Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

EC Number:

281-719-9

EC Name:

Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Cas Number:

84029-45-8

Molecular formula:

C14H12N2O6S.Na

IUPAC Name:

sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate

Details on test material:

Purity: 91.0 % (wlw)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B. V., Postbus 6174, NL - 5960 AD Horst 1The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:group
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after
health examination. Only animals without any visible signs of illness will be used for the study

ENVIRONMENTAL CONDITIONS
- Temperature ("C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark 1 hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

5, 10, and 20%

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

The test with alpha-Hexylcinnamaldehyde in DMSO yielded in EC3 value of 7.8

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see above

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Test item Measurement Calculation concentration Group DPM DPM - BG number of DPM per Result % lymph nodes lymph node S. I. --- BG I 25 --- --- --- --- --- BG II 39 --- --- --- --- --- 1 4205 4173 8 521.6 5 2 5962 5930 8 741.3 1.42 10 3 4105 4073 8 509.1 0.98 20 4 6741 6709 8 838.6 1.61 BG=Background (1 ml 5% trichloroacetic acid) in duplicate

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item Nitrotolylsulfanilsäure, Natriumsalz TF was not a skin sensitiser under the described conditions.

Executive summary:

In order to study a possible contact allergenic potential of Nitrotolylsulfanilsäure, Natriumsalz TF, three groups each of four female mice were treated daily with the test item at concentrations of 5, 10, and 20% (w/v) in dimethylsulfoxide by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (dimethylsulfoxide) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter.

All treated animals survived the scheduled study period and no signs of toxicity were observed. A relevant increase in ear weights (punches) was not observed and a statistically signifigance of the ear weight was not determined.

A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.

In this study Stimulation Indices of 1.42, 0.98, and 1.61 were determined with the test item at concentrations of 5, 10, and 20% in dimethylsulfoxide.

The EC3 value could not be calculated, since all obtained SI´s were below 3.