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Diss Factsheets
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EC number: 410-210-8 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-10-08 to 1991-11-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline 407 (adopted 1981) study, GLP compliant. Acceptable deviations from OECD guideline 407 adopted 2008: less organs weighed and microscopically examined, no specific neurobehavioural examinations performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- adopted 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- of April 25, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- IN-LIFE DATES: From: October 8, 1991 To: November 6, 1991 (treatment groups), December 4, 1991 (recovery groups)
no further information available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % carboxymethylcelluloseand 0.1% Tween 80 in distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Suspensions of the test article in the selected vehicle at the appropriate concentrations were freshly prepared every day immediately prior to the dosing of the animals and administered within about 2 hours.
VEHICLE
- Amount of vehicle (if gavage): 10 mL/bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Control analyses of the test article concentration in the vehicle were carried out at all dose levels on samples collected once per experimental week. The samples were collected after administration, immediately deep frozen and sent to the analytical laboratories. The samples were analysed spectrophotometrically. The analytical results confirmed the nominal concentrations.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 animals per sex per dose, additional 5 animals per sex at 0 and 1000 mg/kg bw/d (recovery group animals)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were fixed based on the results of an acute oral toxicity study in rats (LD50 > 2000 mg/kg bw) and a repeated dose oral toxicity study in rats (a 14-day range finding study in which the test article was tolerated up to a daily dose of 1000 mg/kg bw/day
for 14 days without significant toxicological consequences).
- Post-exposure recovery period in satellite groups: 4 weeks - Positive control:
- Not required
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: examination was carried out daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: examination was carried out daily.
BODY WEIGHT: Yes
- Time schedule for examinations: The weight of all animals was recorded individually at weekly (midweek) weighing sessions. The first weights were recorded during the acclimatisation period.
FOOD CONSUNPTION AND EFFICIENCY: yes
- - Time schedule: weekly
The food consumption ratios were calculated as mean of individual ratios according to the following formula: weekly food consumption (g)/ midweek bodyweight (g) x 1000/7
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
No further information available.
CLINICAL CHEMISTRY: Yes
No further information available.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
At autopsy the following weights were recorded from all animals: body (exsanguinated), brain, liver, kidneys, adrenals, ovaries/testes
HISTOPATHOLOGY: Yes
After fixation, organ samples of all animals of the treatment groups were taken, embedded in paraplast, sectioned at 3-5 microns, stained with hematoxylin and eosin, and subjected to a microscopical examination:
spleen
heart
liver
kidney, both
adrenal gland, both
any organ with gross lesions
In addition, liver identified as possible target organ was examined microscopically in all animals of the recovery groups. - Statistics:
- Each treated group i s compared to the control group by Lepage's two-sample test. This test is a combination of Wilcoxon and Ansari-Bradley statistics, i . e . a combined test for location and dispersion. The Lepage t est has a good power against the more general alternative that the distributions differ not only
in location but also in dispersion. Increasing or decreasing trends in location from control to the highest dose group are tested by Jonckheere's test for ordered alternatives. This test is sensitive to monotone dose-related treatment effects.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
CLINICAL SIGNS AND MORTALITY
No death occurred during the study and no relevant treatment-related clinical signs were observed during the study.
BODY WEIGHT AND WEIGHT GAIN
No relevant differences in bodyweight development were recorded
during the study.
FOOD EFFICIENCY
No relevant differences in mean food consumption were recorded for treated and control animals and mean food consumption ratios for treated groups were comparable to those of the control groups.
HAEMATOLOGY
The treatment had no effect on hematological parameters investigated.
CLINICAL CHEMISTRY
No evidence of a treatment-related effect on blood chemistry parameters was apparent.
ORGAN WEIGHTS
The analysis of organ weights revealed no relevant differences between treated and control groups.
GROSS PATHOLOGY and HISTOPATHOLOGY:
All macroscopical and microscopical findings were considered to be unrelated to the treatment.
Applicant's summary and conclusion
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.
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