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EC number: 443-090-0 | 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
No deaths or adverse effects were observed in the acute oral or dermal toxicity study in rats.
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:
- From October 24, 2001 to November 08, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males: mean=199 g (=100%) (S.D.=±11.5 g); female animals: mean=180 g (= 100%) (S.D.=±7.5 g)
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: ssniff® R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 d
-Animal identification: fur marking with KMnO4 and cage numbering
-Randomization procedure: Computer generated algorithm (archived with raw data) randomization schemes 2001.0529, 2001.0530
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: October 24, 2001 to November 08, 2001 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% solution in deionized water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION :Test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test (according to toxicity data of related compounds)
-Duration of treatment: single dose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Test Procedure:
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 d. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No symptoms were observed in male animals. Few clinical signs stilted gait and yellowish discoloured urine were observed after the administration of the test substance in female animals. However, from 2 d until the end of the study no symptoms were obser
- Gross pathology:
- The animals killed at the end of observation period showed no macroscopically visible changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the oral LD50 of the test substance was found to be >2,000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP.
Group of three female and three male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% solution of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.
No mortality occurred, no clinical signs were observed in male and no significant macroscopic abnormalities were seen at necropsy. Stilted gait and yellowish discolored urine were observed after the administration of test substance in female animals. However, there were no symptoms in female rats from Day 2 until the end of the study.
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study.
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:
- key study
- Study period:
- From October 31, 2001 to November 14, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males: mean=262 g (=100%) (S.D.=±12.6 g); female animals: mean=210 g (=100%) (S.D.=±12.2 g)
- Housing: in transparent macrolon® cages (type III) on soft wood granulate in an air-conditioned room, 1 animal per cage
- Diet: ssniff® R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 7 d
-Animal identification: cage numbering
Randomization procedure: Computer generated algorithm (archived with raw data) randomization schemes 2001.0529, 2001.0530
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: October 31, 2001 to November 14, 2001 - Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- moistened with deionized water to form a paste
- Details on dermal exposure:
- Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm².
The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width, both manufactured by Beiersdorf Aktiengesellschaft). At the end of the dermal exposure period of 24 h the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- The observation period after the dermal administration lasted for 14 d.
Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of test substance. The skin of four animals showed slight erythema from Day 2 to Day 5 of the study. However, the skin of the other animals showed no signs of irritation.
- Gross pathology:
- The animals killed at the end of observation period showed no macroscopically visible changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the dermal LD50 of the test substance was found to be > 2,000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423, EU Method B.1. and EPA OPPTS 870.1200, in compliance with GLP.
Groups of five female and five male rats received a single dermal dose of 2,000 mg/kg bw. 500 mg of test substance moistened with 0.4 mL deionized water was applied topically under occlusive conditions for 24 h.
No mortality occurred, no clinical signs were observed and no significant macroscopic abnormalities were seen at necropsy. Body weight was also not impaired. Only one female showed a very slight loss of weight between Days 1 and 8. However, the body weight gain returned to normal by end of the study (15 d). Although the skin of four animals showed slight erythema from Days 2 to 5 of the study, no signs of irritation were observed in the rest of the animals.
Under the study conditions, the dermal LD50 of the test substance was found to be > 2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study.
Additional information
A study was conducted to assess the acute oral toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423 and EU Method B.1, in compliance with GLP. Group of three female and three male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% solution of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw. No mortality occurred, no clinical signs were observed in male and no significant macroscopic abnormalities were seen at necropsy. Stilted gait and yellowish discolored urine were observed after the administration of test substance in female animals. However, there were no symptoms in female rats from Day 2 until the end of the study. Under the study conditions, the oral LD50 was found to be > 2,000 mg/kg bw in rats.
No acute inhalation toxicity study was conducted as exposure via this route is not to be expected.The test substance has a very low vapour pressure and a high melting point and is hence not volatile. Test item synthesis and spray drying is performed in a closed process and the dedusting agents are mixed directly with the wet press cake. Consequently, the final product consists of non-dusty granules or well de-dusted powders and the potential for the generation of inhalable forms is low. In addition the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route is unlikely to occur.
A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague Dawley (SD) rats according to OECD Guideline 423, EU Method B.1. and EPA OPPTS 870.1200, in compliance with GLP. Groups of five female and five male rats received a single dermal dose of 2,000 mg/kg bw. 500 mg of test substance moistened with 0.4 mL deionized water was applied topically under occlusive conditions for 24 h. No mortality occurred, no clinical signs were observed and no significant macroscopic abnormalities were seen at necropsy. Body weight was also not impaired. Only one female showed a very slight loss of weight between Days 1 and 8. However, the body weight gain returned to normal by end of the study (15 d). Although the skin of four animals showed slight erythema from Days 2 to 5 of the study, no signs of irritation were observed in the rest of the animals. Under the study conditions, the dermal LD50 of the test substance was found to be > 2,000 mg/kg bw in rats.
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.
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