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EC number: 245-010-8 | CAS number: 22457-23-4
- 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 and dermal studies shown to be above limits for classification
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- there are no details on the method followed
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Sample Marking: 76-362, Stemone
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2.05 g/Kg
3.2 g/Kg
5.0 g/Kg
6.25 g/Kg - No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 870 - <= 5 010
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg, therefore not classified for CLP
- Executive summary:
An acute oral study was carried out on rats in high doses (>2000mg/Kg). The LD50 was determined to be 3.2 g/Kg, this is well above the category 4 classification limit of 2000 mg/Kg for CLP.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- oral gavage of varying quantities of material
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CFE ( now Crl-OFA(SD) )
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carworth
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: 18 hours
- Housing: raised wire mesh cages
- Diet: Fox Blox - ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: substance applied neat, no vehicle used.
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg - Doses:
- 1.0, 2.5, 3.0, 3.5, 4.0, 5.0 ml/Kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: no data - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3.5 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.78 - <= 4.41
- Mortality:
- See table below, observations at the 2.5 ml/Kg concentration and above. No deaths were observed at the lowest concentraton of 1 ml/kg
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Given the density of the material, the LD50 of 3.5ml/Kg bw will be above the lowest classification criteria for CLP, therefore according to this data, the substance should not be considered acutely toxic via the oral route.
- Executive summary:
Sixty normal, healthy, female Carworth rats were fasted for eighteen hours prior to dosing. The test material was administered orally, by rigid stomach tube, at several dose levels to groups of ten rats. No deaths were observed at the lowest dose level of 1.0 ml/Kg bw, the oral LD₅₀ was calculated to be 3.5 ml/Kg bw for female rats. Given the density of the material, the oral LD₅₀ of 3.5ml/Kg bw will be above the lowest classification criteria for CLP, therefore according to this data, the substance should not be considered actutely toxic via the oral route.
Referenceopen allclose all
Dose (g/Kg) | Deaths / No. of Anmials | Observation Day | |||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2.05 | 1/10 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3.2 | 5/10 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5.0 | 8/10 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6.25 | 7/10 | 2 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Symptomatology
2.05 g/kg - lethargy, piloerection, flaccid;
3.2 g/kg -ataxia, lethargy, ptosis;
5.0 g/kg ataxia, loss of righting reflex;
6.25 g/kg - ataxia, lethargy, ptosis, piloerection
Necropsy | 2.05 g/kg | 3.2 g/kg | 5.0 g/kg | 6.25 g/kg |
Liver blotchy | 1 | 5 | 2 | 6 |
Lungs dark | 0 | 4 | 8 | 7 |
Small intestine very red | 0 | 3 | 5 | 2 |
blood around nose, mouth and eye | 0 | 3 | 0 | 3 |
bloody urine | 1 | 0 | 0 | 0 |
Results:
Dose (ml/kg) |
Response | % Observed |
% Expected |
Observed Minimus Expected |
(CHI)² |
1.0 | 0/10 | 0 /10 | 0.46 | 0.46 | |
2.5 | 3/10 | 30 | 28 | 2 | 0.0019 |
3.0 |
4/10 | 40 | 40 | 0 | -- |
3.5 | 5/10 | 50 | 50 | 0 | -- |
4.0 | 6/10 | 60 | 60 | 0 | -- |
5.0 | 9/10 | 90 | 75 | 15 | 0.1180 |
1.19 |
ED₈₄= 6.0
ED₅₀= 3.5
ED₁₆= 1.98
N¹ = 40
S = [(ED₈₄/ ED₅₀) + (ED₅₀/ ED₁₆)] / 2 = 1.741
fED₅₀= S²·⁷⁷/√N¹= 1.26
ED₅₀ x fED₅₀= 4.41
ED₅₀ / fED₅₀= 2.78
The oral LD50 was calculated to be 3.5 ml/Kg bw for female rats with a 19/20 confidence limit of 2.78 - 4.41 ml/Kg bw
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 200 mg/kg bw
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no details on the method are available.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Sample Marking: 76-362, Stemone
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 14 d
- Doses:
- 2.5 g/kg
5.0 g/kg - No. of animals per sex per dose:
- 4 @ 2.5 g/kg
8 @ 5 g/kg - Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 shown to be above 5000 mg/kg.
- Executive summary:
An acute dermal toxicity study was carried out on Rabbits, the LD 50 was determined to be greater than the highest test dose of 5000 mg/kg, therefore the substance can be considered as not classified according to CLP criteria.
Reference
Dose (g/Kg) | Deaths / No. of Anmials | Observation Day | |||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2.5 | 0/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5.0 | 2/8 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Slight redness in 1 at 5.0 g/kg
Moderate redness in others
Slight edema in 2 at 2.5 g/kg and 2 at 5.0 g/kg
Moderate edema in others
Necropsy - portion of small intestine reddened and evidence of diarrhea prior to death in 1.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Justification for classification or non-classification
Two oral studies have shown the LD50 oral for Stemone to be greater than 2000mg/Kg, a dermal study showed that the LD50 was above 5000mg/kg, therefore it should be considered not classified for CLP for acute toxicity endpoints.
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