Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 425-380-9 | CAS number: 7397-46-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- 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: EEC Directive 92/69, B.7
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Crl:(WI) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Dry propylene glycol (<0.2%)
- Details on oral exposure:
- Method of administration:
gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 25 mg/kg bw/day
Male: 5 animals at 125 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 25 mg/kg bw/day
Female: 5 animals at 125 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
At 125 mg/kg/day:
All animals died or were killed in extremis between day 9
and 10 of treatment.
Prior to death of or sacrifice, hunched posture or pale skin
was observed among males and lethargy, ventro-lateral
recumbency, hunched posture, uncoordinated movements, pale
skin, quick breathing, ptosis and/or piloerection were
observed in all females.
Body weights and food consumption reduced in week 1.
At 25 mg/kg/day only slightly low body weights were found in
females in week 4.
At 5 mg/kg/day no treatment-related findings noted.
Laboratory findings:
No clinical laboratory investigations were performed on the
animals receiving 125 mg/kg/day, due to mortality or interim
sacrifice of the animals of this dose group during the
study.
At 25 mg/kg/day a decrease in erythrocyte cell count,
haemoglobin and hematocrit in females only.
At 5 mg/kg/day no treatment-related findings noted.
Effects in organs:
At 125 mg/kg/day:
Macroscopic post mortem examination of the animals revealed
changes in the stomach, liver, kidneys, adrenal glands,
spleen, mesenteric lymp node and lungs.
Microscopic correlations to the findings noted at
macroscopic examination were found in the stomach
(hyperplasia with hyperkeratosis, inflammation), liver
(vacuolation, hypertrophy, pigment deposits (bile ducts),
coagulative kidneys (tubular degeneration, females only),
spleen (haemopoiesis), mesentric lymph nodes
(hyperplasia)and adrenal glands vacuolation of cortex.
No treatment-related effects were found at animals of the 5
and 25 mg/kg/day dose groups.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Xn - harmful
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.