Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 638-747-5 | CAS number: 1228186-17-1
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 417 and in compliance to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 417
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22H48N.Cl
- IUPAC Name:
- N-decyl-N,N-dimethyldecan-1-aminium chloride
- Details on test material:
- - Name of test material (as cited in study report): Arquad 2.10-40
- Physical state: Colourless to pale yellowish liquid
- Analytical purity: 40.5 % Didecyldimethylammonium chloride (CAS No 7173-51-5)
- Composition of test material, percentage of components: 40.2 % of DDAC, amine 0.43 %, Amine HCl 0.39 %,
- Purity test date: Oct. 20, 2004
- Lot/batch No.: WIR03048
- Storage condition of test material: At room temperature
Radiolabelled Material: [Methyl-14C]DDAC
- Physical state: Colourless liquid
- Radiochemical purity (if radiolabelling): 98 % (by HPLC), 99.2 % (by TLC)
- Specific activity (if radiolabelling): 1.11 GBq/mmol; 30.1 mCi/mmol (by gravimetric analysis): 1.22 GBq/mmol; 33 mCi/mmol
- Radioactive concentration: 148 MBq/mL, 4 mCi/mL
- Batch Number: CFQ13640
- Purity test date: Nov. 19, 2003
- Expiration date of radiochemical substance (if radiolabelling):
- Storage condition of test material: -20 °C in the absence of light and air is recommended
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France. Caesarean Obtained, Barrier Sustained-Virus Antibody Free (COBS-VAF®).
- Age at study initiation: 7 wk old; for the bile collection group, animals were around 10 wk (males) 12 wk females).
- Weight at study initiation: 229 g males and 159 g females
- Fasting period before study: Overnight
- Housing: 2 or 3 animals/cage in oral groups and singly in dermal and bile collection group
- Diet (e.g. ad libitum): A04 C pelleted diet ad libitum
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2 °C
- Humidity (%): 50±20%
- Air changes (per hr): 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h light/ 12 h dark
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- 6 hours
- Doses:
- Oral: 50 and 200 mg/kg bw /day;
Dermal: 1.5 and 15 mg/kg bw /day - No. of animals per group:
- 9/sex/dose - Plasma/blood pharmacokinetics (Group 1-5)
5/sex/dose - Excretion balance (Group 6-8)
5/sex/dose bile collection (Group 9) - Control animals:
- yes
- Remarks:
- For the purposes of pre-dose sample analysis, plasma, blood and tissues will be collected from at least one untreated supplementary animal/sex using the above mentioned procedures.
- Details on study design:
- APPLICATION OF DOSE: oral, dermal
VEHICLE
- Justification for use and choice of vehicle (if other than water): water
SAMPLE COLLECTION
- Collection of blood: yes
- Collection of urine and faeces: yes
- Collection of expired air: no
ANALYSIS
- Method type(s) for identification: Radio-HPLC for urine samples, LSC for biological samples - Details on in vitro test system (if applicable):
- n.a.
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- no effects
Percutaneous absorption
- Dose:
- 15 mg
- Parameter:
- percentage
- Absorption:
- ca. 1 %
- Remarks on result:
- other: 72 h
- Remarks:
- No precise quantifiable information can be derived on dermal uptake from this study. Mean plasma and blood radioactivity levels were all below quantifiable limits indicating that dermal absorption was very low
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test material (containing 40.5 % DDAC) has low dermal and oral absorption.
- Executive summary:
An OECD guideline 417study was conducted to investigate the blood and plasma pharmacokinetics, tissue distribution and mass balance of total radioactivity of test material [14C-DDAC] following single dermal administration (at 1.5 and 15 mg/kg, as 6 h exposure over 10% of the body surface) and single (at 50 and 200 mg/kg) and repeated (at 50 mg/kg/d) oral gavage administrations to male and female Sprague-Dawley rats. In addition, the elimination of radioactivity in bile after single oral administration at 50 mg/kg was investigated. Investigations included blood and plasma pharmacokinetics, tissue distribution and mass balance of total radioactivity.
