cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-02-02 to 2004-02-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 595.12

Deviations:

no

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme but no formal claim of GLP compliance is made for this study.

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol

EC Number:

267-747-4

EC Name:

cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol

Cas Number:

67914-85-6

Molecular formula:

C13H13Cl2N3O3

IUPAC Name:

(+-)-cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): JNJ-16466970-AAA (T001207)
- Physical state: solid
- Appearance: white powder

Specific details on test material used for the study:

no data

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

no data

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

2.5, 5 and 10% (w/w) in dimethylformamide

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Lymph node proliferation response: no data
- Systemic toxicity: A preliminary sighting test was conducted in which there were no signs of systemic toxicity at a concentration of 10% w/w in dimethylformamide. A further group of four animals was treated with dimethylformamide alone.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay.
- Criteria used to consider a positive response: stimulation index: Test to control ratio greater than 3.0 indicates a 'positive' result.

TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals were treated with 50 uL of the test substance (25 uL per ear) as a solution in dimethylformamide.

Positive control substance(s):

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

other: 2,4-dinitrobenzenesulfonic acid, sodium salt 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water

Statistics:

no data

Results and discussion

Positive control results:

See Any other information on results incl. tables

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.76

Test group / Remarks:

2.5% w/w group

Results 2

Parameter:

SI

Value:

1.45

Test group / Remarks:

5% w/w group

Results 3

Parameter:

SI

Value:

1.67

Test group / Remarks:

10% w/w group

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA
no data

DETAILS ON STIMULATION INDEX CALCULATION
see Results table

EC3 CALCULATION
No SI value = or > 3 was observed

CLINICAL OBSERVATIONS:
no data

BODY WEIGHTS
no data

Any other information on results incl. tables

Positive Control Local Lymph Node Assay in the Mouse (2004)

Project Number	Start Date	Finish Date	Test Material	Concentration	Vehicle	Stimulation Index^a	Classification^b
039/687·	29/04/2004	05/05/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	acetone/olive oil 4:1	1.40, 2.23, 6.09	Positive
039/688*	29/04/2004	05/05/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	acetone/olive oil 4:1	1.74, 2.20, 8.89	Positive
039/719*	14/10/2004	26/10/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	tetrahydrofuran	1.97, 3.71, 7.82	Positive
039/720*	29/09/2004	05/10/2004	2,4‑Dinitrobenzenesulfonic acid, sodium salt	1%, 10%, 20% v/v	1% pluronic F-68 in distilled water	1.03, 4.41, 13.55	Positive
039/723*	27/10/2004	02/11/2004	α‑Hexylcinnamaldehyde, tech., 85%	10%, 25%, 50% v/v	cottonseed oil	1.52, 2.63, 5.07	Positive

a=         Ratio of test to control lymphocyte proliferation

b=         Stimulation index greater than 3.0 indicates a positive result

* =         Standard Test Method 595 (Pooled nodes)

·=          Standard Test Method 599 (Individual nodes)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be a non-sensitizer under the conditions of the test.