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EC number: 939-221-0 | 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
Endpoint summary
Administrative data
Description of key information
LD50 (oral, rat) > 2000 mg/kg bw (Bioassay, 2012)
LD50 (dermal, rat) > 2000 mg/kg (Bioassay, 2012; Read Across)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute Oral toxicity:
In an acute oral toxicity study performed according to OECD guideline 423 and GLP, 2000 mg/kg bw of the test item Decaltal N (preparation in deionized water) were administered to two test groups of three fasted Wistar rats by gavage. The following test substance-related clinical observations were recorded:
First test group: 2000 mg/kg
No clinical signs were observed, no mortality occured
Second Test group: 2000 mg/kg
- Mortality in one out of three animals
- Poor general state in one out of three animals
- Dyspnoea in one out of three animals
- Piloerection in one out of three animals
- Lateral position in one out of three animal
Macroscopic pathological findings in the animal that died:
o Dark red discoloration of the liver
o Red discoloration of the glandular stomach
o Liquid content in the glandular stomach
o Red discoloration of the small intestine
o Liquid content in the small intestine
o Congestion in the kidneys
The mean body weight of the surviving animals increased within the normal range throughout the study period, with the exception of one female of the first test group which showed stagnation of body weight during the second post-exposure week. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.
Acute dermal toxicity
There is no data available for Decaltal N, however data from Produkt SPS can be used to assess this endpoint:
In a GLP compliant study, according to OECD guideline 402, the acute dermal toxicity of Produkt SPS following a single dermal application in male and female Wistar rats was investigated (Bioassay, 2012). A group animals (5/sex) was dermally exposed to Produkt SPS in 0.5% solution of CMC in deionized water at a dose level of 2000 mg/kg bw for 24 hours under semi-occlusive dressing and observed for 14 days. All animals survived until the end of the study period. There were no signs of systemic toxicity and no signs of skin effects. The mean body weight of the animals increased within the normal range throughout the study period, with the exception of two females which showed stagnation of body weight during the first post-exposure week, but gained weight in a normal range during the second week. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal LD50of Produkt SPS after single dermal application in male and female rats is > 2000 mg/kg bw.
Read-across justification for Decaltal N and Produkt SPS
General information |
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Common Name |
Decaltal N |
Produkt SPS |
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Chemical Name |
Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate |
Reaction mass of 1,2-Benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2- Benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), Sodium sulphate |
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Composition [g/100g] |
Tri-ammonium 4-sulfonatophthalate Tri-ammonium 3-sulfonatophthalate Di-ammonium-phthalate AmmoniumSulfate Water |
15.5 4.5 0.7 78.4 0.47 |
Tri-sodium 4- sulfonatophthalate Tri-sodium 3-sulfonatophthalate Di-sodium-phthalate Sodium Sulfate Water |
25.5 7.6 1 60.6 4.8 |
Product SPS and Decaltal N are grouped into a category based on the similar composition of these two reaction masses. Both products consist of salts of sulfophthalic acid and – mainly – of sodium sulphate (Product SPS) or ammonium sulphate (Decaltal N), respectively. The exact compositions of both products were determined by 1H-NMR spectroscopy and are listed in the table above.
Considering that sodiumsulfate as well as ammonium sulfate are not classified for any toxicological-relevant endpoint according to Directive 67/548/EC and 1272/2008/EC (CLP), it can be concluded that their toxicological hazardfor human health is insignificant. As a consequence, the toxicity of Product SPS and Decaltal N is supposed to be mainly driven by the salts of sulfophthalic acid as both ammonium and sodium ions are naturally occurring in the human body and their concentrations are tightly regulated, they do not pose a health hazard per se.The content of the salts of sulfophthalic acid is higher in Produkt SPS as compared to Decaltal N (approximately 33% versus 24%). Hence, using the toxicological results of Produkt SPS for the assessment of the toxicity of Decaltal N displays a worst-case scenario and therefore a reasonable and justified approach.
Justification for classification or non-classification
Based on the available acute oral and dermal toxicity study, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP).
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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