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EC number: 620-056-5 | CAS number: 874195-61-6
- 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
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 July -04 Aug 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: R. Janvier, Le Genest St Isle, France
- Age at study initiation: at least 8 weeks old
- Weight at study initiation: 20.6-23.9 g
- Housing: Mice were housed individually in suspended, stainless steel, wire-mesh cages.
- Diet: certified rodent pellet diet and irradiated: A04C-10, S.A.F.E. (Scientific Animal Food and Engineering, Route de Saint Bris, Augy, France); ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2010-07-21 To: 2010-08-02 - Vehicle:
- dimethylformamide
- Concentration:
- 25, 50 and 100% (w/v)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: Concentrations of test substance in dimethylformamide were chosen based on results of a screening test, in which no irritation (measured by ear weight) was observed at concentrations of 100%. Mean ear weight value of 12.6 mg was measured in the group treated at a concentration of 100%. This represented a variation of 5.9% in relation to the value obtained in control animals (11.9 mg). The values in treated and control groups were considered similar and the formulation was not considered to be irritant at 100%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by beta-scintillation
- Criteria used to consider a positive response: A test substance is regarded as a skin sensitizer if one concentration of the test substance results in a stimulation index of three or greater, when compared to control values in the absence of skin irritation and if there is a dose-related response.
TREATMENT PREPARATION AND ADMINISTRATION:
25 µL of test substance was applied to the dorsal surface of each ear of each mouse. The application was repeated on Days 2 and 3; local irritation reactions were assessed. On Day 6 an injection of 250 µL saline (0.9% NaCl) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later (± 30 min), the draining auricular lymph nodes from each mouse were placed in an individual tube containing physiological saline and were disaggregated by crushing with a plastic piston. A cell suspension was obtained, free of connective tissue. Cell suspensions were washed with 4 mL of 0.9% physiological saline, centrifuged for 20 min at 1800 rpm and the pellets obtained were resuspended in 2 mL of 5% trichloroacetic acid and stored overnight at 5±3°C. After a final centrifugation, the pellets were resuspended in 1 mL of saline, mixed and then placed for approximately 25 min in an Ultrasonic Bath to ensure a thoroughly dispersed suspension. Once prepared cell suspensions were added to numbered scintillation pots containing 19 mL of scintillation fluid and assayed in a beta-counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The stimulation index (SI) value of the positive control alpha-hexylcinnamaldehyde was 4.5 (±1.1) at a treatment concentration of 30%, thus meeting the reliability criteria for the LLNA (SI >3: positive response).
- Key result
- Parameter:
- SI
- Remarks:
- 25%
- Value:
- 0.6
- Variability:
- SD +/- 0.2
- Test group / Remarks:
- n = 5
- Key result
- Parameter:
- SI
- Remarks:
- 50%
- Value:
- 0.5
- Variability:
- SD +/- 0.2
- Test group / Remarks:
- n = 5
- Key result
- Parameter:
- SI
- Remarks:
- 100%
- Value:
- 0.7
- Variability:
- SD +/- 0.4
- Test group / Remarks:
- n = 5
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Mortality was observed on two animals treated with the positive control. Before death these animals had soiled fur. No mortality or clinical signs were observed on the surviving animals of the positive control group, on the control animals or on animals treated with the test substance. No cutaneous reactions were observed in the vehicle, positive control or treated groups.
The disintegrations per minute (DPM) values of the test substance were 845 (± 430.7), 766 (± 297.3) and 987 (± 627.3) at treatment concentrations of 25, 50 and 100%, respectively. The DPM value of the control group was 1489 (± 430.7).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Triafamone was tested for skin sensitisation properties on mice using the local lymph node assay (LLNA) according to OECD 429 (2002). The study (M-390512-01-1) was conducted testing 25 female CBA/K mice, allocated to 5 groups containing 5 animals each. One control group received the vehicle Dimethylformamide (DMF). Three groups received the test substance at a concentration of 25%, 50% in vehicle, or 100% neat test substance. One positive control group received 30% alpha-Hexylcinnamaldehyde in vehicle. A preliminary screening test suggested that the undiluted test substance would not produce systemic toxicity or excessive local irritation. The mice were treated by topical application of the appropriate test concentrations to the dorsal surface of each ear for 3 consecutive days. 5 days following the first application of the test substance, all mice were injected with ³H-methyl thymidine (³HTdR) and sacrificed 5 h afterwards. The draining auricular lymph nodes from each mouse were excised. ³HTdR incorporation in lymphocytes was measured by beta-scintillation counting. Mortality was observed on 2 animals treated with the positive control (alpha-Hexylcinnamaldehyde). Before death these animals had soiled fur. No mortality or clinical signs were observed on the surviving animals of the positive control group, on the control animals or on animals treated with the test substance. No cutaneous reactions were observed in the vehicle, positive control or treated groups.
The mean stimulation (SI) index values of the test substance were 0.6, 0.5, and 0.7 at treatment concentrations of 25, 50 and 100%, respectively. The SI value of the positive control was 4.5 at treatment concentration of 30%, thus meeting the reliability criteria for the LLNA (SI >3: positive response). Under the test conditions, Triafamone was not considered to be a skin sensitiser, since all SI values were less than 3.
Migrated from Short description of key information:
skin sensitisation (OECD 429): not sensitising
Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.
Justification for classification or non-classification
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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