Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 Nov - 05 Nov 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24 Apr 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 28 Jul 2015

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-320-2

EC Name:

-

Cas Number:

221667-31-8

Molecular formula:

C18H18N205S

IUPAC Name:

N-[4-(cyclopropylcarbamoyl)benzenesulfonyl]-2-methoxybenzamide

Test animals

Species:

rabbit

Strain:

other: Crl:KBL(NZW)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany
- Age at study initiation: Young adults (actual ages not stated)
- Weight at study initiation: 2.9 kg - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding.
- Diet: Standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, Soest, Germany), approx. 100 g/animal/day, ad libitum.
- Water: Tap water from polycarbonate bottles, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 2004-11-02 To 2004-11-05

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

The pulverized test substance was moistened with Aqua p.i. to ensure good contact with the skin.

Controls:

other: untreated dorsolateral skin site of same animal served as control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

Initial test (1 animal): 3 min, 1 and 4 h.
Confrimatory test (2 animals): 4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h after patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 on the dorsal area of the trunk.
- Type of wrap if used: Gauze patch held in place with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, skin was carefully washed with water.
- Time after start of exposure: Initial test 3 min, 1 and 4 h. Confrimatory test 4 h.

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 h after patch removal.

SCORING SYSTEM:
- Method of calculation: Draize scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No evidence of skin irritation was observed

Other effects:

No treatment-related signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.