1,2-Benzenediol, 4-[(4-methylphenyl)sulfonyl]-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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

Principles of method if other than guideline:

No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

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:

4-(p-tolylsulfonyl)benzene-1,2-diol

Cas Number:

107065-85-0

Molecular formula:

C13H12O4S

IUPAC Name:

4-(p-tolylsulfonyl)benzene-1,2-diol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

The animals were nulliparous and non pregnant. After an acclimatization perios of at least five days the animals were selected at random At the start of the study the animals were in the weight range of 15 to 23g, and were eight to twelve weeks old. The animals were group 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 set to achieve limits of 19 to 25°C and 30 ti 70%, respectively. The rate of air exchange was appr. 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12h 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%, 10%w/w

No. of animals per dose:

4 mice

Details on study design:

PRELIMINARY SCREENING TEST: the mouse was treated daily with 25 microL of test item at 50%w/w, to the ear for 3 days (days 1. 2. 3). The mouse was observed for 6 days. Thickness of each ear was measured.

MAIN STUDY
groups of 4 mice were treated for 3 days by applicaion of 25 microL to the dorsal surface of each ear.

Statistics:

/

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: vehicle only: 11983.42 10%w/w: 42349.52 25%w/w: 38475.86 50%w/w: 30307.84

Results 2

Parameter:

SI

Value:

3.53

Test group / Remarks:

10% w/w

Results 3

Parameter:

SI

Value:

3.21

Test group / Remarks:

25% w/w

Results 4

Parameter:

SI

Value:

2.53

Test group / Remarks:

50% w/w

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test item was considered to be a sensitizer under the conditions of the test.