N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

EC Number:

218-915-0

EC Name:

N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

Cas Number:

2280-49-1

Molecular formula:

C13H10Cl3NO2S2

IUPAC Name:

N-phenyl-N-[(trichloromethyl)sulfanyl]benzenesulfonamide

Test material form:

other: solid

Details on test material:

N-Phenyl-N-[(trichloromethyl)thio ]benzenesulphonamide
99.8% (not used for calculation)

In vivo test system

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

Test item: 0 % (vehicle control), 2 %, 10 % and 50 %.
Positive control: 40 % Alpha Hexyl Cinnamic Aldehyde

No. of animals per dose:

The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain HsdWin:NMRI (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item N-Phenyl-N-[(trichloromethyl)thio ]benzenesulphonamide. A concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Not applicable because the modified Local Lymph Node Assay (IMDS) was performed.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Not applicable because the modified Local Lymph Node Assay (IMDS) was performed.

Any other information on results incl. tables

Compared to vehicle treated animals there were clear increases in weights of the draining lymph nodes and in the cell counts at all dose groups. These changes are of statistical significance. The "positive level" of index 1.4 [6, 8, 9] was exceeded for the cell counts in all

dose groups.

The "positive level" of ear swelling which is 2x 10·2 mm increase [8, 9], i.e. about 10% of the control values, has been exceeded in all dose groups (Appendix 11.2.2.). These changes are of statistical significance. A significant increase compared to vehicle treated animals regarding ear weights was detected in all dose groups as well. An increase in these parameters would point to an acute irritating (inflammatory) response. However, such an irritant property could also be combined with a strong skin sensitizing

potential of a test compound.

In conclusion, these results show that the test item N-Phenyl-N[( trichloromethyl)thio]benzenesulphonamide has a strong sensitizing potential in mice after dermal application of a 2 % concentration. Although it is not possible to calculate an exact EC value from the data obtained, it is clear that the EC value is in any case below 1%.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (indication of significant skin sensitising potential) based on GHS criteria

Executive summary:

In conclusion, these results show that the test item N-Phenyl-N[( trichloromethyl)thio]benzenesulphonamide has a strong sensitizing potential in mice after dermal application of a 2 % concentration. Although it is not possible to calculate an exact EC value from the data obtained, it is clear that the EC value is in any case below 1%.