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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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.
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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