4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-08-03 to 2011-09-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

EC Number:

247-501-2

EC Name:

4-amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide

Cas Number:

26175-68-8

Molecular formula:

C8H10Cl2N2O2S

IUPAC Name:

4-amino-2,5-dichloro-N,N-dimethylbenzene-1-sulfonamide

Details on test material:

- Name of test material (as cited in study report): 4-Amino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Winke1mann, 33178 Barchen, Germany
- Age at study initiation: 8 -9 weeks
- Weight at study initiation: 18 - 22 g
- Housing: Full barrier in an air-conditioned room, in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Adequate acclimatisation period (at least five days)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

8.25%, 16.5%, 33%

No. of animals per dose:

5

Details on study design:

A solubility test was performed to determine the highest applicable concentration.
A preliminary test was performed to determine the highest tolerated and non-irritant test concentration.

Positive control substance(s):

other: p-Phenylenediamine

Statistics:

EC3=c+[(3-d)/(b-d)]x(a-c)

Results and discussion

Positive control results:

p-Phenylenediamine (1 %) S.I.: 13.4

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: negative control: 1.0 08.25 %: 1.6 16.50 %: 1.4 33.00 %: 1.1

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: negative control: 1185 08.25 %: 1887 16.50 %: 1672 33.00 %: 1330

Any other information on results incl. tables

None of the three tested concentrations of the test item caused a stimulation index equal or greater than 3.

All animals survived throughout the test period without showing any clinical signs. All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the outcome of this study the test item 4-Arnino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.

Executive summary:

SUMMARY

 

Based on the results of the preliminary test the test item was assessed for sensitizing properties at concentrations of 8.25%, 16.5% and 33% (each suspended in AOO 4:1, v/v) according to OECD 429.

 

At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed.

 

Species/strain:           Mice, CBA/CaOlaHsd

 

Number of animals:    20/main test

 

Vehicle:                      AOO (4: I (v/v) acetone/olive oil)

 

 

Summary Results

 

None of the three tested concentrations of the test item caused a stimulation index equal or greater than 3

 

The stimulation index at a concentration          of        08.25 % was 1.6

 

The stimulation index at a concentration          of        16.50 % was 1.4

 

The stimulation index at a concentration          of        33.00 % was 1.1

 

 

Conclusion

 

The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.

 

Consequently, according to OECD 429 the test item 4-Arnino-2,5-dichloro-N,N-dimethylbenzenesulphonamide, trocken, as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.