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EC number: 701-365-5 | 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
Based on the available data it can be concluded that the test substance is not toxic by oral route.
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:
- 06 to 20 March 1980
- 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)
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 208 to 222 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: groups caging
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -
IN-LIFE DATES: From: 06. Mar To: 20. Mar 1980 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs: al least daily; body weight: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- -
- Preliminary study:
- NA
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: drowsiness, piloerection, diarrhea within 1 to 3 hours after dosing. Dark bluish discoloration of skin, feces and urine within 3 to 24 hours after dosing. Discolored skin and urine were observed during the entire observation period with decreasing intensi
- Gross pathology:
- slight bluish discoloration of cutis and subcutis, purple discolored kidneys;
- Interpretation of results:
- practically nontoxic
- Remarks:
- Criteria used for interpretation of results: Spector, Handbook of Toxicology
- Conclusions:
- LD50 above 5000 mg/kg bw. No classification required.
- Executive summary:
10 female rats were exposed to the test substance via oral gavage at a single concentrations of 5000 mg/kg body weight and observed for 14 days.
No mortality and adverse clinical signs were observed. No effects on body weight and in gross pathology slight bluish discoloration of cutis and subcutis, purple discolored kidneys observed. Drowsiness, piloerection, diarrhea within 1 to 3 hours after dosing. Dark bluish discoloration of skin, feces and urine within 3 to 24 hours after dosing, and discolored skin and urine were observed during the entire observation period with decreasing intensity.
Based on the observation the acute oral medial lethal dose of test substance is determined to be above 5000 mg/kg bw in female rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 to 26 October 1981
- 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)
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 214 to 232 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: group-caging (10/cage)
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -
IN-LIFE DATES: From: 12. Oct To: 26. Oct 1981 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs: at least daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- NA
- Preliminary study:
- NA
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no effects
- Gross pathology:
- no effects
- Other findings:
- bluish discoloration of skin and eyes within 1 hour after dosing; excretion of dye via feces and urine. All discolorations were reversible.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Criteria used for interpretation of results: other: Spector, Handbook of Toxicology
- Conclusions:
- LD50 above 5000 mg/kg bw. No classification required.
- Executive summary:
10 female rats were exposed to the test substance via oral gavage at a single concentrations of 5000 mg/kg body weight and observed for 14 days.
No mortality and adverse clinical signs were observed. No effects on body weight and in gross pathology were observed. Bluish discoloration of skin and eyes within 1 hour after dosing; excretion of dye via feces and urine were noted. All discolorations were reversible
Based on the observation the acute oral medial lethal dose of test substance is determined to be above 5000 mg/kg bw in female rats.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Comparable to guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- 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
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Single dose studies with oral gavage of the test item at doses up to 15000 mg/kg body weight are available. These studies showed that the test item has a very low toxicity with an oral LD50 between 14000 and 14500 mg/kg body weight. It is therefore scientifically not justified to perform an additional acute toxicity study with dermal application.
Due to the physico-chemical properties of the test item, dermal penetration is most unlikely. Due to the good water solubility, the toxicologically most relevant route of exposure is the oral one.
Inhalative exposure of workers to the test item is very unlikely, as production and spray drying is done in a closed process without isolation of reaction products. The isolated products are dust free granules (non-dusty solid) or liquid formulations, therefore, inhalative exposure of down-stream users is very unlikely, too.
Justification for selection of acute toxicity – oral endpoint
Detailed study conducted according to guideline.
Justification for selection of acute toxicity – inhalation endpoint
Data waiving: Exposure considerations
Production and spray drying is in closed process without isolation of
reaction products. Isolated product is in form of dust free granules
(non-dusty solid).
Justification for selection of acute toxicity – dermal endpoint
Study scientifically unjustified
Due to the physico-chemical properties of the test item, dermal
penetration is most unlikely. Due to the good water solubility, the
toxicologically most relevant route of exposure is the oral one. Single
dose studies with oral gavage of the test substance at doses up to 15000
mg/kg body weight are available. These studies showed that the test item
has a very low toxicity with an oral LD50 between 14000 and 14500 mg/kg
body weight (based on test material).
Justification for classification or non-classification
Based on the above stated assessment of the acute oral toxicity the substance does not need to be classified for acute oral toxicity according to GLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.
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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