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Diss Factsheets
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EC number: 278-169-7 | CAS number: 75277-39-3
- 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
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
The read-across source substance was found to have no adverse effect on the development of rats. The No Observed Effect Level (NOEL) for maternal toxicity and embryofetal development is 1000 mg/kg bw/day (reference 7.8.2 -1).
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:
- The guideline study using the read-across substance is of high quality and reliable without restrictions.
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
No study data with the test item is available for developmental toxicity. Therefore, a read-across to the read-across source substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the teratogenic potential of the test item.
Developmental toxicity study
The objective of this prenatal developmental toxicity GLP-study according to OECD TG 414 was to evaluate the potential toxic effects of the read-across source substance on the pregnant 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 19 post-coitum inclusive).
Four groups of 24 mated female Sprague-Dawley rats, received the test item by oral administration (gavage) at 100, 300 or 1000 mg/kg bw/day from day 6 to day 19 post-coitum. A group of 24 mated females was given the vehicle alone (purified water) under the same experimental conditions and acted as the control group. Clinical signs and mortality were checked daily. Body weight and food consumption were recorded at designated intervals. On day 20 post-coitum, the dams were sacrificed and subjected to macroscopic examination. The gravid uterus was weighed to allow calculation of the net body weight gain of females. The fetuses were removed by hysterectomy. The litter parameters were recorded, namely: number of corpora lutea, implantation sites, early and late resorptions, dead and live fetuses. The fetuses were weighed, sexed and submitted to external examination of the soft tissue and the other half to a detailed examination of the skeleton (bone and cartilage).
There was no mortality in any group.There were no treatment-related clinical signs in any group. The food consumption and body weight were unaffected by the treatment with the test item. No macroscopic findings that were related to the treatment were noted at any dose-level. No treatment-related effect was noted on litter data parameters, namely: corpora lutea, implantation sites, post-implantation loss, number of live fetuses and fetal body weight. No fetal external, soft tissue or skeletal variations or malformations were observed that were considered to be attributable to the treatment with the test item.
In conclusion, the test item, when administered to pregnant female rats from day 6 to day 19 post-coitum was well tolerated at all dose-levels. No effect on litter data parameters and fetal development were observed.
In conclusion, 1000 mg/kg bw/day is the No Observed Effect Level (NOEL) for maternal toxicity and embryofetal development.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on developmental toxicity, the test item does not need to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.
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.