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EC number: 684-597-9 | CAS number: 1072005-10-7
- 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
No data on the test item is available. With the read-across substances the following results were obtained:
Acute oral, mouse (CAS 68583-51-7): EC50 > 4600 mg/kg
Acute inhalation, guinea pig (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³)
Acute inhalation, rat (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³)
Acute dermal, rat (CAS 853947-59-8): LD50 > 2000 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:
- May 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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:
- mouse
- Strain:
- other: White mice of Tylers original strain
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20 ± 2 g
- Fasting period before study: overnight
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no details available - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No details available
- Doses:
- 5 mL/kg, which is correspondent to 4.6 mg/kg bw
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: after 1, 2, 3, 4, 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: no - Preliminary study:
- Pretest: Concentrations: 1, 2, 3, 4 and 5 mL/kg, 2 animals each, observed for 7 days, no deaths observed
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 600 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the test item in mice was established as exceeding 4600 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, conducted similar to OECD 401, groups of fasted white mice were given a single oral dose of the test item at a dose of 5 mL/kg bw and observed for 14 days. No animals died during the study. No clinical signs were observed during the study period. The oral LD50 was determined to be > 5 mL/kg bw, which is correspondent to 4600 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 600 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 4 600 mg/kg bw
- Quality of whole database:
- similar to guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: young
- Weight at study initiation: 285 - 465 g - Route of administration:
- inhalation: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Each group of guinea pigs was placed in a 75 liter chamber equipped with an air supply of 10 liters per minute. After the test animals became accustomed to the chamber conditions, the test item was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm. Particle counts were performed every 30 minutes using Bausch and Lomb particle counter (model 40-1A). The chamber temperature was recorded every 30 minutes. The control group was exposed to only air for the same length of time.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Concentrations:
- 200 ppm (equivalent to 5952 mg/m³)
- No. of animals per sex per dose:
- 200 ppm: 6 male, 6 female
control: 3 animals - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Mortality:
- No animals died or were sacrificed in moribund condition.
- Clinical signs:
- other: No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period.
- Gross pathology:
- In the necropsies and microscopic examination no changes in the animals were detected, which could be related to the treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute inhalation study on guinea pigs over 6h the LC50 was above 200 ppm (equivalent to 5952 mg/m³):
- Executive summary:
An acute inhalation study on guinea pigs over 6h with the test item was performed. The concentration of 200 ppm was prayed into the air supply for 12 guinea pigs (6 male, 6 female). After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, New York
- Age at study initiation: young
- Weight at study initiation: 145 - 195 g - Route of administration:
- inhalation: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Each group of rats was placed in a 75 liter chamber equipped with an air supply of 10 liters per minute. After the test animals became accustomed to the chamber conditions, the test item was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm. Particle counts were performed every 30 minutes using Bausch and Lomb particle counter (model 40-1A). The chamber temperature was recorded every 30 minutes. The control group was exposed to only air for the same length of time.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Concentrations:
- 200 ppm (equivalent to 5952 mg/m³)
- No. of animals per sex per dose:
- 200 ppm: 10 male
control: 3 male - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes - Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Sex:
- male
- Dose descriptor:
- discriminating conc.
- Effect level:
- 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Mortality:
- No animals died or were sacrificed in moribund condition.
- Clinical signs:
- other: No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period.
- Gross pathology:
- In the necropsies and microscopic examination no changes in the animals were detected, which could be related to the treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute inhalation study on rats over 6h the LC50 was above 200 ppm (equivalent to 5952 mg/m³).
- Executive summary:
An acute inhalation study on rats over 6h with the test item was performed. The concentration of 200 ppm was sprayed into the air supply for 10 male Sprague-Dawley rats. After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Chaper 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Sex:
- male
- Dose descriptor:
- discriminating conc.
- Effect level:
- 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 200 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: equivalent to 5952 mg/m³
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 952 mg/m³ air
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:
- December 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Updated Guideline adopted February 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, D-W-4799 Borchen
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no
- Housing: Singly in type III Makrolon cages
- Diet: ad libitum, Ssniff R 10 complete feed for rats, supplied by Ssniff Spezialfutter GmbH, D-W-4770 Soest
- Water: Drinking water ad libitum, supplied by Gelsenwasser, waterworks, D-W-4358 Haltern
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70%
- Photoperiod: Artificial light, 12-hour light/dark rhythm - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap: mull patch
REMOVAL OF TEST SUBSTANCE
- Washing: no
TEST MATERIAL
- Amount applied: 2.2 cm3/kg bodyweigh - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: after 1/2, 1, 2, 3, 4, 5 and 6 hours and once a day for the next two weeks
- Frequency of weighting: day 0, 7 and 14
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No signs of toxicity related to the test substance were found during the 14-day observation period. The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.
- Gross pathology:
- The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity test according to OECD 402 with male and female rats determined a LD50 > 2000 mg/kg bw.
- Executive summary:
The test of the acute dermal toxicity of the test item for male and female rats with undiluted test substance in a limit test with a dose of 2000 mg/kg bodyweight according to OECD 402 was conducted. The volume administered was 2.2 cm3/kg bodyweight. Five male and five female animals showed normal bodyweight change during the 14-day observation period. No signs of toxicity related to the substance occurred either in the males or in the females. Necropsy at the end of the test showed no evidence of macroscopic changes to organs of any of the animals. The median lethal dose (LD5O) found in the limit test for acute dermal toxicity in rats was 2000 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline study
Additional information
No data on the test item is available. With the read-across substances the following results were obtained:
In an acute oral toxicity study, conducted similar to OECD 401, groups of fasted white mice were given a single oral dose of the read across substance CAS 68583-51-7 at a dose of 5 mL/kg bw and observed for 14 days. No animals died during the study. No clinical signs were observed during the study period. The oral LD50 was determined to be > 5 mL/kg bw, which is correspondent to 4600 mg/kg bw.
An acute inhalation study on guinea pigs over 6h with the read across substance CAS 68583-51-7 was performed. The concentration of 200 ppm was prayed into the air supply for 12 guinea pigs (6 male, 6 female). After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).
An acute inhalation study on rats over 6h with the read across substance CAS 68583-51-7 was performed. The concentration of 200 ppm was sprayed into the air supply for 10 male Sprague-Dawley rats. After the exposure of 6h, the animals were observed daily for a period of 7 days and their appearance and behavior was noted. At the completion of the observation period a gross necropsy was performed, all major tissues and organs were preserved and the lungs and all grossly abnormal organs were examined microscopically. The 6 hour inhalation produced no pathologic changes in the animals which could be related to treatment. No abnormal observations were made on the animals immediately after exposure or during the 7 day observation period. No animals died or were sacrificed in moribund condition. Therefore the discriminating dose is 200 ppm, the LC50 > 200ppm (equivalent to 5952 mg/m³).
The test of the acute dermal toxicity of the read across substance CAS 853947-59-8 for male and female rats with undiluted test substance in a limit test with a dose of 2000 mg/kg bodyweight according to OECD 402 was conducted. The volume administered was 2.2 cm3/kg bodyweight. Five male and five female animals showed normal bodyweight change during the 14-day observation period. No signs of toxicity related to the substance occurred either in the males or in the females. Necropsy at the end of the test showed no evidence of macroscopic changes to organs of any of the animals. The median lethal dose (LD5O) found in the limit test for acute dermal toxicity in rats was 2000 mg/kg bw.
Based on the results of the read across susbtances the test item is not acute toxic.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is classified and labelled as not acute toxic according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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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