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Diss Factsheets
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EC number: 274-040-4 | CAS number: 69563-51-5
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted according to OECD 422 guideline (GLP-compliant), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36014/W TE, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer chapter 13 for detailed read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Wistar
- Dose / conc.:
- 100 mg/kg bw (total dose)
- Remarks:
- Low Dose
- Dose / conc.:
- 300 mg/kg bw (total dose)
- Remarks:
- Medium dose
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Remarks:
- High dose
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- Based on the read across data generated from the the combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36034/W, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for reproduction/ developmental toxicity.
- Executive summary:
Data on reproduction/developmental toxicity study was not available for the target substance. To fill the data gaps, read across approach is adapted using similar substance FAT 36034/W. Read-across is claimed basis of structural relationship of the target and the source chemicals. Read across substance is FAT 36034/W and have been investigated for reproduction/developmental toxicity. On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted as per OECD 422 guideline (GLP compliance), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36034/W, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.
Reference
Effect on fertility: 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:
- Quality data, study was conducted under GLP environment
Justification for classification or non-classification
On the basis of this reproduction/developmental toxicity screening test with FAT 36034/W TE in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted according to OECD 422 guideline (GLP-compliant), based on the data generated from this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with FAT 36014/W TE, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg/d for for reproduction/ developmental toxicity.
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.
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.