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EC number: 237-075-6 | CAS number: 13598-65-7
- 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:
- 07 June 2011 to 8 September 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- 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)
- Remarks:
- Date of inspection: 20 July 2010 Date of signature: 29 October 2010
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ammonium perrhenate
- EC Number:
- 237-075-6
- EC Name:
- Ammonium perrhenate
- Cas Number:
- 13598-65-7
- Molecular formula:
- H4N.O4Re
- IUPAC Name:
- Ammonium oxido(trioxo)rhenium
- Details on test material:
- - Name of test material (as cited in study report): Ammonium perrhenate
- Substance type: white solid
- Physical state: Solid
- Analytical purity: 100%
- Lot/batch No.: 17410
- Expiration date of the lot/batch: 28 July 2011
- Stability under test conditions: Not tested. Assumed to be stable.
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxfordshire, United Kingdom
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet : 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxfordshire, United Kingdom. Ad libitum.
- Water : mains tap water, ad libitum.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness
IN-LIFE DATES: From: Day 1 To: Day 6
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary test: 25% w/w
Main test: 25%, 10%, 5% w/w - No. of animals per dose:
- 4 animals per dose group and vehicle control in the main test.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Dimethyl formamide was chosen as vehicle as it produced the highest concentration that was suitable for dosing (25%).
- Irritation: Local irritation was scored daily according to the scale in OECD TG 429. Ear thickness was also measured.
- Lymph node proliferation response: No assessment of lymph node proliferation was made in the preliminary screening test.
- Others: Overt signs and body weights were recorded.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
The mice were treated by daily application of 25 µl of the test item (25%, 10% and 5% w/w) in dimethyl formamide, to the dorsal surface of each ear for three consecutive days. A further group received vehicle alone.
- Name of test method: Radioactive labelling to measure lymph node cell proliferation (expressed as Stimulation Index) determined five days following the first topical application.
- Criteria used to consider a positive response: The test item will be regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitiser".
- Others: Any signs of toxicity or signs of ill health as well as bodyweight were recorded.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was freshly prepared as a solution in dimethyl formamide. The test item was formulated within two hours of being applied to the test system.
Rainge finding study: One mouse was treated by daily application of 25 µl of the test item at a concentration of 25% w/w in dimethyl formamide, to the dorsal surface of each ear for three consecutive days.
Main study: The mice were treated by daily application of 25 µl of the test item (25%, 10% and 5% w/w) in dimethyl formamide, to the dorsal surface of each ear for three consecutive days. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- The Stimulation Index expressed as the mean radioactive incorporation for the group treated with α-Hexylcinnamaldehyde, tech, 85% (as a solution in dimethyl formamide at a concentration of 15% v/v) divided by the mean radioactive incorporation of the vehicle control group was 4.77. Therefore α-Hexylcinnamaldehyde, tech, 85% was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index: 1.32 at 5%, 1.11 at 10% and 0.70 at 25%. See the table in 'any other information on results incl. tables'.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Disintegrations per minute: 12653.32 for vehicle control, 16664.93 at 5%, 14093.60 at 10% and 8863.04 at 25%.
Any other information on results incl. tables
Table Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
12653.32 |
1581.67 |
na |
na |
5 |
16664.93 |
2083.12 |
1.32 |
Negative |
10 |
14093.60 |
1761.70 |
1.11 |
Negative |
25 |
8863.04 |
1107.88 |
0.70 |
Negative |
dpm = Disintegrations per minute
a = Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to be compatible with the OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 22 July 2010) and Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 25% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test item as a solution in dimethyl formamide at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with dimethyl formamide alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%w/w) in
dimethyl formamideStimulation Index
Result
5
1.32
Negative
10
1.11
Negative
25
0.70
Negative
The test item was considered to be a non-sensitiser under the conditions of the test.
Ammonium perrhenate does not meet the criteria for classification of skin sensitiser according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
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