Registration Dossier

Diss Factsheets

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:

One study (Longobardi 2002c) is recorded for this endpoint and was chosen as a key study. The delayed contact hypersensitivity of the substance was assessed using the Maximization method of Magnusson and Kligman. This study was conducted in compliance with the principles of Good Laboratory Practices and performed according to the OECD guideline 406.

The induction phase was realized both by intradermal route on day 1 (Test material 0.5 % w/v in sterile water) and by cutaneous route on day 8 (Test material 10% w/v in sterile water ) in 2 groups of guinea pigs: 10 females for control group and 20 females for treated group. The challenge phase was realized on day 22 by cutaneous application of the test material at 10% w/v in sterile water. The cutaneous reactions were scored 24 and 48 after the challenge phase. As a response to treatment was noted in a number of animals in both the control and test groups, a re-challenge at the lower concentration of 1% was performed on day 29.

The first challenge application with 10% w/v of the test material in sterile water resulted in very slight to well defined erythema in the majority of animals of both test and control groups (6/10 and 13/20 at the 48-hour reading respectively). No reaction was noted to the vehicle alone. The presence of reaction in both test and control group animals indicated an irritant response to treatment rather than sensitisation. This was investigated by repeating the challenge with a lower concentration of 1% one week later. On this occasion, no response was observed in any animal of the test or control groups following 24 hours topical exposure. Again, no reaction to the vehicle alone was observed.

It was concluded that the substance does not elicit a sensitisation response in the guinea pig.


Migrated from Short description of key information:
The potential of the substance to induce delayed contact hypersensitivity was investigated using the Maximization method of Magnusson and Kligman(OECD 406, GLP) . The test item was found to be non-sensitising.

Respiratory sensitisation

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

There is no information on respiratory sensitisation. However, no concerns are expected. The molecular structure of quaternary ammonium compound BDHTMAC does not contain toxicophore indicating a concern for sensitisation and the likelihood for exposure via inhalation is very low based on the high boiling point and very low vapour pressure of the substance. Also structurally similar substance DHTDMAC to has shown no sensitising properties in testing for dermal sensitisation. As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non respiratory sensitisation of the substance.


Migrated from Short description of key information:
No information. No respiratory sensitisation is expected.

Justification for classification or non-classification

Based on limited exposures by dermal route (substance is very corrosive) or by inhalation (very low vapour pressure) and results from a structurally related dialkyl quat showing no sensitisation, as well as lack of toxicophores in the structure of BDHTMAC indicating a concern for sensitisation, there are no concerns for sensitisation expected.

Categories Display