cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride

Endpoint summary

Description of key information

Skin sensitisation:

In a K2 LLNA study performed according to SPL Standard Test Method 595.12, the test item was considered to be a non-sensitiser under the conditions of the test (Sanders, 2004).

Respiratory sensitisation

No reliable respiratory sensitisation study was available

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-27 to 2004-02-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 595.12

Deviations:

no

GLP compliance:

no

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Vehicle:

dimethylformamide

Concentration:

2.5, 5 and 10% (w/w) in dimethylformamide (suspension)
A further group of four animals was treated with dimethyl formamide alone.

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Systemic toxicity: no signs of systemic toxicity at a concentration of 10% w/w
- Ear thickness measurements: no data
- Erythema scores: no data

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


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

Positive control substance(s):

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

other: 2,4 Dinitrobenzenesulfonic acid, sodium salt at 1%, 10%, 20% in 1% pluronic F-68 in distilled water

Parameter:

SI

Value:

1.33

Test group / Remarks:

2.5% w/w group

Parameter:

SI

Value:

1.51

Test group / Remarks:

5% w/w group

Parameter:

SI

Value:

1.38

Test group / Remarks:

10% w/w group

Cellular proliferation data / Observations:

SI values see results. No further data reported.

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

Start Date	Finish Date	Test Material	Concentration	Vehicle	Stimulation Index^a	Classification^b
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
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
14/10/2004	26/10/2004	α‑Hexylcinnamaldehyde, tech., 85%	5%, 10%, 25% v/v	tetrahydrofuran	1.97, 3.71, 7.82	Positive
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
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)

Interpretation of results:

GHS criteria not met

Conclusions:

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

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A local lymph node assay (LLNA) was performed to assess the skin sensitisation potential of T001202 in the CBA/Ca strain of mouse.

Following a preliminary sighting test at which there were no signs of systemic toxicity at a concentration of 10% w/w, three groups, each of four animals, were treated with 50 µl of the test material (25 µl per ear) as a suspension in dimethyl formamide at concentrations of 2.5%, 5% or 10% w/w. A further group of four animals was treated with dimethyl formamide alone. The stimulation index expressed as mean radioactive incorporation for eah treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows: 1.33 (2.5% w/w group), 1.51 (5% w/w group) and 1.38 (10% w/w group). The test material was considered to be a non-sensitiser under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin sensitisation:

Based on the available data and the criteria of the CLP Regulation, T001202 should not be classified as skin sensitiser.

Respiratory sensitisation:

No data were available to decide on the classification for respiratory sensitisation.