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EC number: 945-989-8 | CAS number: -
- 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
Based on results of this study, the test substance is not Classified as a Skin Sensitiser
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Details on the study design:
- The DPRA is an in chemico method, which quantifies the remaining concentration of Cysteine or Lysine containing peptide, following 24 ± 2 hours incubation with the test item at 25 ± 2.5 ºC. The synthetic peptides contain phenylalanine to aid in the detection. Relative peptide concentration is measured by high-performance liquid chromatography (HPLC) with gradient elution and UV detection at 220 nm. Cysteine and Lysine peptide percent depletion values are calculated and used in a prediction model which allow assigning the test item to one of four reactivity classes used to support the discrimination between sensitizers and non-sensitizers.
- Positive control results:
- Cinnamaldehyde used as positive control (PC) at a concentration of 100 mM in acetonitrile. The results were as expected.
- Key result
- Run / experiment:
- other: DPRA
- Parameter:
- other: DPRA
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Due to the low water soulbility of 0.00022mg/L no effect was observed.
- Interpretation of results:
- other: Water Solubility of <0.00013 mg/l meant it was not possible to test according to DPRA
- Conclusions:
- Due to the the water solubility of 0.00022 mg/L no depletion of Cysteine or Lycine was observed.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 November to 03 December 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyoeisha Chemical Co. Ltd. / Lot no. 6021874
- Expiration date of the lot/batch: February 18, 2019
- Purity test date: February 18, 2017
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: 98.94%
- Specific activity: 18000 mCi/mmole
- Locations of the label: 3H Methyl Thymidine
- Expiration date of radiochemical substance: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in original container away from heat and sunlight.
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
- other information: - Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercila laboratory animal supplier.
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 10-11 weeks
- Weight at study initiation: Minimum: 21.0 g, Maximum: 26.9 g
- Housing: Solid floor polypropylene mice cages (size: 290 mm x 220 mm x 140 mm). Each cage is fitted with a top grill having provision for keeping rodent pellet feed and water bottles. The bottom of the cages is layered with clean sterilized rice husk as bedding material.
- Diet: Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA, was provided ad libitum.
- Water: UV sterilised water (Reverse Osmosis water filtration system) was provided ad libitum.
- Acclimation period: 6 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 59 to 66%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 h artificial light and 12 h darkness, light hours being 06:00 – 18:00 h (photoperiod maintained through an automatic timer).
- IN-LIFE DATES: From: To: - Vehicle:
- dimethylformamide
- Concentration:
- 5%, 10%, 25% and 50%
- No. of animals per dose:
- 8 (2 mice/group) for preliminary assay, and 25 (5 mice/group) for main study
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test item formed a homogenous suspension in dimethylformamide up to 50% (w/v).
- Irritation: nonre
- Systemic toxicity: none
- Ear thickness measurements: yes
- Erythema scores: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: A Stimulation Index (SI) value of three or more (SI value of treated group over the control) indicates potential to cause skin sensitisation.
TREATMENT PREPARATION AND ADMINISTRATION: Three groups (G2 to G4) were treated topically for three consecutive days (days 0, 1 and 2) on the dorsal surface of both ears (25 L/ear) using a calibrated micropipette at concentrations of 10%, 25% and 50% (w/v) Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide in dimethylformamide, respectively. Mice from the vehicle control group (G1) and positive control group (G5) were handled in the same manner but received 25 L/ear of dimethylformamide and 25% (v/v) a-Hexylcinnamaldehyde in dimethylformamide, respectively.
Three groups (G2 to G4) were treated topically for three consecutive days (days 0, 1 and 2) on the dorsal surface of both ears (25 L/ear) using a calibrated micropipette at concentrations of 10%, 25% and 50% (w/v) Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide in dimethylformamide, respectively. Mice from the vehicle control group (G1) and positive control group (G5) were handled in the same manner but received 25 L/ear of dimethylformamide and 25% (v/v) a-Hexylcinnamaldehyde in dimethylformamide, respectively. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Affirmative
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- G1 - Vehicle
- Key result
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- G2 - 10 w/v in DMF
- Key result
- Parameter:
- SI
- Value:
- 1.25
- Test group / Remarks:
- 25% w/v in DMF
- Key result
- Parameter:
- SI
- Value:
- 1.73
- Test group / Remarks:
- G4 - 50% w/v in DMF
- Key result
- Parameter:
- SI
- Value:
- 13.06
- Test group / Remarks:
- 25% v/v HCA in DMF
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
; Proliferative responses in the draining lymph nodes were monitored by measuring the incorporation of 3H-methyl thymidine. These analyses revealed group mean DPM values of 307.00, 316.60, 328.80, and 531.00 for the vehicle control, 10%, 25%, and 50% (w/v)
DETAILS ON STIMULATION INDEX CALCULATION ; Stimulation Index (SI) values calculated, for groups treated with Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide, were found to be 1.03, 1.25 and 1.73 at the dose concentrations of 10%, 25% and 50% (w/v) in dimethylformamide, respectively, and 13.06 for the 25% v/v HCA treated positive control group
EC3 CALCULATION ; Ther was no EC3 calculation.
CLINICAL OBSERVATIONS: ; No clinical signs were observed in any mice from the vehicle control, positive control or any treated group at 10%, 25% and 50% (w/v)
BODY WEIGHTS; The mean body weight of positive control and Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide treated mice was comparable to that of the vehicle control group - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on results of this study, the classification for Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017) : Not Classified as a Skin Sensitiser
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Substance not classified as no sensitisation was recorded.
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