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EC number: 225-591-4 | CAS number: 4948-28-1
- 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
In the key acute oral toxicity study in male and female rats, the LD50 was found to be 2050 mg/kg bw in male and females.
In a supporting acute oral toxicity study in male and female rats, all animals died at a single dose of 5000 mg/kg bw. The LD50 is thus <5000 mg/kg bw.
In an acute dermal toxicity study in male and female rabbits, all animals survived after a single dose of 5000 mg/kg bw. The LD50 is thus >5000 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:
- supporting study
- Study period:
- 1979-03-12 to 1979-05-31
- 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)
- Deviations:
- yes
- Remarks:
- See "Principles of method other than guideline"
- Principles of method if other than guideline:
- - Principle of test: Acute oral toxicity test in rats
- Short description of test conditions: A single oral treatment was given to 5 male and 5 female Wistar rats. Animals were observed for signs of toxicity for 14 days and then subjected to gross pathology. No detailed description of environmental conditions and clinical signs is available. Body weights were recorded at the beginning and after the 14-day observation period.
- Parameters analysed / observed: Mortality, gross pathology - GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both males and females were used
- Age at study initiation: Approx. 6-8 weeks
- Weight at study initiation: 192 - 258 g
- Fasting period before study: 18 hours
- Housing: In galvanized cages with indirect bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 2 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature-controlled room
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 15 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- The test article was used in 25% gravimetric suspension, warmed to liquification for dosing
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex were treated with a single dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter. Body weights were recorded at the beginning of the study and after the 14-day observation period.
- Necropsy of survivors performed: Yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable
- Remarks:
- Not determinable because of 100% mortality at a single dose of 5000 mg/kg bw
- Mortality:
- All male and female animals died at 5000 mg/kg bw:
2/5 males died within 3 hours after administration and 3/5 males within 6 hours after administration;
5/5 males died within 3 hours after administration - Clinical signs:
- other: Severe depression
- Gross pathology:
- The internal organs and superficial examination appeared normal
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In an acute oral toxicity study in male and female rats, all animals died at a single dose of 5000 mg/kg bw. The LD50 is thus <5000 mg/kg bw.
- Executive summary:
In a GLP compliant acute oral toxicity study in 5 male and 5 female albino rats, the test item was applied at a single dose of 5000 mg/kg bw in corn oil by oral administration. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. Severe depression was observed in all animals 1-3 hours after treatment. All animals died 6 hours after dosing by the latest. No gross pathological changes were observed. Thus the LD50 was found to be <5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-03-12 to 1979-05-31
- 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)
- Deviations:
- yes
- Remarks:
- See "Principles of method other than guideline"
- Principles of method if other than guideline:
- - Principle of test: Acute oral toxicity test in rats
- Short description of test conditions: Wistar rats were treated with different doses of the test item (5 males and 5 females per dose). Animals were observed for signs of toxicity for 14 days and then subjected to gross pathology. No detailed description of environmental conditions and clinical signs is available. Body weights were recorded at the beginning and after the 14-day observation period.
- Parameters analysed / observed: Mortality, gross pathology - GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both males and females were used
- Age at study initiation: Approx. 6-8 weeks
- Weight at study initiation: 184 - 278 g
- Fasting period before study: 18 hours
- Housing: In galvanized cages with indirect bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 2 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature-controlled room
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 15 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- The test article was used in 25% gravimetric suspension, warmed to liquification for dosing
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - Doses:
- 1260, 2000, 2520 and 3140 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter. Body weights were recorded at the beginning of the study and after the 14-day observation period.
- Necropsy of survivors performed: Yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 050 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 630 - < 2 580
- Mortality:
- 1260 mg/kg bw: 0/5 males and 2/5 females died
2000 mg/kg bw: 2/5 males and 3/5 females died
2520 mg/kg bw: 2/5 males and 4/5 females died
3140 mg/kg bw: 4/5 males and 3/5 females died - Clinical signs:
- other: Clinical signs consisted of slight and severe depression,
- Gross pathology:
- The superficial examination appeared normal. In one male animals of the 1260 mg/kg bw group, a lesion on the left lobe of the lung was observed and one female animal of the 1260 mg/kg bw group showed a distended, gas filled stomach. In one male animal of the 2520 mg/kg bw group, fibrous tissue encasing heart and lungs was observed.
- Conclusions:
- In an acute oral toxicity study in male and female rats, the LD50 was found to be 2050 mg/kg bw in male and females.
