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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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)

Species:

mouse

Strain:

NMRI

Sex:

female

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.

Parameter:

SI

Remarks on result:

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

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

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

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%.

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%.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

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%.

Justification for selection of skin sensitisation endpoint:
Guideline study according to GLP

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the LLNA study the compound will be labelled Skin Sens 1A according to GHS.