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EC number: 286-185-0 | CAS number: 85187-95-7
- 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
LD50(male/female) = 2122 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From December 12, 1978 to January 10, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight before treatment
- Housing: housed in groups of 5 in Macrolon cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle : 10, 20 ml/kg
The test item was suspended. Before treatment the suspension was homogeneously suspended with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. - Doses:
- Doses (mg/kg bw) : 1000, 2000, 3000, 5000
Volume (ml/kg bw): 10, 20 - No. of animals per sex per dose:
- 5 per sex per dose
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 122 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: effect level in a range of 1656-2619 mg/kg bw
- Mortality:
- (1000 mg/kg bw) no deaths; (2000 mg/kg bw) 4 death; (3000 mg/kg bw) 9 death; (5000 mg/kg bw) all animals were found dead
- Clinical signs:
- Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested.
Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw.
Convultions were observed at the dose of 5000 mg/kg bw. - Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 (male/female) = 2122 mg/kg bw
- Executive summary:
Method
The test substance was tested for Acute Oral Toxicity on rats according to a method similar to the OECD Guideline 401. Five animals per sex per dose were administered by gavage with the test item at four different concentrations ( 1000, 2000, 3000 and 5000 mg/kg bw).
Observations
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages. Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.
During the test Sedation, Dyspnoea, Exophtalmos, Ruffled fur, Body Position (Curved) in all the concentration tested. Diarrhoea was observed at doses of 1000, 2000 and 3000 mg/kg bw. Convultions were observed at the dose of 5000 mg/kg bw.
At 1000 mg/kg bw no deaths occurred and at the maximum dose (5000 mg/kg bw) all the animals were found dead, at the other concentrations the following number of animals were found dead: 4 animals at 2000 mg/kg bw and 9 animals at 3000 mg/kg bw.
Conclusion
LD50 (male/female) = 2122 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 122 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No studies on "Acute Oral Toxicity" are available on the Target Substance in itself. However studies conducted on a Similar Substance have been used for the assessment.
The Target Substance and the Similar Substance 01 only differ on the salification. More information are reported in section 13.
The key study (Huntsman, 1978) was performed according to a method similar to OECD guideline 401, following oral administration of four doses to the rats (1000, 2000, 3000, 5000 mg/kg bw). At 1000 mg/kg bw no deaths occurred and at the maximum dose (5000 mg/kg bw) all the animals were found dead, at the other concentrations the following number of animals were found dead: 4 animals at 2000 mg/kg bw and 9 animals at 3000 mg/kg bw. The acute oral LD50 was determined to be 2122 mg/kg bw.
The supporting study (Huntsman, 1980) was performed according to a method similar to OECD guideline 401 and following administration administration of six doses to the rats (1000, 2200, 2500, 3000, 5000 mg/kg bw). At 1000 and 2000 mg/kg bw no deaths occurred and at the maximum doses (5000 and 3000 mg/kg bw) all the animals were found dead, at the other concentrations the following number of animals were found dead: 2 animals at 2200 mg/kg bw and 8 animals at 2500 mg/kg bw. The acute oral LD50 was determined to be 2343 mg/kg bw.
The values reported above are in line with the results obtained with further tests conducted with Similar Substance 01, where the LD50 was found to be in a range of 2710 – 7080 mg/kg bw. More details are reported in the file attached below.
LD50 (male/female) = 2122 mg/kg bw
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be 2122 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).
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