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EC number: 273-732-3 | CAS number: 69012-32-4 By-product of smelting of phosphate rock, silica and coke in manufacture of phosphorus.
- 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:
- 20 January 2010 - 12 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 429 and under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Slags, phosphorus-manufg.
- EC Number:
- 273-732-3
- EC Name:
- Slags, phosphorus-manufg.
- Cas Number:
- 69012-32-4
- Molecular formula:
- not applicable due to the multi constituent mineral structure of the substance
- IUPAC Name:
- aluminium(3+) heptacalcium magnesium(2+) λ²-iron(2+) disodium tris([(trioxidosilyl)oxy]silanetris(olate)) oxosilanebis(olate) hydroxysilanoylolate difluoride
- Details on test material:
- - Name of test material (as cited in study report): Phosphorous slag
- Physical state: Solid
- Analytical purity: Confidential information
- Expiration date of the lot/batch: Confidential information
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbrescle Cedex, France
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: Within +/- 20% of the sex mean
- Housing: Individually, according to guideline
- Diet (e.g. ad libitum): Ad libitum, pelleted rodent diet
- Water (e.g. ad libitum): Ad libitum, tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-23.4
- Humidity (%): 39-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0% (vehicle), 10%, 25% and 50%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Concentration: 25% and 50% (maximum concentration in accordance with test guideline)
- Irritation: Erythema (score: 1) was noted in both ears of the tested animal (n=1) at 50% concentration. This concentration was selected as maximum concentration for the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA) - individual animal approach
- Criteria used to consider a positive response (DSD/CLP): Stimulation Index (SI) >3
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance formulation (w/w) were prepared within 4 hours prior to each treatment. Homogeneity was obtained to visually acceptable levels. Formulation was applied to the dorsal ears on three consecutive days. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Calculated SI values for 5%, 10% and 25% hexyl cinnamic aldehyde were 1.4, 1.2 and 5.1, respectively. An EC3 value of 16.9% was calculated using linear interpolation. This proves the reliability of the model, as the EC3 value is within the acceptable range of 2% and 20%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: - 10%: 1.3 - 25%: 2.0 - 50%: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: - 0%: 322 - 10%: 425 - 25%: 650 - 50%: 512
Any other information on results incl. tables
- No mortality and no symptoms of systemic toxicity were observed
- Slight irritation observed in the animals of the 50% concentration group
- No effect on body weight (gain)
- All auricular lymph nodes considered normal in size
- No macroscopic abnormalities of area surrounding lymph nodes
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, a maximum Stimulation Index (SI) of 2.0 was calculated. Considering the SI threshold value of 3 as stated in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, the substance does not need to be classified as sensitiser up to concentrations of 50%.
- Executive summary:
This Local Lymph Node Assay (OECD 429) was performed to determine the sensitising potential of Phosphorous slag in mice. Four groups of 5 female mice were used and exposed to concentrations of 0%, 10%, 25% and 50% in propylene glycol. Clinical observations and body weights were recorded, irritation was scored and macroscopic examination of the lymph node area was performed. The lymph node proliferation was determined.
The counts per minute measured by scintillation counting were converted to disintegrations per minute and were 322, 425, 650 and 512 dpm for the 0%, 10%, 25% and 50% concentration groups, respectively. This corresponds with a lymph node proliferation of 1.3, 2.0 and 1.6 for the treated groups, calculated as the Stimulation Index (SI). No mortality and no symptoms of systemic toxicity were observed. Slight irritation was noted in the animals of the 50% concentration group. No effects on body weight (gain) were observed. All auricular lymph nodes considered normal in size and no macroscopic abnormalities of area surrounding lymph nodes were seen.
Under the conditions of this study, a maximum Stimulation Index (SI) of 2.0 was calculated. Considering the SI threshold value of 3 as stated in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, the substance does not need to be classified as sensitiser up to concentrations of 50%.
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