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EC number: 231-511-9 | CAS number: 7601-89-0
- 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:
- 25 March - 21 July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Anhydrous Sodium Perchlorate
- IUPAC Name:
- Anhydrous Sodium Perchlorate
- Reference substance name:
- Sodium perchlorate
- EC Number:
- 231-511-9
- EC Name:
- Sodium perchlorate
- Cas Number:
- 7601-89-0
- Molecular formula:
- ClHO4.Na
- IUPAC Name:
- sodium perchlorate
- Details on test material:
- - Name of test material (as cited in study report): Anhydrous Sodium Perchlorate
- Physical state: white powder
- Analytical purity: 98.21%
- Impurities (identity and concentrations): Water: 1.67% Chlorate: (ClO3) 0.081% Chromium: (Cr) 2.08%
- Purity test date: 10 January 2008
- Lot/batch No.: lot moyen du 10/01/08 (Sponsor's filing number: GRL 0005/08)
- Expiration date of the lot/batch: February 2008
- Storage condition of test material: Room temperature, keep hermatically closed. Store away from heat and ignition sources
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 21.4 ± 1.1g
- Housing: Disposable crystal polystyrene cages (22.00x8.5x8.0cms) containing autoclaved sawdust
- Diet: SSNIFF R/M-H pelleted maintenance diet batch no. 3016578 (SSNIFF Spezialdiaten GmbH, Soest, Germany)
- Water: Tap water (filtered using a 0.22 µm filter) ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 -70
- Air changes (per hr): 12 cycles/hr of non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr (7:00 - 19:00)
IN-LIFE DATES: From: 25 March 2008 To: 07 April 2008
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Vehicle (0% test item); 1%. 2.5%, 5%, 10%, 25%, HCA 25%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Due to the unsatisfactory solubility of the test item in the first recommended vehicle
(acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles.
A solution was obtained at the maximum concentration of 25%.
- Irritation: The test item was non-irritant in the preliminary test, whatever the concentration.
The highest concentration retained for the main test was therefore the maximal practicable
concentration (25%), according to the criteria specified in the International Guidelines.
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response:
% increase in ear thickness
between day 1 and day 3 or 6 Irritation level Interpretation
< 10% I Non-irritant
10 - 30% II Slightly irritant
> 30% III Irritant
TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of
25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears,
using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an
optimized application of the test materials, the animals were placed under light isoflurane
anesthezia during the administration. No massage was performed but the tip was used to
spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
Results and discussion
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a moderate increase in
cellularity and a stimulation index exceeding the threshold value of 3 (SI = 8.83) were noted.
The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Test item 1% 1.59 Test item 2.5% 1.49 Test item 5% 1.71 Test item 10% 1.21 Test item 25% 0.54 HCA 25% 8.83
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: dpm per group: Vehicle 589.6 Test item 1% 935.26 Test item 2.5% 878.25 Test item 5% 1007.9 Test item 10% 715.00 Test item 25% 319.85 HCA 5205.31
Any other information on results incl. tables
Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles. A solution was obtained at the maximum concentration of 25%. Consequently, the concentrations selected for the preliminary test were 2.5, 5, 10 and 25%. Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (25%). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.
Treatment |
Concentration (%) |
Irritation level |
Stimulation index (SI) |
Test item |
1 |
non-irritant |
1.59 |
Test item |
2.5 |
non-irritant |
1.49 |
Test item |
5 |
non-irritant |
1.71 |
Test item |
10 |
non-irritant |
1.21 |
Test item |
25 |
non-irritant |
0.54 |
HCA |
25 |
- |
8.83 |
Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
A GLP study was conducted at CIT Laboratories France to evaluate the potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel. Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay and is therefore considered as non sensitising.
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