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Diss Factsheets
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EC number: 240-385-4 | CAS number: 16294-75-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1970
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: no GLP; no data on test sample; early study not according to current guideline, but including basic scientific standards of performance and reporting;
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- limited range of laboratory investigations; No FOB
- GLP compliance:
- no
- Remarks:
- predates GLP regulation
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: no data
- Weight at study initiation:m: 141g (110-167); f: 119 (98 - 134)
- Fasting period before study: no
- Housing: groups of 5
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 35 -65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 1969-09-17 To: 1969-10-17 - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): Altromin - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- continuous
- Remarks:
- Doses / Concentrations:
0 %
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
1 %
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
5%
Basis:
nominal in diet - No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: As the testmaterial was not toxic in an acute test the highest standard dose of 5% in diet was chosen
- Rationale for animal assignment (if not random): at random
- Post-exposure recovery period: all animals : 4-7 d
- Section schedule rationale (if not random): no data - Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: 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: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
- Fodd consumption measured on a weekly basis
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
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before and at the end of treatment period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters were examined: Numbers of red cells, white cells, differntial white cell count; hemoglobin content
CLINICAL CHEMISTRY: No data
URINALYSIS: Yes
- Time schedule for collection of urine: before and at the end of treatment period
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked : Protein, no further data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (heart, spleen, adrenals, kidneys, lungs, liver) - Statistics:
- no data
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 000 mg/kg diet
- Based on:
- test mat.
- Remarks:
- nominal in diet
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Critical effects observed:
- not specified
- Conclusions:
- The treatment of rats for 30 days via diet with the testmaterial did not induce any adverse effects.
- Executive summary:
Wistar-K rats were treated for 30 days via diet at concentrations of 1 and 5 % (w/w) with the testmaterial. Clinical signs, body weights, blood as well as urine were examined on a regular basis. Four to 7 days after the end of treatment all anmals were killed and examined macroscopically. Hearts, livers, lungs, kidneys, spleen and adrenal glands were investigated microscopically.
No test substance related adverse effects were detected.
The NOAEL was 50000 ppm in diet (nominal) which corresponds to about 900 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 900 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- 2 (early study with limited observational battery)
Additional information
Justification for classification or non-classification
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.