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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-030-8 | CAS number: 1134-94-7
- 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: Annex V
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat (Hsd)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- 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: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No substance related deaths occurred. One top dose male
waskilled on day 24 due to gavage error. During the second
half of the dosing period salivation, staining around the
mouthand urinary incontinence were observed in most top
doseanimals. These effects were not present during
recovery.There were no effects on bodyweight gain or food
consumption and no signs of toxicity were seen in mid dose
or low doseanimals.
Laboratory findings:
Haematology:
Effects were seen in top dose animals only: statistically
significant reductions in haemoglobin, haematocrit, red cell
count and mean cell haemoglobin concentration as well as an
increase in mean cell volume (both sexes) and mean cell
haemoglobin (males only). Maximum change for any parameter
=< 10%. At the end of recovery, only haemoglobin and
haematocrit had returned to normal. High reticulocyte counts
and polychromasia of the blood film were also observed in 3
females.
Clinical Chemistry:
Effects were seen in top dose animals only: a 20-30%
increase in plasma urea in both sexes at theend of treatment
and males at the end of recovery. A slight increase in
gamma glutamyl transferase levels was also seen in females
at the end of treatment and both sexes at the end of
recovery.
Urinalysis:
Effects apparently related to the presence in urine of test
substance or metabolite was a dose related increase in
cloudiness and the presence of crystals and bright red
stained globules in urine sediments. In addition, in most
top dose animals, blood was detected in the urine during
treatment and recovery (visible contamination observed for 2
males and 2 females) and red blood cells were occasionally
observed in urine sediments of some top dose animals and 3
mid dose females. A slight reduction ofspecific gravity and
doubling of protein levels wereobserved in both sexes at the
end of treatment and females at the end of recovery (top
dose only). Also present in urine sediments from both top
and mid dose animals were renal epithelial cells. The
incidence did not correlate with the severity of other
kidney lesions and levels were reduced at the end of
recovery.
Effects in organs:
In top dose animals only, absolute and relative kidney
weights were increased at the end of treatment and of
recovery; relative liver weights were slightly increased at
the end of treatment only.
Macroscopic:
Effects were observed only in top dose animals. In females
kidneys were pale and enlarged, sometimes accompanied by
pelvic dilatation. Similar effects were observed in one male
at the end of recovery. Distention of the ureter was
observed in 4 females and enlarged spleen in 3 females.
Microscopic:
In top dose animals at the end of treatment distal
nephropathy and papillary necrosis with hypertrophy of
collecting ducts were observed. Affected collecting ducts
often contained proteinaceous debris and desquamated cells.
Also observed was hyperplasia of transitional epithelium in
the renal pelvis often with slight pelvic dilatation and
epithelial hyperplasia in the urinary bladder. In mid dose
animals, distal nephropathy and papillary necrosis with
hypertrophy of collecting ducts (one male) and epithelial
hyperplasia of the urinary bladder (all females and 3 males)
were observed.
No treatment related effects were seen in low dose animals.
At the end of recovery distal nephropathy, occasionally with
papillary necrosis, was still present in top dose animals
as was minimal to slight epithelial hyperplasia in the
urinary bladder and an increase in haemosidarin
depositionin the spleen.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 50 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: Not classified
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.