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EC number: 947-971-5 | 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
Endpoint summary
Administrative data
Description of key information
Oral toxicity: Approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat (non-guideline study conducted to GLP standards).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 October 1987 to 06 November 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The approximate lethal dose (ALD) of test material was determined following administration of various doses to rats by gavage in a single dose. The ALD was defined as the lowest dose administered which caused death on the day of dosing or within 14-days post exposure.
- GLP compliance:
- yes
- Test type:
- other: lethal dose
- Limit test:
- yes
- Specific details on test material used for the study:
- - Physical form: White to light tan paste
- Purity: 80 % active ingredient
- Lot: 751 - Species:
- rat
- Strain:
- other: Crl:CDBR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- ANIMAL HUSBANDRY
- Male Crl:CDBR rats, approximately 7 weeks old, were received from Charles River Breeding laboratories, Kingston, New York.
- Rats were housed singly in suspended, stainless steel, wire-mesh cages.
- Each rat was assigned a unique identification number which was recorded on a card affixed to the cage.
- Purina Certified Rodent Chow #5002 and water were available ad libitum.
- Rats were quarantined, weighed and observed for general health for approximately one week prior to testing.
- Animal rooms were maintained on a timer-controlled 12-hour light and 12-hour dark cycle.
- Environmental targets for the animal rooms were 23 ± 2 °C and relative humidity of 50 ± 10 %. Excursions outside of these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- PROTOCOL
- The test material was suspended in distilled water and administered to one rat per dose rate by intragastric intubation.
- Dose rates administered ranged from 2300 to 11000 mg/kg bw in increments of approximately 50 %. Additionally, one rat was dosed at 670 mg/kg bw.
- The dosing day was test day one.
- Post-exposure day 14 was test day 15.
- Following administration of the test material, rats were observed for clinical signs of toxicity.
- Surviving rats were weighed and observed daily until signs of toxicity subsided and then at least three times per week during the 14-day post-exposure period.
- Observations were made daily throughout the study. - Doses:
- 670, 2300, 3400, 5000, 7500 and 11000 mg/kg bw
- No. of animals per sex per dose:
- One
- Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- other: approximate lethal dose
- Effect level:
- > 11 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No unplanned animal deaths took place during the study
- Clinical signs:
- other: NON-LETHAL DOSES - Rats dosed at 6709 or 2300 mg/kg bw exhibited no clinical signs of toxicity during the study. - Clinical signs of toxicity observed in rats dosed at 3400 to 11000 mg/kg bw were lung noise, lethargic behaviour, diarrhoea and yellow or br
- Gross pathology:
- - Not investigated
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat. The material was considered to be very low in toxicity (ALD > 5000 mg/kg bw) when administered as a single oral dose.
- Executive summary:
The approximate lethal dose (ALD) was investigated by administering 670, 2300, 3400, 5000, 7500 or 11000 mg/kg bw of test material to a male rat by gavage in a single dose under GLP conditions. No mortality was observed. Rats dosed at 6709 or 2300 mg/kg bw exhibited no clinical signs of toxicity during the study. Clinical signs of toxicity observed in rats dosed at 3400 to 11000 mg/kg bw were lung noise, lethargic behaviour, diarrhoea and yellow or brown stained perineum. Slight to severe weight losses (up to 13 % of initial body weight) were observed after dosing in most rats. Under the conditions of the study, the approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat. The material was considered to be very low in toxicity (ALD > 5000 mg/kg bw) when administered as a single oral dose.
Reference
Dosage (mg/kg) |
Dose volume (mL) |
Suspension concentration (mg/mL) |
Initial body weight (g) |
Mortality |
670 |
0.85 |
200 |
253 |
No |
2300 |
2.8 |
200 |
243 |
No |
3400 |
2.9 |
300 |
259 |
No |
5000 |
4.1 |
300 |
247 |
No |
7500 |
6.8* |
300 |
272 |
No |
11000 |
9.5* |
300 |
260 |
No |
* Administered in two portions, 15 minutes apart
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral toxicity: In the key study, the approximate lethal dose (ALD) was investigated by administering 670, 2300, 3400, 5000, 7500 or 11000 mg/kg bw of test material to a male rat by gavage in a single dose under GLP conditions. No mortality was observed. Rats dosed at 6709 or 2300 mg/kg bw exhibited no clinical signs of toxicity during the study. Clinical signs of toxicity observed in rats dosed at 3400 to 11000 mg/kg bw were lung noise, lethargic behaviour, diarrhoea and yellow or brown stained perineum. Slight to severe weight losses (up to 13 % of initial body weight) were observed after dosing in most rats. Under the conditions of the study, the approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat. The material was considered to be very low in toxicity (ALD > 5000 mg/kg bw) when administered as a single oral dose.
Justification for classification or non-classification
Oral toxicity: The approximate lethal dose (ALD) for the test material was found to be > 11000 mg/kg bw in the rat and classification is not required under the terms of Regulation (EC) No 1272/2008.
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