Benzoic acid, 2-[[(4-hydroxyphenyl)sulfonyl]oxy]-, methyl ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23-29 November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data have been generated according to current internationally recognised study guidelines and in accordance with 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)

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:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Cas Number:

1432505-97-9

Molecular formula:

C14H12O6S

IUPAC Name:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

50, 25 and 10 (w/v)%

No. of animals per dose:

4

Details on study design:

The Preliminary Irritation / Toxicity Test was performed in CBA/J Rj mice using two doses: 50 and 25 (w/v) % in the selected vehicle. The observations recorded in the preliminary test suggested that these doses are suitable for a valid LLNA.

In the main assay, twenty female CBA/J Rj mice were allocated to five groups of four animals each:
- three groups received JKY-270 (formulated in DMF) at 50, 25 and 10 (w/v)% concentrations,
- the negative control group received the vehicle (DMF),
- the positive control group received 25 (w/v) % HCA (dissolved in DMF).

Positive control substance(s):

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

Results and discussion

Positive control results:

Larger than normal lymph nodes were observed in the positive control group. The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in the same vehicle was used to demonstrate the appropriate performance of the assay. The positive control produced a DPM of 14142.0 and a stimulation index of 14.2.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 50 (w/v) % in DMF: 1.2 25 (w/v) % in DMF: 0.9 10 (w/v) % in DMF: 0.8 Negative (vehicle) control (DMF): 1.0

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 50 (w/v) % in DMF: 1160.0 25 (w/v) % in DMF: 920.0 10 (w/v) % in DMF: 828 Negative (vehicle) control (DMF): 1051

Any other information on results incl. tables

The test item was a powder, which was formulated in N,N-Dimethylformamide. Since, there were no confounding effects of irritation or systemic toxicity at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test item to cause lymphoproliferation in the Local Lymph Node Assay. The resulted stimulation indexes observed under these exaggerated test conditions was considered to be good evidence that JKY-270 is a non-sensitizer

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test in a suitable vehicle, the test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay

Executive summary:

The sensitising potential has been assessed by topical application to the female mice in a suitable vehicle (DMF) with a concurrent positive (HCA, 25% w/v in DMF) and solvent control in accordance with the OECD 429 test guideline in compliance with GLP. Under the conditions of the test in a suitable vehicle, the test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay