Methanaminium, N,N,N-trimethyl-, 2,2-dimethylpropanoate (1:1)

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

-

EC Number:

478-310-4

EC Name:

-

Cas Number:

53803-13-7

Molecular formula:

C9H21NO2

IUPAC Name:

Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid

Test material form:

solid: crystalline

Details on test material:

Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid,Batch 13AP016, expiry date 13.11.2015

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: ethanol/distilled water 7:3

Concentration:

5% - 10% - 25%

No. of animals per dose:

4

Details on study design:

Following a preliminary screening test in which clinical signs of toxicity were noted at a concentration of 50% w/w but not at a concentration of 25% w/w, 25% w/w was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 ul. (25 ul. per ear) of the test item as a solution in ethanol/distilled water 7:3 at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with ethanol/distilled water 7:3 alone.

Positive control substance(s):

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

Results and discussion

Positive control results:

Stimulation index for positive control substance was 18.54 so substance is considered sensitizer

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Concentration 5% - 1.3 Concentration 10% - 2.03 Concentration 25% - terminated due to toxicity

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See attached table 4

Results 3

Parameter:

SI

Value:

1.3

Test group / Remarks:

5% w/w Concentration in ethanol/distilled water 7:3

Results 4

Parameter:

SI

Value:

2.03

Test group / Remarks:

10% w/w/ concentration in ethanol/distilled water 7:3

Any other information on results incl. tables

In the group treated with the test item at a concentration of 25% w/w in ethanol/distilled water 7:3, one animal was found dead and one animal developed signs of toxicity and was humanely killed on Day 3. The other two animals within the group were killed humanely as there were not enough animals remaining in the group to provide a result. No deaths or signs of systemic toxicity were noted in the remaining test or control animals during the test.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.

Executive summary:

Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.