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EC number: 224-546-6 | CAS number: 4403-90-1
- 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
The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 5000 mg/kg bw.
RA - The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 15000 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- November 22, 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The test was conducted according to an Internal Method. No other information is available.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150 - 200 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg bw
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 5000 mg/kg bw.
- Executive summary:
Method:
The Acute Oral Toxicity was determined with an internal standard procedure
Result:
LD50 > 5000 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- July 25, 1973
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 95 and 105 g.
- Fasting period before study: fasted overnight before treatment
- Housing: housed in groups of 5 in macrolon cages
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Air changes (per hr): Photoperiod (hrs dark / hrs light): 14 hours light/day - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 15000 mg/kg bw (only this dose is reported)
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 8 days
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The Acute Oral Toxicity was determined with an internal standard procedure. The test substance has a LD50 > 15000 mg/kg bw.
- Executive summary:
Method:
The Acute Oral Toxicity was determined with an internal standard procedure.
Conclusion:
LD50 > 15000 mg/kg bw.
Referenceopen allclose all
Under these experimental conditions, the test item was practically devoid of toxicity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 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
Only a short abstract on the "Acute Oral Toxicity" is available for the substance in itself, which doesn’t give enough information for a complete assessment.
Nevertheless another study, which support the result obtained in the above mentioned test, was conducted on an analogue substance. Further information are reported in the Read Across justification attached to section 13.
The first study was performed according to an internal method, whose details are unknown, following oral administration of a single dose of 5000 mg/Kg bw. The LD50 was > 5000 mg/kg bw.
The second study, conducted on the Similar Substance 01, was performed according to an internal procedure, following administration of a multiple doses. Also for this study only a short summary is available. The acute oral LD50 was determined to be > 15000 mg/kg bw.
Considering both the studies on the substance in itself and on the Similar Substance, the effect level is considered to be greater than 500 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 > 5000 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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