N-methylhyoscinium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February - 03 March 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with an internationally established guideline (OECD, see below).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

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:

Methscopolamine Bromide

IUPAC Name:

Methscopolamine Bromide

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Methscopolamine Bromide
- Physical state:solid
- Analytical purity: 100%
- Purity test date: 19 February 2007
- Lot/batch No.: 1026268
- Expiration date of the lot/batch: September 2009
- Stability under test conditions: yes
- Storage condition of test material: at room temperature, protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
- Age at study initiation: ~ 4 months
- Weight at study initiation: 3.2 kg – 4.2 kg
- Housing: Rabbits were housed individually in solid wire cages. The bottoms of the cages were changed at least once a week and cleaned.
- Diet (e.g. ad libitum): Dry food ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 45 - 75
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 0.5g per application

VEHICLE
- Amount(s) applied (volume or weight with unit): the necessary amount of the test item was mixed with the
smallest amount of demineralised water as vehicle to achieve a paste.

Duration of treatment / exposure:

Rabbit 1: 3 min (area 1); 1 h (area 2); 4 h (area 3)
Rabbit 2&3: 4 h (area 3)

Observation period:

72h

Number of animals:

3

Details on study design:

SCORING SYSTEM:
according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: all aninals (1,2,3)

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: all animals (1, 2, 3)

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Any other information on results incl. tables

There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin alterations beyond the area of exposure. No alterations of the rabbits' general appearance were observed subsequent to local application of the test item. In addition, no skin reaction beyond the area of exposure was observed and application of Methscopolamine Bromide did not result in any effect on body weight development.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Methscopolamine Bromide had no irritating or corrosive effect on rabbit skin subsequent to dermal application.