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EC number: - | 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
Key value for chemical safety assessment
Effects on fertility
Additional information
There is no study available on fertility testing of the substance compiling all endpoints required in an OECD 421/422 study. However, effects of its structural analogue (Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate) on estrous cycle, seminology and histopathology of reproductive organs were monitored in a 90 day study via additional evaluations showing no dose response effects for the tested concentration of 100, 300 and 1000 mg/kg bw/day. The OECD414 study on Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate showed no significant effects for the same tested concentration both on maternal parameters and embryo-fetal development. As a conclusion on both endpoints the NOAEL is considered to be 1000 mg/kg bw/ day.
The fertility toxicity (sexual behaviour, survival of pups and post natal development is therefore not directly assessed on Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate but a read across approach based on HEDP results, a substance harbouring a comparable physico chemical and a comparable to more severe toxicological profile, is used to demonstrate an absence of significant effects on these two endpoints. Additional information on the Read across strategy is given in chapter 13.Short description of key information:
No specific studies on reproduction are available. Data on effects on reproductive organs were assessed from the subchronic oral toxicity study (Parr2014) on the strucural analogue of the substance showing no significant effects on seminology, estrous cycle and histopathology of testis and oavaris. A developmental toxicity study (OECD414) was also presenting no effects (Bentz 2014) on the structural analogue.
Effects on developmental toxicity
Description of key information
The test item, ITC288 (batch No. B288P22E1), was administered by gavage, once daily, from Days 6 to 20 p.c., inclusive, to time-mated female Sprague-Dawley rats at dosages of 100, 300 and 1000 mg/kg/day. No effects were observed for these concentration the NOAEL for ITC288 is considered to be 1000 mg/kg/day.
On the basis of the results obtained in the available OECD 414 study:
The No Observed Adverse Effect Level (NOAEL) for maternal parameters was considered to be 1000 mg/kg/day, based on the absence of adverse effects on the dams at the dose-level.
The NOAEL for embryo-fetal development was considered to be 1000 mg/kg/day, based on the absence of adverse effects on the offspring development at the dose-level.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- One study was generated and this study is considered as realiable K1, following GLP and OECD414 protocol
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
One study evaluating the prenatal development endpoint is available. The objective of this study was to evaluate the potential toxic effects of the substance, ITC288, on the pregnant female rat and on embryonic and fetal development, following daily oral administration (gavage) to pregnant female rats from implantation to the day prior to the scheduled hysterectomy (Day 6 to Day 20 post-coitum (p.c.) inclusive) acording to the OECD 414 guideline. The test item concentrations tested were 100, 300 and 1000 mg/kg expressed as active ingredient. At termination on Day 21 p.c., there were 20, 24, 22 and 24 dams with live fetuses at 0, 100, 300 and 1000 mg/kg/day, respectively.There were no premature deaths and no test item treatment-related clinical signs, no test item treatment-related effects on mean food consumption, mean body weight, mean body weight gain, mean gravid uterus weight and mean hysterectomy data.There were no toxicologically relevant effects on mean carcass weight and mean net body weight change. There were no test item treatment-related macroscopic findings at necropsy. There were no effects on sex ratio, mean placenta weight and mean fetal/placenta weights ratio. There were no toxicologically significant effects on mean fetal weight. There were no test item treatment-related variations or malformations at external, soft tissues and skeletal examinations.
The test item, ITC288 (batch No. B288P22E1), was administered by gavage, once daily, from Days 6 to 20 p.c., inclusive, to time-mated female Sprague-Dawley rats at dosages of 100, 300 and 1000 mg/kg/day. Since no effects were observed for these concentration the NOAEL for ITC288 is considered to be 1000 mg/kg/day
Justification for selection of Effect on developmental toxicity: via oral route:
The selected study is considered as realiable K1, following GLP and OECD414 protocol
Justification for classification or non-classification
Fertility:
ITC 288/S is not classified for fertility effects due to absence of identified effects.
Development:
Based on the available OECD 414 data, no effects were identified.
ITC 288/S is considered as not toxic to reproduction, therefore no classification is required according to the EU legislation (Directive 67/548/EEC and CLP regulation (1272/2008).
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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