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Diss Factsheets
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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
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Endpoint summary
Administrative data
Description of key information
Read Across: OECD 422 (Harlan, 2013): NOAEL = 1000 mg/kg (systemic and local)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
There is no data available for Decaltal N, however data from Produkt SPS can be used to assess this endpoint:
Produkt SPS was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test. The study was conducted according to OECD 422 guideline and GLP (Harlan, 2013).
The following dose levels were applied:
Group 1: 0 mg/kg body weight/day (control group)
Group 2: 100 mg/kg body weight/day
Group 3: 300 mg/kg body weight/day
Group 4: 1000 mg/kg body weight/day
A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (Milli-Q-Water).
The following results were obtained:
Parent Animals:
General Tolerability
All animals survived until scheduled necropsy. No clinical signs were noted in males and females at any dose level.
Food Consumption and Body Weights
No adverse effects on mean food consumption and mean body weights of males and females were observed at any dose level.
Clinical Laboratory Investigations
No test item-related findings were noted during the clinical laboratory investigations.
Reproduction and Breeding Data
Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item. No effects on implantation loss or postnatal loss were observed.
Organ Weights
No effects on organ weights were noted in any group.
Macroscopical Findings and Histopathological Examinations
There were no test item-related macroscopical or microscopical findings in any group.
Litter Data - F1 Pups
Findings at First Litter Check and during Lactation
The mean number of pups at first litter check was not affected by the treatment with the test item. The sex ratio was also not affected. No abnormal pup was noted at any dose level.
Pup Weights to Day 4 Post Partum
No effects on pup weight and pup weight gain were observed.
Macroscopical Findings
At necropsy of pups, there were no abnormal findings.
Conclusion
Based on these results the NOAEL (No Observed Adverse Effect Level) for general and reproductive toxicity was considered to be 1000 mg/kg body weight/day.
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 data, the test substance is not classified with regard to repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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