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EC number: 810-213-8 | CAS number: 1370461-06-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline- and GLP-conformant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal room was between approximately 36 - 65 % instead of 45 – 65% for several hours. This deviation to the study plan, however, does not affect the validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal room was between approximately 36 - 65 % instead of 45 – 65% for several hours. This deviation to the study plan, however, does not affect the validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst/The Netherlands
- Age at study initiation: 8-9 weeks (main study), 10-11 weeks (pre-test)
- Weight at study initiation: 18.1-21.4 g
- Housing: group
- Diet: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): approx. 45-65% (except for several hours in which humidity was 36-65%; this deviation does not affect the validity of the study)
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- propylene glycol
- Concentration:
- 0, 5, 10, 25% of test substance
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- For all statistical calculations custom made statistical program ´R` Decision Tree was used. Statistical significance was set at the five per cent level. The Dean-Dixon-Test and the Grubb’s test were used for detection of possible outliers.
- Parameter:
- SI
- Remarks on result:
- other: negative control: 1 5% test substance: 1.25 10% test substance: 1.15 25% test substance: 1.36
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 1071.5 5% test substance: 1344.5 10% test substance: 1235.5 25% test substance: 1455.1
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of Aluminum, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- to cause skin sensitisation was tested in a Local Lymph Node Assay (LLNA). Therefore, mice were treated with 0, 5, 10, or 25% test substance, and lymphocyte proliferation in the draining lymph nodes after a challenge exposure was used as read-out for sensitisation. The stimulation index determined was between 1.15 and 1.36, and therefore far below the value of 3, above which an EC3 value can be calculated. Therefore, Aluminum, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- was determined to be not sensitising to skin.
Migrated from Short description of key information:
Local lymph node assay(OECD 429, BASF SE, 2015): negative (SI <3)
Justification for selection of skin sensitisation endpoint:
GLP- and Guideline-conformant study with robust study summary
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data do not fulfill the criteria laid out in Regulation (EC) 1272/2008 (CLP). Therefore, non-classification of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- is warranted.
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.
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