3-((3,4-dicyanophenyl)sulfonyl)-N-(2-hydroxypropyl)propane-1-sulfonamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 01 June 2010 and 29 June 2010. The final report was issued 24 August 2010.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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:

EU Method B.42 (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:

3-((3,4-Dicyanophenyl)sulfonyl)-N-(2-hydroxypropyl)propane-1-sulfonamide

Cas Number:

569316-81-0

Molecular formula:

C14H17N3O5S2

IUPAC Name:

3-((3,4-Dicyanophenyl)sulfonyl)-N-(2-hydroxypropyl)propane-1-sulfonamide

Test material form:

solid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

Female CBA/Ca (CBA/CaOlaHsd) strain mice were used. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.

The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food was allowed throughout the study.

The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

50%, 25% or 10% w/w in dimethylformamide

No. of animals per dose:

4

Details on study design:

Groups of four mice were treated with the test material at concentrations of 50%, 25% or 10% w/w in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 ul of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.

Positive control substance(s):

other: No positive control run during the study. A periodic validation study is run by the test laboratory to check the sensitvity and relability of the test system using alpha-hexylcinnamic aldehyde.

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

0.85

Test group / Remarks:

10% w/w test substance in DMF

Results 2

Key result

Parameter:

SI

Value:

1.09

Test group / Remarks:

25% w/w test substance in DMF

Results 3

Key result

Parameter:

SI

Value:

0.53

Test group / Remarks:

50% w/w test substance in DMF

Any other information on results incl. tables

Preliminary Screening Test

Clinical observations, bodyweight and mortality data were recorded. No signs of systemic toxicity were noted. White residual test material on the ears was noted post dose on Days 1 to 3 and on Days 4 and 5. Based on this information the dose levels selected for the main test were 50%, 25% and 10% w/w in dimethyl formamide.

Main Test

In the main test the radioactive disintegrations per minute per lymph node and the stimulation index were recorded. There were no deaths on the study and no signs of systemic toxicity noted in the test or control animals. White residual test material on the ears was noted, post dose on Days 1 to 3 and on Day 4, in animals treated with the test material at a concentration of 50% w/w in dimethyl formamide. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

Introduction

A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following: OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002) Method 842 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 44012008.

Results

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. White residual test material on the ears was noted, post dose on Days 1 to 3 and on Day 4, in animals treated with the test material at a concentration of 50% w/w in dimethyl formamide.

Conclusion

The test material was considered to be a non-sensitiser under the conditions of the test.