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Diss Factsheets
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EC number: 418-940-9 | 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
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: 1% Aqueous carboxymethyl cellulose
- Details on oral exposure:
- Method of administration:
oral 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 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 60 mg/kg bw/day
Male: 5 animals at 300 mg/kg bw/day
Female: 5 animals at mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 60 mg/kg bw/day
Female: 5 animals at 300 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
300 mg/kg:
Lethargy, ventro-lateral recumbency, hunched posture,
uncoordinated movements, quick breathing, piloerection,
ptosis, watery discharge from the eyes, brown/red staining
of the snout and dark yellow discolouration of urine.
It was noted that female rats were more affected than male
rats and the majority of symptoms was observed during the
first 10 days.
Other signs noted in treated and control groups were
considered not to present a sign of toxicity.
Laboratory findings:
Haematology:
Effects were noted on red blood cell parameters among
animals of all treated groups. A statistical significance
and a dose relationship was established in most cases.
60 or 300 mg/kg (M+F):
decreased red blood cell count, haemoglobin, haematocrit (in
300 mg/kg/day increased in M) and mean corpuscular
haemoglobin concentration. Increased mean corpuscular
volume, mean corpuscular haemoglobin and red cell
distribution width.
Decrease in red blood cell count was very large at 300 mg/kg
(50% of control values).
Increased total white blood cell count and differential
neutrophil counts (M/F) at 300 mg/kg.
Polychromatic appearance of erythrocytes, increased number
of normoblasts were seen and lymphocytes were small in size.
The latter effects were slight at 60 mg/kg and pronounced at
300 mg/kg.
At 15 mg/kg a decrease in red blood cell count (F),
haemoglobin (M+F) and haematocrit (F) was seen. Also an
increase in red blood cell distribution width (M) was seen.
Other findings were within the range of historical data.
Clinical biochemistry:
300 mg/kg:
Extremely high values for bilirubin (M+F).
Increased urea and albumin and decreased alkaline
phosphatase were found in males.
Other findings were considered to be of no toxicological
relevance, since values remained within the normal range.
Effects in organs:
Body weight:
Decreased b.w. was noted at 300 mg/kg (M+F), also the
b.w.-gain was decreased.
This effect was slight in the 60 mg/kg group.
Macroscopic examination:
300 mg/kg: spleen dark red in colour and enlarged (M+F).
Liver and kidneys were dark red discoloured (M+F).
60 mg/kg: spleen dark red in colour and enlarged (M+F).
15 mg/kg: spleen discolouration (1M).
Organ weights:
Spleen:b.w.-ratios were increased (M+F) at 60 and 300 mg/kg.
A slight increase was also noted at 15 mg/kg. A dose
response relationship was detected.
Kidney:b.w.-ratios were increased in males at all dose
levels in a dose related manner.
Liver:b.w.-ratios increased (M+F) at 300 mg/kg.
Microscopic examination:
Follicular atrophy and congestion in the spleen of all
animals, hemosiderosis all female groups and in males at 60
and 300 mg/kg. RES cell hyperplasia in females (60 and 300
mg/kg) and males (300 mg/kg).
300 mg/kg: brown-greenish pigment accumulation in the
kidneys (cortex, tubular epithelial cells) and liver.
This accumulation was also seen in the liver of some animals
at 60 mg/kg.
Increased severity of RES cell aggregates in the liver of M
+ F at 300 mg/kg.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- < 15 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: Toxic
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