3-({[(4-methylphenyl)sulfonyl]carbamoyl}amino)phenyl 4-methylbenzenesulfonate;N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD-guideline and GLP-compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-520-2

EC Name:

-

Cas Number:

232938-43-1

Molecular formula:

C21 H20 N2 O6 S2

IUPAC Name:

3-{[(4-methylbenzenesulfonyl)carbamoyl]amino}phenyl 4-methylbenzene-1-sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain as stated in the report: Hanlbm: WIST (SPF)
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding. During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 3433 rat maintenance diet, ad libitum
- Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±3°C
- Humidity (%):40-70% (values above 70% during cleaning process possible).
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10 % of the total body surface

REMOVAL OF TEST SUBSTANCE
- Washing: 24 h after application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels

TEST MATERIAL
- Amount applied: 4.0 ml/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times on first day, afterwards once daily
- Frequency of weighing: On first day, day 8 and day 15
- Necropsy of survivors performed: yes, all animals were sacrified and subjected to gross pathology

Statistics:

No statistical analysis was used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the treated animals died. No clinical signs were observed.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Body weight of male and female rats after dermal treatment with 2000 mg/kg bw of test article

Body weight in grams:
Sex	Animal No.	Day of treatment	Day 8	Day 15
Male	1	235.8	259.5	281.6
	2	235.1	252.8	269.6
	3	231.3	258.2	279.8
	4	247.3	277.4	300.5
	5	240.1	262.1	278.6
female	6	201.4	207.7	216.2
	7	223.5	230.0	227.4
	8	207.9	226.7	228.9
	9	199.1	203.3	212.0
	10	205.7	207.5	223.4

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After dermal application of 2000 mg/kg bw test article to female and male rats for 24 h under semi-occlusive conditions according to OECD 402 (1987) no mortality was observed. Thus, the LD50 was above 2000 mg/kg bw for both sexes.