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Diss Factsheets
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EC number: 946-046-3 | CAS number: -
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1988-01-11 - 1988-01-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Test procedure according to national standards
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Reaction Mass of 4-sulphophthalic acid and 3-sulphophthalic acid (ratio 3:1)
SOURCE: Sulfophthalic acid sodium and ammonium salts
3. CATEGORY APPROACH JUSTIFICATION
Sulphophthalic acid sodium and ammonium salts are different organic salts of a common acid, sulphophthalic acid. The salts dissociate rapidly in the medium (water) to the common sulphophthalic acid anion and to their different counter ions. The counter ions ammonium and sodium do not influence the solubility and the toxicity of the category members.
4. DATA MATRIX
See Read Across document attached to CSR - Qualifier:
- according to guideline
- Guideline:
- other: German industrial standard test guideline DIN 38 412, part L15.
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The doses were chosen based on a range finding study.
- the product was added to the test water without any pretreatment - Test organisms (species):
- Leuciscus idus
- Details on test organisms:
- TEST ORGANISM
- Common name: Goldorfe
- Strain: Leuciscus idus (golden variety)
- Source: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation: 6.2 cm (range: 5.7-6.9)
- Weight at study initiation: 2.7 g (range: 2.2-3.4)
- Feeding during test: no
- Frequency: Withdrawal of food before exposure: 1 day
ACCLIMATION
- Acclimation conditions (same as test or not): oil-free aerated and charcoal filtered tap water, flow-through system
Water temperature: 20-21°C
Acclimation to test water and test temperature: 3 days
- Type and amount of food: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Feeding frequency: ad libitum.
HOUSING
- Housing water: charcoal filtered dechlorinated water in continuous flow-through
- Aeration: oilfree air
- Light regime: 16 : 8 hours light : dark
- Hardness: 2.5 mM
- Oxygen concentration: > 60 % of maximum saturation
- pH: about 8.0
- Water temperature: 20 - 22 °C
- Duration of housing: about 1 month
- Medical treatment: Once with 0.05 mg/L Malachitegreen and once with 10 mg/L tetracyclinhydrochlorid (CHECK!)
- Feeding: Growing feed, F/B 50, SSNIEF Spezialdiaeten GmbH, Soest, Germany
- Amount of feed: ad libitum
- Mortality during the last 2 weeks of housing: 0.2 % - Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 96 h
- Hardness:
- Total hardness: 2.5 mmol/L
- Test temperature:
- 20 ±1 °C
- pH:
- 8.0 ± 0.3
- Dissolved oxygen:
- 7.3 - 8.4 mg/L
- Nominal and measured concentrations:
- Nominal concentrations: 5000 mg/L, 10000 mg/L.
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: aquaria open
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 2.7 g fish /L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/Mg ratio: 4 : 1
- Intervals of water quality measurement: 1, 24, 48, 72, and 96 hours
OTHER TEST CONDITIONS
- Photoperiod: 16:8 hour light:dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, symptoms - Reference substance (positive control):
- yes
- Remarks:
- Chloracetamid
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: none
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- LC50: ca. 31 mg/L (48 h) - Validity criteria fulfilled:
- yes
- Conclusions:
- The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF (water-accommodated fractions). No signs of toxicity were noted.
- Executive summary:
There are no short-term toxicity to fish studies on the reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (target substance). However, short-term toxicity to fish data (BASF, 2012) is available for the reaction mass of 1,2-benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), sodium sulphate (source substance) and it was used for read-across purposes. In a 96-hour acute toxicity study, Golden Orfe (Leuciscus Idus L., Golden Variety) were exposed to nominal concentrations of 0 and 10,000 mg/L WAF (water-accommodated fractions) under static renewal conditions. The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF. No signs of toxicity were noted.
Reference
Description of key information
There are no short-term toxicity to fish studies on the reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (target substance). However, short-term toxicity to fish data is available for the reaction mass of 1,2-benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2-benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), sodium sulphate (source substance) and it was used for read-across purposes. In a 96-hour acute toxicity study, Golden Orfe (Leuciscus Idus L., Golden Variety) were exposed to nominal concentrations of 0 and 10,000 mg/L WAF (water-accommodated fractions) under static renewal conditions. The 96-hour LL50 (loading rate of test substance resulting 50% mortality) was >10,000 mg/L nominal WAF. No signs of toxicity were noted.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 10 000 mg/L
Additional information
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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