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EC number: 459-990-1 | CAS number: 52411-34-4
- 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: 84/449/EWG, B.7 "ENGLISH" 84/449/EWG, B.7 (with additional recovery groups in the highest dose group and control over 14 d).
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Sprague-Dawley CD
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Carboxymethylcellulose (0,5 %)
- 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 250 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 250 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Während der gesamten Studie ist kein Tier gestorben. Die
Tiere der höchsten Dosisgruppe zeigten ab dem 3. Tag p.a.
dunkel verfärbten Urin gepaart mit rot-brauner Verfärbung
der Körperoberfläche und nassem Fell. 1 männliches Tier
zeigte begrenzt auf 2 Tage Hockstellung bzw. Anzeichen von
Dehydrierung. In der 14 tägigen Nachbeobachtungszeit waren
die Effekte reversibel. Bei den übrigen Tieren wurden keine
klinischen Effekte festgestellt.
Bei den Männchen der hohen Dosisgruppe war die
Futteraufnahme über die gesamte Studie leicht reduziert. Bei
den Weibchen und Männchen der anderen Dosisgruppen war die
Futteraufnahme normal.
Bei den männlichen und weiblichen Tieren der hohen
Dosisgruppe war die Wasseraufnahme deutlich erhöht. Der
Effekt war auch bei den männlichen Tieren der Recovery-
Gruppe noch sichtbar, während sich bei den Weibchen dieser
Gruppe die Wasseraufnahme wieder normalisierte. Bei den
übrigen Tieren war die Wasseraufnahme im Vergleich zu den
Kontrollen nicht verändert.
Bei den männlichen Tieren der höchsten Dosisgruppe war die
Körpergewichtsentwicklung gegenüber den Kontrollen leicht
reduziert. Auch bei den männlichen Tieren der Recovery-
Gruppe war die Körpergewichtsentwicklung noch leicht
reduziert. Zusätzlich zeigte ein männliches Tier am 35. Tag
einen plötzlichen Körpergewichtsverlust.
Bei den weiblichen Tieren der höchsten Dosisgruppe und den
männlichen und weiblichen Tieren der übrigen Dosisgruppen
war die Körpergewichtsentwickluung nicht beeinflusst.
"ENGLISH"
No animal died throughout the entire study. As from the 3rd
day p.a. the animals from the highest dose group exhibited
dark discoloured urine coupled with red-brown discolouration
of the surface of the body and wet coat. Limited for 2 days,
1 male animal exhibited a crouched posture and signs of
dehydration. The effects were reversible during the 14-day
follow-on observation period. No clinical effects were
determined in the remaining animals.
In the males from the high-dose group, the feed intake was
slightly reduced throughout the entire study. In the females
and males from the other dose groups the feed intake was
normal.
In the male and female animals from the high-dose group the
water intake was clearly increased. The effect could still
be seen in the male animals from the recovery group whereas
the water intake returned to normal in the females from this
group. In the other animals the water intake was unchanged
in comparison with the controls.
In the male animals from the highest dose grup the
body-weight gain was slightly reduced in comparison with the
controls. The body-weight gain in the male animals from the
recovery grup was still slightly reduced. In addition, one
male animal exhibited a sudden loss of weight on the 35th
day.
There was no influence on body-weight gain in the female
animals from the highest dose group and the male and female
animals from the other dose groups.
Laboratory findings:
Die hämatologischen und sonstigen Blutuntersuchungen ergaben
keine Auffälligkeiten.
Die männlichen Tiere der höchsten Dosisgruppe zeigten ein
erhöhtes Urinvolumen bei gleichzeitiger Reduktion der
spezifischen Dichte. Außerdem wurden bei beiden
Geschlechtern der hohen Dosisgruppe dunkler Urin und
reduzierende Substanzen festgestellt. Bei den Weibchen der
mittleren Dosisgruppe war der Urin ebenfalls dunkel gefärbt.
Bei den übrigen Tieren sowie der Recovery-Gruppe in der
Nachbehandlungszeit war die Urinanalyse unauffällig.
"ENGLISH"
The haematological and other blood investigations did not
reveal any anomalies.
The male animals from the highest dose group exhibited an
increased urine volume with simultaneous reduction in the
specific density. In addition, dark urine and reduced
substances were determined in both sexes from the high-dose
group. The urine was also dark colured in the females from
the medium-dose group.
The urine analysis did not reveal any anomalies with regard
to the remaining animals or the recovery group in the
after-treatment period.
Effects in organs:
3 weibliche Tiere der höchsten Dosisgruppe zeigten
hervorgehobene Läppchenstruktur der Leber. Bei den übrigen
Tieren war die makroskopische Untersuchung unauffällig.
Bei den Tieren der höchsten Dosisgruppe wurde eine Erhöhung
des relativen und absoluten Lebergewichts festgestellt. Bei
den weiblichen Tieren der mittleren Dosisgruppe waren die
relativen Lebergewichte erhöht. Die Lebergewichtserhöhungen
waren mit hoher Wahrscheinlichkeit eng verknüpft mit den
histopathologisch festgestellten Effekten in der Leber und
entsprechend nicht für einen adversen Effekt indikativ.
Bei den Männchen der hohen Dosisgruppe waren außerdem die
absoluten und relativen Nierengewichte erhöht. Bei den
männlichen Tieren der Recovery-Gruppe war die relative
Nierengewichtserhöhung immer noch signifikant.
Bei den Tieren der hohen und mittleren Dosisgruppe wurde
eine Vergrößerung der Hepatozyten festgestellt, was jedoch
aufgrund der Abwesenheit degenerativer Veränderungen als in
der Natur adaptiv zu bewerten ist.
Die histopathologische Untersuchung der Nieren der
männlichen Tiere der höchsten Dosisgruppe ergab eine
Verstärkung der tubulären Basophilie bzw. tubuläre
Erweiterungen, Hypertrophie des proximalen tubulären
Epithels, papilläre Veränderungen und Erosion, kristalline
Ablagerungen und Hyperplasie des pallilären und
Nierenbeckenepithels.
Ähnliche Veränderungen wurden bei den männlichen Tieren der
Recoverygruppe festgestellt.
Die weiblichen Tiere der hohen Dosisgruppe und die
männlichen und weiblichen Tiere der übrigen Dosisgruppen
zeigten keine histopathologischen Veränderungen.
"ENGLISH"
3 female animals from the highest dose group exhibited an
accentuated lobe structure of the liver. The macroscopic
investigation did not reveal any anomalies with regard to
the remaining animals. An increase in the relative and
absolute liver weight was determined in the animals from the
highest dose group. The relative liver weights were elevated
in the female animals from the medium-dose group. It is
highly probable that the liver-weight increases were closely
associated with the histopathologically determined effects
in the liver and, accordingly, are not indicative of an
adverse effect.
In the males from the high-dose group, the absolute and
relative kidney weights were increased. In the male animals
from the recovery group, the relative increase in kidney
weight was still significant.
An enlargement of the hepatocytes was determined in the
animals from the high and medium-dose group. However, in the
absence of degenerative changes, this is to be assessed as
an adaptive process in nature.
The histopathological investigation of the kidneys of the
male animals from the highest dose group revealed an
increase in tubular basophilia or tubular dilatations,
hypertrophy of the proximal tubular epithelium, papillary
changes and erosion, crystalline deposits and hyperplasia of
the pallilary and renipelvic epithelium.
Similar changes were determined in the male animals from the
recovery group.
The female animals from the high-dose group and the male and
female animals from the other dose groups did not exhibit
any histopathological changes.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 250 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.
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