1H-Pyrazole-5-carboxylic acid, 3-(chloromethyl)-1-(3-chloro-2-pyridinyl)-, 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 3-(chloromethyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxylate

EC Number:

936-879-0

Cas Number:

1247712-63-5

Molecular formula:

C11H9Cl2N3O2

IUPAC Name:

methyl 3-(chloromethyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-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: 10, 25 and 50% (w/v) in acetone/olive oil (4:1 w/v)

No. of animals per dose:

test group: 5 animals
control group: 5 animals

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: see table below

Remarks:

see table below

Remarks on result:

other: see table below

Remarks:

see any other information incl. tables below

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	107.5	1.0	Negative
10	1689.3	15.7	Positive
25	1632.5	15.2	Positive
50	2391.7	22.3	Positive
Positive control	2100.4	19.5	Positive

dpm = disintegrations per minute/node

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality was observed during the study. Slightly rigid ears were observed in the 50 % (w/v) dose group on Days 2-3 after treatment. Test item precipitate was observed in the 50 % (w/v) dose group on Days 1-5 and in the 25 % (w/v) dose group on Days 1-3. No treatment related effects were observed on animal body weights, however marked body weight loss (>5%) was detected for one animal in the 50 % (w/v) dose group and for one animal in the positive control group. The calculated stimulation index values were 22.3, 15.2 and 15.7 at concentrations of 50, 25 and 10% (w/v), respectively. The resulted stimulation index values were above the threshold limit of 3 at each examined concentrations indicating that the test material is a skin sensitizer.