Benzoxazole, 5-chloro-2-[(5R)-hexahydro-5-methyl-1H-1,4-diazepin-1-yl]-, hydrochloride (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:

guideline study

Remarks:

In accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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:

(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-ium chloride

EC Number:

690-742-7

Cas Number:

1266664-66-7

Molecular formula:

C13H17Cl2N3O

IUPAC Name:

(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-ium chloride

Details on test material:

Purity > 98 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., PA, USA.
- Age at study initiation: ca 4.5 months.
- Weight at study initiation: 2.8 - 3.2 kg.
- Housing: 1/sex/cage.
- Diet (e.g. ad libitum): PMI Rabbit Chow, ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled, but not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12-hours light/dark.
IN-LIFE DATES: From: March 24, 2009 To: March 27, 2009

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g / site.
- Concentration (if solution): Moistened with 0.2 mL distilled water to form a paste.

Duration of treatment / exposure:

Single application.

Observation period:

72 Hours

Number of animals:

3 females.

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (6.25 cm2)
- % coverage: ca 10%
- Type of wrap if used: Gauze patch, under porous (semi-occlusive) dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Erythema and edema were scored according to the numerical Draize Scale. The skin was also evaluated for ulceration, necrosis and evidence of tissue destruction.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: All

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

Erythema or edema were not evident at 60 minutes, or at 24, 48 and 72 hours after patch removal.

Other effects:

There were no adverse clinical findings or effects on body weight.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.

Executive summary:

The test article was applied to the un-abraded skin of 3 female New Zealand White rabbits under a semi-occlusive dressing. The test article was applied at 0.5 g / site and was moistened with 0.2 mL of distilled water to form a paste. The test article was kept in contact with the skin for 4 hours. Residual test article was removed with distilled water prior to scoring. Test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours following patch removal (Draize scale).

Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.