3-Thiophenecarboxylic acid, 4-(isocyanatosulfonyl)-5-methyl-, methyl ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according EU/OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2010)

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 4-(isocyanatosulfonyl)-5-methylthiophene-3-carboxylate

EC Number:

618-297-6

Cas Number:

897671-34-0

Molecular formula:

C8H7NO5S2

IUPAC Name:

methyl 4-(isocyanatosulfonyl)-5-methylthiophene-3-carboxylate

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

Topical application: 25, 50 and 100% (w/v) in acetone/olive oil (4:1 v/v)

No. of animals per dose:

test group: 5 animals
control group: 5 animals

Results and discussion

In vivo (LLNA)

Results

Remarks on result:

other: see results in table 1, any other information on results incl. tables

Remarks:

see results in table 1, any other information on results incl. tables

Any other information on results incl. tables

Table 1: Summary of LLNA results

Concentration (% in w/v) in acetone/olive oil (4:1)	dpm/node	Stimulation index	Result
Vehicle	102.0	1.0	Negative
25	2763.4	27.1**	Positive
50	6236.5	61.1**	Positive
100	4634.0	45.4**	Positive
Positive control	1477.1	14.5**	Positive

** = Significant (p<0.01, Mann-Whitney U-test versus negative control)

dpm = disintegrations per node

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality or systemic toxicity was observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate was observed on the ears of the animals in the 100 and 50% (w/v) dose groups on Days 1-6 and in the 25% (w/v) dose group on Days 2-3. Minimal alopecia was observed on Day 6 in the 100% (w/v) dose group for two animals. No treatment related effects were observed on animal body weights in any test item treated, negative and positive control groups. Appearance of the lymph nodes was normal in the negative control group. The stimulation index values were 45.4, 61.1 and 27.1 at concentrations of 100, 50 and 25 % (w/v), respectively. The resulted stimulation index values above the threshold limit of 3 observed at three examined concentrations indicates that the test material is a skin sensitizer.