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EC number: 263-038-9 | CAS number: 61789-18-2
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Vapour pressure:
- 0.006 Pa
- at the temperature of:
- 25 °C
Under the study conditions, the vapour pressure was determined to be <0.0015 Pa (i.e., equivalent to <1.1 x 10E-5 mm Hg) at 20°C and <0.0058 Pa (i.e., equivalent to <4.3 x 10E-5 mm Hg) at 25°C.
The vapour pressure was determined using the effusion method (isothermal thermogravimetry) according to OECD Guideline 104 and EU Method A.4 and/or EPA OPPTS 830.7950 (Brekelmans, 2012).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Physical state at 20°C and 1013 hPa:
- solid
- Form:
- solid: compact
- Colour:
- white
- Colour intensity:
- light
The substance is a waxy oyster-white solid with a tendency to form clumps, and has a soapy odour at 20 ºC temperature
The appearance and physical state were characterised according to EPA OPPTS 830.6303 (Bodsch, 2008).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Toxic effect type:
- concentration-driven
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 40.3 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Guideline compliant or similar to guideline compliant studies with the test and read across substances
- Endpoint conclusion:
- no study available
- Endpoint conclusion:
- no study available
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- Due to some deficiencies in the study, the 90-day oral study has been considered further for hazard and risk assessment.
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- The test substance has been classified as corrosive (no threshold derived)
Overall, considering the repeated dose studies with the test substance and read across substance (C16 TMAB and C16 TMAC) the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance.
Oral:
Study 1:
A study was conducted to determine the oral repeated dose toxicity of the read across substance, C16 TMAC (24 -26% active in water), according to a method similar to OECD Guideline 407, in compliance with GLP. Groups of 10 male and female rats were administered 0, 30, 100 and 300 mg/kg bw/day of read across substance by oral gavage for 28 days. The read across substance used was a 24-26% aqueous solution but it is not clear if the doses mentioned were corrected. There were no treatment-related changes at the 30 and 100 mg/kg bw/day. In the high-dose group there was an increase in water consumption, changes in the absolute and relative weights of the adrenals and spleens (in males) without corresponding effects on haematology, clinical chemistry and histology. The forestomach of the high-dose group showed few microscopic changes, however animals in the high-dose recovery group showed a complete and regular regeneration of the forestomach mucosa. Hence, the forestomach effects were considered to be due to the irritating properties of the read across substance rather than symptoms of systemic toxicity. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be at 100 mg/kg bw/day, which is corrected to 25 mg a.i./kg bw/day (assuming its not been done in the study report) (Potokar, 1991). Based on the results of the read across study, similar effects and NOAEL can be expected for the test substance.
Study 2:
A 90-day study was conducted to determine the oral repeated dose toxicity of the test substance, TMAC C (35.5% active in water), according to OECD Guideline 408 and EU Method B.26, in compliance with GLP. Sprague-Dawley rats were administered the test substance at concentrations of 0, 100, 500 or 2000 ppm (i.e., corresponding to 0, 22, 113 and 273 mg/kg bw/dayin males and 0, 25, 121, 297 mg/kg bw/dayin females) in the diet for 90 d.The active ingredient dose equivalent were calculated to be 0, 7.9, 40.3 and 96.9 mg a.i./kg bw/day in males and 8.8, 42.9, 105.3 mg a.i./kg bw/day in females.The highest dose of 2000 ppm was reduced to 1000 ppm from Day 29 onwards due to deterioration in health of the test animals at 2000 ppm. At the highest dose, the treatment-related findings were clinical signs of toxicity, reduced body weight gain and food efficiency, organ weight changes and microscopic changes in the spleen and kidneys. At the mid dose, reduced body weight gain (males) and reduced food consumption, reduced absolute heart weight and higher incidence of haemosiderin accumulation in the kidneys of males was observed. No treatment-related effects were observed at the lowest dose.Based on the results of the study, dietary administration of the test substance to rats for a period of 90 d at levels up to 273 mg/kg bw/day resulted in toxicologically significant effects at the high dose and marginal effects at the next lower dose of 113 mg/kg bw/day (500 ppm). No such effects were demonstrated at the lowest dose of 22 mg/kg bw/day (100 ppm).The changes observed at the mid dose (500 ppm) were considered to be minor, isolated effects associated with the reduced palatability of the test substance and were considered not to represent an adverse health effect.Therefore, based on effects on body weight, food efficiency and clinical signs the study authors established the NOAEL at themid dose level of 500 ppm .Under the study conditions, based on effects on body weight, food efficiency and clinical signs, the NOAEL was established at 500 ppm or 113 mg/kg bw/day (i.e., equivalent to 40.3 mg ai./kg bw/day)(Jones, 2002). The accumulation of haemosiderin in the spleen and kidneys at high and mid doses can be considered questionable for their toxicological relevance as they were not associated with any signs of bleeding (black faeces, increased spleen weight, accelerated erythropoiesis) and occurred in the absence of any effects on haematological parameters. Also, their levels in the males remained below the levels in female, whereas typically there is no known difference between the sex of animals for this effect. Further, the reduction in body weight and body weight gain, was attributed to local gastrointestinal irritation/corrosion and consequent reduced food intake without observing any primary systemic effect.