The animals were divided into 9 groups; groups 1 to 5 (each of 9 animals/sex) for plasma/blood pharmacokinetics of radioactivity and tissue distribution, groups 6 to 8 (each of 5 animals/sex) principally for excretion balance and group 9 (4 animals/sex) for bile collection. Animals of groups 1 to 4 and 6 and 7 were treated once with the radiolabelled test item. Animals of groups 5 and 8 were treated once per day for 6 d with the unlabelled test item, followed by a single administration of the radiolabelled test material on Day 7.All oral dosages applied 2.2 MBq/kg for radioactive dose-levels, and 3.7 MBq/kg for dermal applications.
Dermal dosages were applied on clipped skin approx. 10% of the total body surface area, over the interscapular/ upper back region. The animals wore an Elizabethan collar to prevent ingestion of the test item. At the end of the exposure period, the collar was removed and kept with the swabs for analysis. After 6 h, the treated areas were washed using dampened cotton swabs with diluted hand soap followed by two dry swabs to remove all traces of the test material.Blood and plasma sampling were performed as below:
Oral group: 0.5, 1, 2, 4, 8, 24, 48, 72 and 96 h
Dermal group: 3 and 6 (i.e. during the exposure period), 7, 8, 10, 16, 24, 48 and 72 h.
Following the final blood sampling/animal (i.e. at 24, 48 and 72/96 h), each sampled animal was sacrificed by cervical dislocation, under isoflurane anesthesia. The carcass were weighed and the following tissues dissected out and weighed: Adrenals, Gastro intestinal tract (complete), Lymph nodes (mesenteric and mandibular), Brain, Heart, Muscle (right leg adductor), Eyes, Kidneys, Pancreas, Fat (abdominal), Liver, Skin (lower back), Femur (right with marrow), Lungs, Spleen. In addition, for the dermal treated animals, the application site will be dissected out and weighed. Thereafter, the application site and the skin from the lower back will be each stripped completely (using tape) 13 times. No macroscopic examination was performed on the prematurely sacrificed animals or those found dead.
Urine and faeces were collected from the groups 6 to 8 animals for the radioactive treatments at the following times:
- During a period of 24 h before radioactive dosing on Day 1 (Groups 6 and 7), or Day 7 (Group 8),
- and then during the periods 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 h after the radioactive gavage/dermal application
After each collection of faeces, the cages and trays will be carefully rinsed with not more than 20 mL of water (cage wash) (except for last collection; approximately 100 mL will be used).
Following single and/or repeated oral gavage at 50 and 200 m g/kg/d, the plasma and blood radioactivity levels were non-quantifiable indicating a low oral bioavailability. The actual minimal fraction of the oral dose absorbed was 0.93 to 3.16%; this was eliminated rapidly, essentially within a 48-h period. The vast majority of the oral dose was excreted rapidly in the faeces. At the high oral dose-level only, quantifiable levels of radioactivity were found in some central organs at 24 h post- dosing (intestines, liver. kidney) ; otherwise, the vast majority of the dose was confined to the intestines and levels decreased over time. Only 2.57/1.14% (males/females) of the oral dose was eliminated in the bile in a 24-h period. No metabolites or parent drug were found in urine.
Following single dermal application at 1.5 and 15 mg/kg, the plasma and blood radioactivity levels were non-quantifiable at all time-points. For the 1.5 mg/kg group, around 1% and 50% of the dose was eliminated in the urine and faeces, respectively, mostly within a 48 h period. At 24 h post- dosing, most of the radioactivity was in the "stripped" skin (dermis and epidermis) application site (6.07 to 21.6% of the dose) and intestines for both dose- levels, though some radioactivity was in the skin adjacent to the application site (most likely from cross- contamination due to grooming) and minor traces were in the eyes and other organs. At 72/168 h, levels in the application site were 1.06 to 2.82% of the radioactive dose, suggesting the skin acted as a drug reservoir. In the stratum corneum of the application site, the levels of radioactivity were of similar magnitude in the different layers at each time point.
Under the test conditions, the test material (containing 40.5 % DDAC) has low dermal and oral absorption. The actual minimal fraction of the oral dose absorbed was 0.93 to 3.16 %; this was eliminated rapidly, essentially within a 48 h period (Appelqvist T, 2006).
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.