0.5 ml test item solution was applied semi-occlusively on the clipped skin area of the test animals. There were neither mortality, clinical symptoms nor skin reactions observed.