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Diss Factsheets
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EC number: 916-632-3 | 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
Three studies differing in the route of exposure were performed to investigate the acute toxicity of the test item in male rats:
Key_acute oral_1973_Sandoz_13/73
Sup_acute dermal_1973_Sandoz_73/73
Sup_intraperitoneal_1973_Sandoz_73/73
Although each of these tests is poorly documented in terms of e.g. test design and details on test animals, the set in its entirety fulfills all requirements of a fully valid study thus allowing the conclusion that the test item exerts no acute toxicity.
Justification for selection of acute
toxicity endpoint
No single study was selected
because in view of different shortcomings in all available studies
preference is given to the entirety of all available studies in order to
get a fully valid data set.
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- poor documentation
- Qualifier:
- no guideline followed
- Version / remarks:
- Study pre-dates creation of guidelines, but a method similar to OECD 401 is likely
- Principles of method if other than guideline:
- Treatment of rats via gavage with subsequent observation
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- dionized
- Details on oral exposure:
- - Concentration in vehicle: ca. 33 %
- Amount of vehicle (if gavage): 15 mL per kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: none reported
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) no 1272/2008
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008. - Executive summary:
In a pre-guideline study the acute oral toxicity was investigated in white male rats.
The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The study is poorly documentd but the findings and conclusions are sufficiently supported by consideration of oral, dermal and intrapertoneal studies, which all show no adverse efffects even after intraperitoneal injection.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- poor documentation
- Qualifier:
- no guideline followed
- Version / remarks:
- study pre-dates creation of guidelines but a method similar to OECD TG 402 is likely
- Principles of method if other than guideline:
- 4 hours dermal treatment with subsequent observation
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 260 - 280 g (mean 270 g)
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: gauze patch, covered with plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- For solids, paste formed: moistened with propylene glycol - Duration of exposure:
- 4 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 4 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: after 4 hours, 2, 6, 9, 13 and 14 days
- Frequency of weighing: after 2, 6, 9, 13, 14 days - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: at the first two readings after 4 hours and 2 days the treated skin was discoloured by the test material. In addition, reddened skin was noted in 2 animals.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) No. 1272/2008
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008. - Executive summary:
In a pre-guideline study the acute dermal toxicity was investigated in 4 male rats.
In a limit test the acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
In a further study the test material was administered by the intraperitoneal route. The determined LD50 was greater than 5000 mg/kg bw. No adverse effects at all were reported after i.p. injection.
Justification for classification or non-classification
For all routes of exposure - oral, dermal and intraperitoneal - the determined median lethal dose is greater than 5000 mg/kg bw.
Thus, the test item has not to be classified for acute toxicity according to Regulation (EC) no 1272/2008.
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