- Executive summary:
In a GLP compliant acute oral toxicity study in Wistar rats, the test item was applied at doses of 1260, 2000, 2520 and 3140 mg/kg bw to 5 males and 5 females per dose by oral administration. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Animals were weighted before start of the treatment and at day 14. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. From a dose of 1260 mg/kg bw (females) and 2000 mg/kg bw (males), slight to severe depression was observed in all animals in the first 24 hours. Body weight gain decreased with increasing doses. At 1260 mg/kg bw, 0/5 males and 2/5 females, at 2000 mg/kg bw, 2/5 males and 3/5 females, at 2520 mg/kg bw, 2/5 males and 4/5 females and at 3140 mg/kg bw, 4/5 males and 3/5 females died. Thus, the LD50 was found to be 2050 mg/kg bw for males and females.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 050 mg/kg bw
- Quality of whole database:
- Reliable with restrictions
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:
- 1979-03-12 to 1979-05-31
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- See "Principles of method other than guideline"
- Principles of method if other than guideline:
- - Principle of test: Acute dermal toxicity test in rabbits
- Short description of test conditions: A single dermal treatment was given to 3 male and 3 female albino rabbits. The skin of three rabbits was abraded, the remaining animal's skin remained intact. The test side was occluded for 24 hours. Animals were observed for sign of toxicity for 14 days and then subjected to gross pathology. No detailed description of environmental conditions, dose preparation, vehicle identity and clinical signs are available. Body weights were not recorded during the study. Times of death were not described.
- Parameters analysed / observed: Mortality, gross pathology - GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both males and females were used
- Age at study initiation: 3-4 months
- Weight at study initiation: 1.76 - 2.32 kg
- Housing: In galvanized cages with indirect bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature-controlled room
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 15 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test item was wiped off the skin after 24 hours
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- One single dose of 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals per sex were treated with a single dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter. Body weights were recorded at the beginning of the study and after the 14-day observation period.
- Necropsy of survivors performed: Yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None of the animals died within the treatment and post-treatment period.
- Clinical signs:
- other: No clinical signs observed
- Gross pathology:
- The internal organs and superficial examination appeared normal.
- Other findings:
- In two male animals with abraded skin, small scab has formed and detached.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study in male and female rabbits, all animals survived after a single dose of 5000 mg/kg bw. The LD50 is thus >5000 mg/kg bw.
- Executive summary:
In a GLP compliant acute dermal toxicity study in 3 male and 3 female New Zealand white rabbits, the test item was applied at a single dose of 5000 mg/kg bw by occlusive administration to abraded (2 males and 1 female) and non-abraded (1 male, 2 females) skin. The test side was occluded for 24 hours. After the treatment period, the occlusive wrap and all remaining test item was removed. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. No deaths, clinical signs or changes in body weight gain were observed. Thus, the LD50 was found to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
- Quality of whole database:
- Reliable with restrictions
Additional information
Acute oral toxicity, rat, RL2, key study
In an GLP compliant acute oral toxicity study in Wistar rats, the test item was applied at doses of 1260, 2000, 2520 and 3140 mg/kg bw to 5 males and 5 females per dose by oral administration. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Animals were weighted before start of the treatment and at day 14. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. From a dose of 1260 mg/kg bw (females) and 2000 mg/kg bw (males), slight to severe depression was observed in all animals in the first 24 hours. Body weight gain decreased with increasing doses. At 1260 mg/kg bw, 0/5 males and 2/5 females, at 2000 mg/kg bw, 2/5 males and 3/5 females, at 2520 mg/kg bw, 2/5 males and 4/5 females and at 3140 mg/kg bw, 4/5 males and 3/5 females died. Thus, the LD50 was found to be 2050 mg/kg bw for males and females.
Acute oral toxicity, rat, RL2, supporting study
In an GLP compliant acute oral toxicity study in 5 male and 5 female albino rats, the test item was applied at a single dose of 5000 mg/kg bw in corn oil by oral administration. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. Severe depression was observed in all animals 1-3 hours after treatment. All animals died 6 hours after dosing by the latest. No gross pathological changes were observed. Thus the LD50 was found to be <5000 mg/kg bw.
Acute dermal toxicity, rat, RL2, key study
In a GLP compliant acute dermal toxicity study in 3 male and 3 female New Zealand white rabbits, the test item was applied at a single dose of 5000 mg/kg bw by occlusive administration to abraded (2 males and 1 female) and non-abraded (1 male, 2 females) skin. The test side was occluded for 24 hours. After the treatment period, the occlusive wrap and all remaining test item was removed. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. No deaths, clinical signs or changes in body weight gain were observed. Thus, the LD50 was found to be >5000 mg/kg bw.
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 oral and dermal toxicity, the test item is not classified and labelled for acute toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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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