Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
methyl 1-(3-chloropyridin-2-yl)-3-(hydroxymethyl)-1H-pyrazole-5-carboxylate
EC Number:
937-132-1
Cas Number:
960316-73-8
Molecular formula:
C11H10ClN3O3
IUPAC Name:
methyl 1-(3-chloropyridin-2-yl)-3-(hydroxymethyl)-1H-pyrazole-5-carboxylate

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: DMF 25 and 50% (w/v)
Concentration:
Topical application: 10, 25 and 50% (w/v) in DMF
No. of animals per dose:
test group: 5 animals
control group: 5 animals

Results and discussion

In vivo (LLNA)

Results
Key result
Remarks on result:
other: not sensitising
Remarks:
not sensitising

Any other information on results incl. tables

Table 1: Summary of results of the LLNA

Concentration (% in w/v) in DMF

dpm/node

Stimulation index

Result

Vehicle (DMF)

78.2

1.0

Negative

10

69.8

0.9

Negative

25

60.5

0.8

Negative

50

135.4

1.7

Negative

Positive control (25% HCA in DMF)

1628.6

20.8**

Positive

NA: not applicable

dpm: disintegrations per minute

**: significant (p<0.01, Mann-Whitney U-test versus negative control)

HCA: α-Hexylcinnamaldehyde

Applicant's summary and conclusion

Interpretation of results:
not 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. No treatment related effects were observed on animal body weights in any test item treated group as well as in the negative and positive control groups. The calculated stimulation index values were under the threshold limit of 3 observed at three examined concentrations indicating that the test material is not a skin sensitizer. The lack of enlarged lymph nodes in the test item treated groups was in good correlation with this conclusion. Furthermore, no statistically significant difference was observed between the measured values of the test item treated groups when compared to the negative (vehicle) control group.