N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide

EC Number:

240-722-5

EC Name:

N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide

Cas Number:

16673-34-0

Molecular formula:

C16H17ClN2O4S

IUPAC Name:

5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide

Details on test material:

Batch No.: 2010/8102 F
Chemical Name: 4-[2-(5-chloro-2-methoxybenzamido)-ethyl] benzenesulfonamide
Colour: Almost white or pale yellow
Physical State: Powder
Purity: 99.5%
Expiry Date: October 2014
Storage Conditions: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 - 9 weeks old females: 8 - 9 weeks old
Body weight on the day of administration: males: 236 – 249 g; females: 224 – 232 g.
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare [9] the animals were bred for experimental purposes.

Housing and Feeding Conditions:
- Full barrier in an air-conditioned room
- Temperature: 22 3 °C
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1307)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 08/11/10)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days, for details see Schedule)

The animals were marked for individual identification by tail painting.
Approximately 25 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

cotton seed oil

Details on dermal exposure:

Application
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.

Duration of exposure:

The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
All animals were observed for 14 days after dosing.

Doses:

The test item was applied at a single dose of 2000 mg/kg body weight to each animal.

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: No treatment-related effects were observed.

Any other information on results incl. tables

Signs of toxicity related to dose level used, time of onset and duration: No treatment-related effects were observed.

Effect on organs (related to dose level): No treatment-related effects were observed.

Signs of irritation: No erythema or oedema was observed. Desquamation was observed in 1 of 5 male animals on a single day (day 3 post administration).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single dermal application of the test item Benzenesulfonamide to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity and nor of irritation.
The dermal LD50 was determined to be > 2000 mg Benzenesulfonamide / kg body weight.
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC [6] and according to Annex I of Regulation (EC) 1272/2008 [7] the test item Benzenesulfonamide has no obligatory labelling requirement for percutaneous toxicity.