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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 471-110-8 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: 96/54/EG, B.7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Rj:WI (IOPS Han.)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: diet
- Details on oral exposure:
- Method of administration:
oral - 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 1.5 mg/kg bw/day
Male: 5 animals at 9.7 mg/kg bw/day
Male: 5 animals at 39.1 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 1.6 mg/kg bw/day
Female: 5 animals at 10.9 mg/kg bw/day
Female: 5 animals at 42.7 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No mortality occurred during the study period and no
clinical signs were recorded in either sex.
At 500 ppm mean body weights were reduced in males between
4 % and 13 % (not statistically significant) throughout the
study compared to controls. At the end of treatment the
overall mean body weight gain was reduced by 27 %
(statistically significant). In females, body weight
parameters were unaffected by treatment. Mean food
consumption in males was reduced between 9 % and 20 %
throughout the study. In females, mean food consumption was
reduced between 7 and 8 % throughout the study, when
compared to controls.
No test substance-related effects were detected during
neurotoxicity assessment including extraploratory locomotor
activity, open field observation, sensory reactivity and
grip strength.
Laboratory findings:
There were no test substance-related effects on haematology,
clinical biochemistry and urinalysis data at termination of
the treatment which could be considered of biological
significance.
Effects in organs:
In males treated at 500 ppm, mean absolute and relative
testis weights were statistically significant reduced
between 59 % and 65 %, and mean absolute and relative
epididymides weights between 29 % and 38 %, when compared
to controls.
At necropsy atrophic/small and/or soft testis and
atrophic/small epididymides were found in all males at
500 ppm and in one male at 120 ppm.
Test substance-related lesions were observed in the brain,
testis, epididymis and kidneys at 500 ppm. In the brain,
minimal to moderate cerebella demyelisation was observed in
3/5 males and 3/5 females. In the testis, marked diffuse
tubular degeneration (bilateral) with loss of germ cells,
multinucleated giant cells and sloughing of germ cells were
seen in all males. Correlating to these findings relevant
changes were noted in the epididymis of the same animals.
There were marked to severe oligospermia (bilateral) and
exfoliated germ cells (bilateral) in all males. Minimal
tubular hyaline droplets were found in the proximal tubules
of the kidneys in 3/5 males. Accumulation of hyaline
droplets in kidney tubules was known as a species and
sex-specific phenomenon of hydrocarbon nephropathy, which
results from the excessive accumulation of alpha 2µ-globulin
in renal proximal tubular epithelial cells. Alpha
2µ-globulin is found only in the proximal tubular epithelium
of adult male rats. This effect was considered not to
represent serious damage to health, as defined by the
criteria given in the Council Directive 67/548/EEC (Annex
VI).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 42.7 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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)