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EC number: 269-123-7 | CAS number: 68187-76-8
- 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
LD50 . oral > 15600 mg/kg
FLL sample 4, limit test, LD50 oral > 2000 mg/kg
FLL sample 4, LD50, dermal > 2000 mg/kg
acute toxicity inhalation: not relevant
The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.
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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good study, no GLP compliance.
- Qualifier:
- according to guideline
- Guideline:
- other: 67/548/CEE
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nossan Correzzana
- Weight at study initiation: 200 g
- Fasting period before study:last night before starting experiment, and 4 hours after dose administration
- Housing: 5 per cage in transparent polycarbonate cage 1290
- Diet: commercial pellet, ad libitum.
- Water: municipal filtered tap water,, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±1
- Humidity (%):55±15
- Air changes (per hr):8
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION : 1.5 mg/100gr bw
- Doses:
- 15600 mg/kg
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:before treatment
- Necropsy of survivors performed: yes
- Other examinations performed: gastro-intestinal tract, Peripheral nervous system, central nervous system, urine analisys, cardiovascular, respiratory, - Statistics:
- LD50 was calculated by Thompson-Weil method.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 15 600 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 600 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no motality observed
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on result (LD50>15600 mg/kg bw) the test item castol oil is considered as non toxic substance.
- Executive summary:
Castor oil sulphated sodium salt is administered by gavage on 10 wistar rats by method 67/548/ECC. Based on result (LD50>15600 mg/kg bw) the test item castol oil is considered as non toxic substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 600 mg/kg bw
- Quality of whole database:
- Quality of the database is not very high, but enough to assess acute toxicity of the substance
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
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The test performed in 1984 follows old guidelines but it is still representative of the substance toxicity. The other two studies submitted for acute oral toxicity, performed in 2010 in GLP, showed that this class of substance does not show any potential to be toxic after single exposure. Therefore, the test on the targte substance is considered valid and taken as key study. However for CAS calculations values of 2000 mg/kg are used, following a more conservative case.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are the following:
For oral exposure:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
For pure substance ATE can be estimated to be similar to LD50 that can be used for classification.
The LD50, oral of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by oral exposure.
For dermal exposure:
Category 1: ATE <= 50 mg/kg bw
Category 2: 50 < ATE <= 200 mg/kg bw
Category 3: 200 < ATE <= 1000 mg/kg bw
Category 4: 1000 < ATE <= 2000 mg/kg bw
The LD50, dermal of the test substance was determined to be > 2000 mg/kg bw and therefore, the test substance is not classified for Acute toxicity by dermal exposure.
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