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Diss Factsheets
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EC number: 254-400-7 | CAS number: 39290-78-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Somewhere during 1978
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Rel. 3 because information on substance identity and composition is lacking. Batch No. is given and method is comparable to guideline 401. If substance identity and composition is known reliability can turn into 2 (limited reported study, pre-GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Principles other than guideline:
- no necropsy of survivors
- very high concentrations tested - GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- - Name of test material (as cited in study report): Chlorosulfate basique d'aluminium
- Physical state: brown-grey liquid
- Other: received 125 ml
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO
- Age at study initiation: no info
- Weight at study initiation: 145 - 165 g
- Fasting period before study: approximately 19 hours
- Housing: 5 per cage
- Diet (e.g. ad libitum): IFFARAT
- Water (e.g. ad libitum): water
- Acclimation period: no info
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50 ± 10
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): no info
IN-LIFE DATES: No info
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not applicable
MAXIMUM DOSE VOLUME APPLIED: 14 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable - Doses:
- Main study: 7.2 g/kg, 9.6 g/kg, 12 g/kg, 14.4 g/kg, 16.8 g/kg
Preliminary study: 6 g/kg, 12 g/kg, 24 g/kg - No. of animals per sex per dose:
- Main study: 5
Preliminary study: 2 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations after 15 minutes, 1, 2 and 6 hours and every day during 14 days and autopsy of the animals which died. Weighing on Day 0, 1, 2, 4, 7 and 14.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculation of the LD50 by 3 methods:
- Probit method (Bliss - 1935)
- The method of Litchfield and Wilcoxon (1949)
- The method of arcsinus
1. Bliss, C.I. The comparison of dosage-mortality data - Ann. Appl. Biol. 22, 307-333, 1935
Bliss, C.I. The calculation of the dosage-mortality curve - Ann. Appl. Biol. - 22, 134-167, 1935
Bliss, C.I. The determination of the dosage-mortality curve from small numbers - Quart. J; Pham. and Pharmacol., 11 192-216,1935
2. Litchfield J.T., Wilcoxon J.R. and F.: A simplified method of evaluating dose-effect experiments. The Journal of Pharmacology and Experimental Therapeutics, 96, 2, 99-113, 1949
Results and discussion
- Preliminary study:
- Mortality:
- Dose group 6 g/kg: no mortality
- Dose group 12 g/kg: 2 female animals died
- Dose group 24 g/kg: 2 male and 2 female animals died
Clinical signs:
- Dose group 24 g/kg: at 1 hour observation zero spontaneous activity, absence of reflex overturning, piloerection.
- Dose group 12 g/kg: at 1 hour observation apathy, piloerection, motor difficulties and rapid breathing. After 1 day: Prostration and piloerection among the survivors.
- Dose group 6 g/kg: Apathy and piloerection.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 11 800 mg/kg bw
- 95% CL:
- > 10 460 - < 13 360
- Remarks on result:
- other: Based on Litchfield and Wilcoxon
- Mortality:
- - Dose group 7.2 g/kg: no mortality
- Dose group 9.6 g/kg: no mortality
- Dose group 12 g/kg: 2 males and 4 females died
- Dose group 14.4 g/kg: 5 males and 4 females died
- Dose group 16.8 g/kg: 5 males and 5 females died - Clinical signs:
- - Dose group 7.2 g/kg: Slowdown in spontaneous activity (2 h); at 6 h also piloerection; after 1 day normal behaviour.
- Dose group 9.6 g/kg: Same symptoms as the previous dose.
- Dose group 12 g/kg: low spontaneous activity (2 h); low activity, depression and piloerection (6 h); low activity, depression among all the females and one male, piloerection, one female had blood in her urine, one male had bladder haemorrhagic fever (Day 1); persistence of a slight piloerection among the survivors on Day 3; the surviving animals showed normal behaviour on Day 4.
- Dose groups 14.4 g/kg and 16.8 g/kg: slowdown in spontaneous activity (1 h); also depression, piloerection and staggering gait after 6 hours; on Day 1 the remaining animal died. - Body weight:
- Bodyweight gains per dose group were recorded for all surviving rats.
- Gross pathology:
- - Dose group 12 g/kg: the autopsy by two males and one female showed bleeding of their stomachs and a contracted jejunum.
- Dose groups 14.4 and 16.8 g/kg: no info - Other findings:
- No.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose to rats of Chlorosulfate basique d’aluminium (WAC®) was found to be 11800 mg/kg bodyweight. Based on the assumption that approximately 20% of this test material consists of salts the acute oral median lethal dose to rats of the salts is 2360 mg/kg bodyweight. According to OECD-GHS the salts of chlorosulfate basique d’aluminium is classified as category 5.
- Executive summary:
An acute oral toxicity was performed. The method of the study shows similarities to OECD Guideline 401 (Acute Oral Toxicity), and is however not performed according to GLP standards. The test material, Chlorosulfate basique d’aluminium (WAC®) was evaluated for its acute oral toxicity potential in rats when administered as gavage doses at levels of 7200, 9600, 12000, 14400, 16800 mg/kg bw to 5 males and 5 females per dose group.
At 12000 mg/kg 6 animals died, at 14400 mg/kg 9 animals died and at 16800 mg/kg 10 animals died.
Clinical signs of toxicity included pilo-erection and depression; recovery in surviving animals was complete not later than Day 4.
Gross pathologic examination for the deceased animals revealed bleeding of the stomachs.
Acute oral LD50(test material) = 11800 mg/kg bw.
Based on the assumption that approximately 20% of this test material consists of salts, acute oral LD50(salts) = 2360 mg/kg bw
Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and classified in category 5 according to the GHS.
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