As per the Biocides assessment report on TMAC C, which was published by the Italian authorities in April 2016, the NOAEL in the above study was reported to be at the lowest dose 100 ppm (i.e.,corresponding to 22 mg/kg bw/day or 7.9 mg a.i./kg bw/day). This was based on reduced food consumption with consequent lower body weight gains over the study period (10%) and the occurrence of haemosiderine in kidneys a dose-dependence effect that was considered to be treatment-related at LOAEL (500 ppm). Only at levels when serious differences in body weight were more than 20% compared to the control, other clinical effects occured. Similar results were obtained from subchronic feeding studies with other read across substances didecyldimethylammonium chloride (DDAC; CAS:7173-51-5) (NO(A)EL=42 mg/kg bw/day) and C12-16 ADBAC (NOAEL of 68 mg a.s./kg bw/day) in rats,where the critical effect upon oral exposures were decreased body weight gain. Results from 90-day dog studies with read across substances DDAC and C12-16 ADBAC, with corresponding NOAELs at 15 and 45 mg a.i./kg bw/day (i.e., 486 and 1250 ppm), do not indicate species differences towards mechanism of toxicity by quaternary ammonium compounds. Further, the two highest doses (10 and 20 mg/kg bw/day) in a 1-year oral gavage study in dogs for DDACresulted in g.i.-related complications including emesis and abnormal faeces, resulting in death of 2 out of 4 animals at 20 mg/kg bw/day. The irritation/corrosive properties linked clinical signs observed in all the animals treated at 10 mg/kg bw/day (emesis, salivation, soft/loose faeces) persisted for the entire study duration. Only small amounts of the test substance were considered to be systemically available without giving rise to any significant systemic effect except for 10-15% decrease in body weight, which were considered to be secondary to effects in the gut. The NOAEL for local effects on gut mucosa was fixed equal to 3 mg/kg bw/day,whereas the systemic NOAEL was at 10 mg/kg/day for DDAC. Based on the outcome of the effect assessment, it was concluded that the AEL cannot be regarded as a “true” systemic threshold and therefore AEL approach based risk assessment should not to be performed. Consequently only a semiquantitative local risk assessment was considered for the active substance (ECHA biocides assessment report, 2016).
Study 3:
A 1-year study was conducted to determine repeated dose toxicity of the read across substance, C16 TMAB (99% active) in rats. Read across substance was given to the male and female Sprague-Dawley rats in the drinking water at concentrations of 0.007, 0.014 and 0.032 % i.e., equivalent to 10, 20 and 45 mg/kg bw/day. Male and female rats of the high dose groups showed a significantly reduced body weight development, decreased efficiency of food consumption, decreased skeletal growth. In both males and females, an increased relative caecum weight was found in the high (males and females) and mid (males only) dose groups. No compound related changes were observed in haematological and clinical-chemical analyses of blood and urine. No gross necropsy changes were seen, and no microscopic alterations were found in the wall of stomach and small intestine of treated rats. No other tissues were histopathologically examined. The effects on growth and body weight development observed in the study are considered to be an indirect effect of the administration of read across substance in the drinking water. Since the read across substance caused diarrhoea which resulted in a faster passage of food through the gastrointestinal tract and reduced absorption of nutrients. The increased relative caecum weight may be due to proliferation of the endothelial cell layer caused by an increased replacement rate due to a faster flux of the intestinal contents. This explanation is supported by the lack of histopathologic alterations of the small intestine. Under the study conditions, the NOAEL for the read across substance was considered to be 45 mg/kg bw/day and NOEL for the read across substance was considered to be 10 mg/kg bw/day (Isomma, 1976).Based on the results of the read across study, similar effects and NOAEL can be expected for the test substance.
Overall, considering the repeated dose studies with TMAC C or read across substances as mentioned in the Biocides assessment report, the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances (ECHA biocides assessment report, 2016). Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance.
Dermal
A 28-day study was conducted to determine the repeated dose dermal toxicity of the read across substance, C16 TMAC (54.5% active in aqueous isopropanol), in New Zealand albino rabbits (both sexes) according to a method similar to OECD Guideline 410. The purity was not specified and the study included a lower than recommended number of animals (i.e., 10/group rather than 20/group as per guideline) and histopathology was performed only on limited organs. The read across substance (0 and 10 mg/kg bw/day) was applied to the shaved, intact skin of groups of 5 New Zealand albino rabbits/sex/group for 6.5 to 7 h, 5 days/week for 4 weeks. Dermal irritation readings were recorded daily. The animals were weighed weekly during the exposure period. Blood was collected for haematology measurements before initiation of dosing and prior to termination. Liver and kidneys weights were recorded at necropsy and limited histopathology was conducted. There were no systemic treatment-related effects on body weights, haematology, organ weights, gross necropsy findings or histopathology. Treated areas of the skin showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. Under the study conditions, the 28d NOAEL for male and female rabbits were determined to be 10 mg/kg bw/day (TRS-HPV, 2001). Based on the results of the read across study, similar absence of systemic effects can be expected for the test substance.
Inhalation
The substance has a low vapour pressure (VP = <5.8E-3 Pa at 25°C), which is below the cut-off of 0.01 Pa set for defining low volatility substances, as per the ECHA Guidance R.7a. Therefore, due to its paste like or creamy physical state and low VP, the test substance is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e.g., spraying, elevated temperature/pressure), appropriate risk management measures (due to corrosive nature of the test substance) such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation. Nevertheless, a qualitative risk assessment has been carried out for this route, due to the corrosive nature of the test substance and the fact that the available repeated dose oral studies with the read across substance did not show any primary systemic effects; all observed effects were attributed to local gastrointestinal irritation/corrosion and consequent reduced food intake.
Based on the results from the test substance and read across oral and dermal repeated dose studies, the test substance does not warrant a classification for STOT RE according to the EU CLP criteria (Regulation 1272/2008/EC).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.