Dialkylheteromonocyclium alkanoate

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Test material form:

other: liquid

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/J, inbred, SPF quality

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 11 weeks old
- Weight at study initiation: 20-25 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

pre-screen test: 2.5, 5, 10, 25, 50 and 100%
main study: 1, 2.5 and 5%
control animals: vehicle alone (Dimethyl formamide)

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
- Irritation: down to 10%
- Lymph node proliferation response: down to 25%

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Individual nodes
- Criteria used to consider a positive response: SI ≥3

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

The SI values calculated for the substance concentrations 1, 2.5 and 5% were 1.3, 2.3 and 2.5, respectively. Since there was no indication that the test substance elicits an SI ≥ 3 when tested up to 5%, 1,3-Dimethyl-1H-imidazol-3-ium propanoate was considered not to be a skin sensitizer.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 1, 2.5 and 5% were 742, 1280 and 1361 DPM respectively. The mean DPM/animal value for the vehicle control group was 553 DPM.

Any other information on results incl. tables

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Based on these results, the substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.