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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-228-2 | CAS number: 96556-05-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 03 March 2008 to 16 April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine dihydrochlorid
- Molecular formula:
- C9H21N3, 2 HCl
- IUPAC Name:
- Octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine dihydrochlorid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SAJ 07-065
- Expiration date of the lot/batch: 23 October 2009
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at 2-8 °C
- Stability under test conditions: in water, saline, propylene glycol, and carboxymethylcellulose >1 day at room temperature, > 2 days in the refrigerator, >3 days in the freezer
- Solubility and stability of the test substance in the solvent/vehicle: the highest concentration which can be used was 25% solution in ethanol:deionised water (70/30)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: -
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- OlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands - B.V. Postbus 6174 - NL 5960 AD Horst
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: -
- Age at study initiation: 8-10 weeks
- Weight at study initiation: from 18.7g to 21.5g
- Housing: single, in Makrolon Type 1 cages with wire mesh top, and granulated soft wood bedding
- Diet: pelleted standard diet ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
- Water: tap water, ad libitum (Gemeindewerke, D-64380 Rossdorf)
- Acclimation period: at least 5 days under test conditions
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30-70%
- Air changes (per hr): not available
- Photoperiod: 12 hrs dark / 12 hrs light
- IN-LIFE DATES: not available
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:deionised water (70/30)
- Concentration:
- 5,10 and 25%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: the highest concentration which can be technically used was 25% solution ins ethanol:deionised water (70/30)
- Irritation: no sign of irritation was observed up to 25%
- Systemic toxicity: none
- Ear thickness measurements: not measure
- Erythema scores:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: random
- Criteria used to consider a positive response:
* exposure to at least one concentration of test item results in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated yb the stimulation index.
* the data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
The solutions were made freshly before each dosing occasion. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- 5%: SI = 1.78
10%: SI = 1.84
25%: SI = 4.87
EC3 = 15.7% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.45
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.84
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.42
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
See table
DETAILS ON STIMULATION INDEX CALCULATION
See table
EC3 CALCULATION: not determined since all SI are below 3.
CLINICAL OBSERVATIONS: none
BODY WEIGHTS: the BW recorded prior to the first application and prior to treatment witth 3HTdR was within the range commonly recorded for animals of this strain and age
Any other information on results incl. tables
Results:
Test item concentration % (w/v) | Group | DPM | DPM-BG | number of lymph nodes | DPM per lymph node | SI |
BG I | 48 | |||||
BG II | 25 | |||||
0 (Control) | 1 | 2865 | 2829 | 8 | 353.6 | |
5 | 2 | 4150 | 4114 | 8 | 514.2 | 1.45 |
10 | 3 | 5251 | 5215 | 8 | 651.8 | 1.84 |
25 | 4 |
4060 | 4024 | 8 | 502.9 | 1.42 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not a skin sensitiser under the test conditions.
- Executive summary:
In a dermal sensitization study with TACN dichloride at 5, 10 and 25% in ethanol:deionised water (70/30), young adult female mice (4/group) were tested using the LLNA method according to OECD 429 guideline. No clinical signs (systemic or local) nor mortality were reported.
In this study, TACN dichloride is not a dermal sensitizer according to CLP criteria.
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.