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Diss Factsheets
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EC number: 464-070-8 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 415 (2001)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Crl:WI WU BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: diet
- Details on exposure:
- Method of administration or exposure: oral
- Frequency of treatment:
- Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week - Details on study schedule:
- Number of litters per dose/conc.: 1 at mg/kg or mg/l
- No. of animals per sex per dose:
- Male: 25 animals at 0 mg/kg or mg/l
Male: 25 animals at 43.5 mg/kg or mg/l
Male: 25 animals at 168.4 mg/kg or mg/l
Male: 25 animals at 844.4 mg/kg or mg/l
Female: 25 animals at 0 mg/kg or mg/l
Female: 25 animals at 55.3 mg/kg or mg/l
Female: 25 animals at 212.3 mg/kg or mg/l
Female: 25 animals at 1031 mg/kg or mg/l
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
due to the test substance as well as no adverse effects on
body weights and food intake up to 10000 ppm in FO rats.
No macroscopical findings due to the treatment were observed
up to 10000 ppm.
In 2000 and 10000 ppm rats clearly increased incidences
of eosinophilic or condensed cytoplasma of periportal
hepatocytes were noted. As in two 500 ppm females such
finding was present with a relative high grading the 500 ppm
concentration is considered as a borderline dose for this
finding in females.
At 2000 and 10000 ppm in males and/or females also
hepatocytes with a cobblestone pattern or showing cell
hypertrophy occurred more frequently. At 10000 ppm this
finding correlated with increased liver weights of females.
In the spleen of 10000 ppm rats congestion and/or increased
extramedullary hemopoiesis occurred more frequently than in
the other groups. At 10000 ppm this finding correlated with
increased spleen weights of males and females.
Examinations on sperms and estrus cycling as well as
histopathological evaluations of reproductive organs
revealed no substance-related effects up to 10000 ppm.
The parameters of the reproductive performance such as
insemination, fertility, gestation and rearing indices as
well as gestation length were not influenced up to
10000 ppm.
Results: F1 generation
Details on results (F1)
The litter data such as mean number of implantations and
prenatal loss, live birth, viability and lactation indices,
sex distribution, number of pups born and litter sizes were
not affected by the test substance at levels of up to
10000 ppm.
Concerning clinical findings of pups there were no changes
up to 10000 ppm in Fl pups.
The pup weights were not toxicologically relevantly changed
up to 2000 ppm. There was a slight body weight retardation
in male and female weanlings on day 28 (p > 0.05), which is
interpreted as a systemic effect due to own intake of the
test substance via diet rather than an effect on
reproduction.
At pup or weanling necropsies including organ weight
measurements no remarkable findings were noted up to
10000 ppm.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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.