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EC number: 230-907-9 | CAS number: 7365-45-9
- 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
Oral (OECD TG 423), rat: LD50 > 2000 mg/kg bw (reference 7.2.1 -1)
Dermal (OECD TG 402), rat: LD50 > 2000 mg/kg bw (reference 7.2.3 -1).
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:
- Jul 17 - Aug 28, 2000
- 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)
- Version / remarks:
- March 22, 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- September 30, 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 172 (range from 159 to 184) g
- Fasting period before study: 17 hours before dosing
- Housing: separately in Makrolon cages type III with a shelter, placed on mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 54 to 71
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 14 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: low toxicity, good solubility
- Purity: Aqua pro injectione
CLASS METHOD
- Rationale for the selection of the starting dose: limit dose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Standard statistical methods have been applied for data processing.
- 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:
- All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment.
- Gross pathology:
- No alterations were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of this study the test material is not acute toxic, i.e. the LD50 value is expected to exceed 2000 mg/kg bw.
- Executive summary:
The GLP study was performed according to OECD TG 423. The test material was tested for acute toxicity in Wistar rats (3/sex/dose) after oral administration of. A limit dose of 2000 mg/kg body weight was applied. Directly before the administration the test material was prepared with aqua pro injectione as vehicle. The animals were observed for 14 days.
All rats survived the observation period. No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw. The body weight development was normal. Gross pathology showed no alterations.
According to the results of this study the test material is not acute toxic, i.e. the LD50 value is expected to exceed 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study according to OECD TG, RL1.
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:
- Aug 2002 - Dec 2002
- 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:
- 24th February 1987
- Deviations:
- yes
- Remarks:
- animal room temperature outside range --> no effect on study outcome
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31st July 1992
- Deviations:
- yes
- Remarks:
- animal room temperature outside range --> no effect on study outcome
- 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: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: mean body weight ± standard deviation of 284 ± 9 g for the males and 230 ± 10 g for the females
- Housing:
During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the total body surface
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
No residual test item was observed on removal of the dressing.
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no - 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:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination of the main organs - Statistics:
- not applicable as no effects observed
- 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:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No apparent abnormalities were observed at necropsy in any animal.
- Other findings:
- No cutaneous reactions were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP-study according to OECD Test Guideline 402, the test item tested at 2000 mg/kg bw did not induce any mortality. Therefore, the respective LD50 is larger than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test item was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females). The application was performed with the test item in its original form at the dose of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy. The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations). No clinical signs and no deaths were observed during the study. A reduced weight gain was seen in all males and in 3/5 females between day 1 and day 8. The body weight gain of the other females was similar to historical control animals. No cutaneous reactions were observed. No apparent abnormalities were observed at necropsy in any animal. Under our experimental conditions, the dermal LD50 of the test item is higher than 2000 mg/kg in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study according to OECD TG, RL1.
Additional information
Acute toxicity: oral
The acute oral toxicity of 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid was assessed in a study performed according to the acute toxic class method ATC (OECD 423) in Wistar rats (3/sex/dose) (reference 7.2.1 -1). A limit dose of 2000 mg/kg bw was administered. All rats survived the observation period (14 days). No signs of toxicity were detected in the 3 male and 3 female rats after treatment. The body weight development was normal. Gross pathology showed no alterations. According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg bw.
Acute toxicity: dermal
In a study performed according to OECD 402, 2000 mg/kg bw the test item was applied to the shaved skin of 10 Sprague-Dawley rats (5/sex) and held under a semi-occlusive dressing for 24 hours (reference 7.2.3 -1). No clinical signs and no deaths were observed during the study. A reduced weight gain was seen in all males and in 3/5 females between day 1 and day 8. The body weight gain of the other females was similar to historical control animals. No cutaneous reactions were observed. No apparent abnormalities were observed at necropsy in any animal. The LD50 is considered to be > 2000 mg/kg bw.
The test substance-related findings were comparable for oral and dermal routes of application in the acute toxicity studies, with the high LD50-values indicating that the test item has a very low potential to cause acute toxicity via these routes.
Justification for classification or non-classification
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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