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EC number: 424-560-4 | CAS number: 151257-01-1 SR 48001 A
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th December 1996 - 6 May 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline No. 407 "Repeated Dose 28-day Oral Toxicity Study in Rodents".
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: OFA
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA Credo
- Age at study initiation: 8 weeks
- Weight at study initiation: males 249-334 g; females: 177-232 g
- Fasting period before study: did not
- Housing: wire meshed bottom stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): free assess to tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+-2C
- Humidity (%):40-70
- Air changes (per hr):10-11
- Photoperiod (hrs dark / hrs light):12/24
IN-LIFE DATES: From: December 26 To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspension of 0.6% methylcellulose aqueous solution
- Details on oral exposure:
- Method of administration:
Gavage - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Test duration: 35 days.
also 2 week reversibility study conducted from day 36 to day51 - Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
62.5 mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
other: gavage
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 62.5 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 62.5 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
- Rationale for animal assignment (if not random):random
-
A 2 week reversibility study was conducted from days D36 to D51 where 5 males and 5 females from the control and high dose groups were observed.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:twice daily on treatment days
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule: prior to exposure and then once a week
BODY WEIGHT: Yes
- Time schedule for examinations: prior to treatment and then weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: D30 and day 50
- Anaesthetic used for blood collection: Yes (identity)
- Animals fasted: Yes for 16+2 hours
- How many animals:all animals
- Parameters checked in table [No.?] were examined. yes
URINALYSIS: Yes
- Time schedule for collection of urine: day 30 and day 50
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes 18 hours
- Parameters checked : voluem.color and clearness and multi-reagent strips
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: day 26 males, day 27 females, motor activity day 28
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity / other: all
OTHER: blood chemistry and coagulation, mortality - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
macroscpic, organ weight and microscopic-standard organs and tissues
HISTOPATHOLOGY: Yes
--organs and tissues - microscopic, bone marrow smear - Statistics:
- parametric methods:
step 1: homogeneity of intergroup vairance
step 2: equality of intergroup means
step 3: pair wise comparison of means between the treated groupd and the control groups
non-parametric methods:
1). equality of intergroup means
2). pair wise comparison of means between the treated groupd and the control groups
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS pyylism at >= 62.5 one female, solied urogenital area( only one female at 250 mg/kg
AND MORTALITY:
BODY WEIGHT AND WEIGHT GAIN : low body weight gain during first week of treatment
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): not studied
FOOD EFFICIENCY: not studied
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): not studied
OPHTHALMOSCOPIC EXAMINATION:not studied
HAEMATOLOGY:at 250 mg/kg slightly increased PCV, MCHC and MCV; at 1000 slightly increased hemoglobin levels in females
CLINICAL CHEMISTRY: coagulation no treatment effects; >=62.5 slightly increased potassium levels (females); >= 250 mg/kg slight increased ALAT activity females; at 1000 mg/kg slightly increased creatinine levels(males), total cholestrol(females) & calcium levels (females )
URINALYSIS: at >-250 mg/kg slightly increased specifc gravity ( males) at 1000 mg/kg slightly decreased pH, slightly increased urinary volume and presence of leukocytes and proteins( males)
NEUROBEHAVIOUR: at 1000 mg/kg decreased spontaneous activity in females on day 12,19,26 and 40; and decreased motor activity in females
ORGAN WEIGHTS at >- 62.5 increased absolute relative liver weight(females only); >- 250 increased relative kidney weight in males
GROSS PATHOLOGY: no treatment related changes
HISTOPATHOLOGY: at >- 62.5 very slight or slight hypertrophy of centrilobular hepatocytes ( males only); >- 250 kidney: increased number of hyalin droplets in the proximal tubular cells in males
HISTOPATHOLOGY: NEOPLASTIC (if applicable): at >-250 mg/kg very slight or slight hypertrophy of centrilobular hepatocytes in malesand at 1000 mg/kg kidneys inreased number of hyalin droplets in the proximal tubular cells in males.
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS: animals found dead on D5- dehydration, rectal prolapse blood on the limbs and the muzzle
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 62.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased absolute and/ot relative liver weights (females), very slight or slight hypertrophy of centrilobular hepatocytes ( males only),slightly increased potassium levels (females only), ptylism ( only one female)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
For the reversibility study:
D50: all clinical signes were reversible; no treatment related effects for hematology and for blood chemistry.
necropsy:
macrsopy: no treatement related chnges.
organ weight - increased relative liver wieghts in males and females
microsopy- kidneys hyalin droplets in the proximal tubular cells in males.
Applicant's summary and conclusion
- Conclusions:
- NOAEL 62.5 mg/kg bw/day(nominal).
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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