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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 908-084-9 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February 2015 - 17 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- EC Number:
- 908-084-9
- IUPAC Name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Appearance: Blue powder
Purity: ≥85.5%
Storage conditions: Controlled Room Temperature (15-25oC, below 70 RH%)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd mice
- Remarks:
- CBA/CaOlaHsd mice
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks old (age-matched, within one week)
- Weight at study initiation: 19.0-21.3 g (the weight variation in animals in the study did not exceed ± 20% of the mean weight)
- Housing: Group caging / mice were provided with glass tunnel-tubes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-24.8°C
- Humidity (%): 31-69 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- not specified
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: in DMSO
- Irritation: test item concentrations of 5 and 2.5% (w/v) in DMSO
- Systemic toxicity: none observed
- Ear thickness measurements: yes
- Erythema scores: 0
- Criteria used to consider a positive response: - That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
- The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: Freshly prepared in DMSO - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not specified
Results and discussion
- Positive control results:
- Larger than normal lymph nodes were observed in the positive control group. Stimulation index = 6.6
A significant lymphoproliferative response (stimulation index value of 6.6) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 0.9
- Test group / Remarks:
- B331 (0.5% (w/v) in DMSO)
- Key result
- Parameter:
- SI
- Value:
- ca. 0.9
- Test group / Remarks:
- B331 (1 % (w/v) in DMSO)
- Key result
- Parameter:
- SI
- Value:
- ca. 1.2
- Test group / Remarks:
- B331 (2.5% (w/v) in DMSO)
- Key result
- Parameter:
- SI
- Value:
- ca. 1.3
- Test group / Remarks:
- B331 (5 % (w/v) in DMSO)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: The appearance of the lymph nodes was normal in the negative (vehicle) control group and in all test item treated group. Larger than normal lymph nodes were observed in the positive control group (subjective judgement by analogy with observations of former experiments
CLINICAL OBSERVATIONS: No mortality or signs of systemic toxicity. no indications of any irritancy at the site of application
BODY WEIGHTS: No treatment related effects were observed on body weights
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of the present assay, B331, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
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.