Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 629-705-7 | CAS number: 1228186-15-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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