Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Local lymph node assay (LLNA) is known to cause false-positive result.

Both negative1) and positive2) results are reported on “quaternary ammonium compounds, benzyl-C12-16 -alkyldimethyl, chlorides” in LLNA, but this “quaternary ammonium compound” is reported as negative in Guinea Pig Maximization Test3). The result is different by each test.

The result of LLNA on 3-octadecyloxypropyl -N,N,N-trimethylammonium chloride, which was proceeded for this registration, was positive, but negative result was confirmed in Guinea Pig Maximisation Test (report is submitted also) using equivalent 3-octadecyloxypropyl -N,N,N-trimethylammonium chloride.

Considering all the above-mentioned results, 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride seems to be negative in skin sensitisation.

 

1) D. A. Basketter, et al, Food and Chemical toxicology 36, 327-333 (1998)

2) D. A. Basketter, et al, Food and Chemical toxicology 34, 985-997 (1996)

3) The Murine Local Lymph Nod Assay:A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds, Appendix A-3, NIH Publication No.99-4494

 

 


Migrated from Short description of key information:
There are 2 study ebdpoint records for sensitisation. The test material for both studies is the same as the reference substance.
The key study (guinea pig maximisation test (GPMT), reliability of 1) did not show any evidence of reactions indicative of skin sensitisation to the test material under the test condition. The concentrations used in the study were 10% as induction concentration and 0.5, 0.3, 0.1, 0.05, 0.03 and 0.01% as challenge concentrations. The test material is considered to be a non-sensitiser in this condition and does not meet the criteria for classification according to the EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
However, the supporting study (mouse local lymph node assay (LLNA), realiability of 1) showed that the test material was considered to be a sensitiser under the test condition. The concentrations used in the study were 25%, 10% or 5% w/w. Therefore, the test material is classified as R43 May cause sensitisation by skin contact under Council Directive 67/548/EEC and Category 1 under Regulation (EC) No 1272/2008.
Due to the false-positive result of LLNA reported in other substance, 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride seems to be negative in skin sensitisation.

Justification for classification or non-classification

The result of GPMT is more relevant to be used for the classification and labelling of this endpoint. Therefore, the notified substance is not classified for this endpoint under EU classification system.