4-(oxiran-2-ylmethoxy)-9H-carbazole

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-[(oxiran-2-yl)methoxy]-9H-carbazole

EC Number:

610-764-2

Cas Number:

51997-51-4

Molecular formula:

C15H13NO2

IUPAC Name:

4-[(oxiran-2-yl)methoxy]-9H-carbazole

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Carvedilol 4th intermediate (OMECOL = Oxiranylmethoxy carbazol)
- Physical state: chamois powder
- Lot/batch No.: 2000/2
- Expiration date of the lot/batch: 02. 2002
- Storage condition of test material: dry, cool place, protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Ferenc Sándor, address: Vörös Hadsereg street 131, Kartal, H-2173, Hungary
- Age at study initiation: adult
- Weight at study initiation: 3012-3428 g at the beginning of the study
3304-3693 g at the end of the study
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, PURISTAR standard diet for rabbits (produced by AGRIBRANDS Europe)
- Water (e.g. ad libitum): ad libitum, tap water (for human consumption) from automatic self supplying watering system
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12-12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of each animal served as control

Amount / concentration applied:

TEST MATERIAL
0.5 g of Carvedilol 4th intermediate was applied to the test site in pure state in a single dose.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (examinations after the patch removal at 1, 24, 48, 72 hours )

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: sterile gauze patch held loosely in place by adhesive but not irritating type

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the treatment perion the rest of the test item was removed with body temperature water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize (1959)
Classification of the test item: according to directive 2001/59/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Time point:

other: 1, 24, 48, 72 hours after the treatment

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Time point:

other: 1, 24, 48, 72 hours after the treatment

Score:

0

Max. score:

0

Irritant / corrosive response data:

No primary irritation symptoms, like erythema and oedema, or other signs occured during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results of present study the test item CARVEDILOL 4th INTERMEDIATE is NON IRRITANT.