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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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)

Species:

mouse

Strain:

CBA

Sex:

female

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)

Positive control results:

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

Parameter:

SI

Remarks on result:

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

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See attached table 4

Parameter:

SI

Value:

1.3

Test group / Remarks:

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

Parameter:

SI

Value:

2.03

Test group / Remarks:

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is considered to be non-sensitizer under the consitions of LLNA study.