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EC number: 432-550-6 | CAS number: 243858-01-7
- 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
The test substance is considered to be of low acute (oral and dermal) toxicity with LD50 values >2,000 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:
- key study
- Study period:
- From June 29, 1999 to July 13, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HSD: Sprague Dawley SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 33178 Borchen, SPF breeding colony.
- Age at study initiation: 6-10 weeks
- Body weight range at treatment: Males: 192-204 g; Females: 182-192 g
- Housing: In fully air-conditioned rooms in macrolon cages (i.e., type 4) on soft wood granulate in groups of 5 animals
- Diet: Ssnif R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
- Animal identification: Fur marking with KMnO4 and cage numbering
- Randomization procedure: Randomization schemes 98.0691, 98.0690
- Withdrawal of food: From about 16 h before to 3-4 h after treatment
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: June 29, 1999 to July 13, 1999 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension in deionized water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
PREPARATION OF THE TEST SUBSTANCE: Test substance was suspended 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 - Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- not specified
- 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. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: Irregular respiration, diarrhea and orange discolored feces were observed after the administration of test substance.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the oral LD50 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 rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP.
Groups of five female and five male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% suspension of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.
No mortality occurred, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Irregular respiration, diarrhea and orange discolored feces were observed after the administration of the test substance.
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- 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
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Aug. 11, 1999 to Aug. 25, 1999
- 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
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: No adverse effect observed. All animals had an orange discolouration of the skin upto 6 d. In some animals this lasted upto 12 d.
- Gross pathology:
- No macroscopically visible changes were seen.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg bw.
- Executive summary:
A study was performed to assess the acute dermal toxicity of the test substance in Sprague Dawley rats according to the OECD Guideline 402 and EU method B.3 in compliance with GLP.
A group of rats (5 per sex) was exposed at the dose of 2000 mg/kg bw. Exposure lasted 24 h. Animals were observed for clinical signs, signs of irritation and body weight changes over a period of 14 d.
No clinical signs were observed. All animals had an orange discolouration of the skin upto 6 d. In some animals this lasted upto 12 d. No treatment related effect on body weight gain was observed. Gross pathological examination did not reveal any macroscopic abnormalities.
Under the test conditions, the acute oral LD50 of the test substance for male and females rats was determined > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality study.
Additional information
Oral route:
A study was conducted to assess the acute oral toxicity of the test substance inHSD: Sprague Dawley rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP. Group of five female and five male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% suspension of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw. No mortality occurred, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Irregular respiration, diarrhea and orange discolored feces were observed after the administration of the test substance. Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats (Roth, 1999).
Dermal route:
A study was performed to assess the acute dermal toxicity of the test substance in Sprague Dawley rats according to the OECD Guideline 402 and EU method B.3, in compliance with GLP. A group of rats (5 per sex) was exposed at the dose of 2,000 mg/kg bw. Exposure lasted 24 h. Animals were observed for clinical signs, signs of irritation and body weight changes over a period of 14 d. No clinical signs were recorded. All animals had an orange discolouration of the skin up to 6 d. In some animals this lasted up to 12 d. No treatment related effect on body weight gain was observed. Gross pathological examination did not reveal any macroscopic abnormalities. Under the test conditions, the acute oral LD50 of the test substance for male and females rats was determined > 2,000 mg/kg bw (Seeberger, 1999).
Justification for classification or non-classification
Oral route:
Based on the results of an acute oral toxicity study, the test substance does not need to be classified for acute toxicity according to the EU CLP criteria (EC 1272/2008) as well as EU Directive 67/548/EEC.
Dermal route:
Based on the results of an acute dermal toxicity study, the test substance does not need to be classified for acute toxicity according to the EU CLP criteria (EC 1272/2008) as well as EU Directive 67/548/EEC.
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