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EC number: 855-027-8 | CAS number: 2409921-75-9
- 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
Acute toxicity: via oral route
The LD50 of CR SB33 was greater than 2000 mg/kg B.W. (OECD TG423).
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:
- From January 4, 2019 to September 16, 2019
- 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)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: 8~12 week old
- Housing: two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Frequency of ventilation: 10~15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- Three
- Details on study design:
- 1. Test article was prepared to aqueous solution of 200 mg/mL in RO water. The dosage was 2,000 mg/kg BW.
2. After fasted overnight, the test article was administered in a single dose by gavage using a stomach tube.
3. First, three rats at group 1 were administered and observed for 48 hours. Group 2 were administered depending on the mortality results in the group 1.
3.1 If group 1 has <=1 out of three rats die, the same dose is administered to three rats in group 2 and their mortality rate is observed again.
3.2 If group 1 has >1 out of three rats die, a smaller dose is administered to three rats in group 2.
4. After the test article has been administered, food was withheld for a further 3 hours. Animals are observed individually after dosing at the 30 minutes and 4 hours, and continuous observation to day14.
5. Test item:
5.1 Record toxicity symptoms, time of their occurrence, duration, and rehabilitation details.
5.2 Mortality rate: The rate should be carefully observed and its condition should be recorded (once a day) for 14 days after the application of the test article.
5.3 Body weight: Individual weight of animals in day 1, in weekly intervals thereafter, and at the time of death or sacrifice.
5.4 Anatomical pathology and macropathology: A;; rats that survived the test should be checked for anatomical pathology and macropathology - Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- According to OECD 423 test method, the LD50 of CR SB33 was greater than 2000 mg/kg B.W.. Therefore, CR SB33 was Category 5 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab for MZ6-181200026 which is based on the SOP (SOPP-341) for the OECD 423 and OECD 423 (OECD, 2001). A total of 6 female Sprague-Dawley rats were orally dosed with CR SB33 in three animals each group, at 2000 mg/kg b.w. for both Group 1 and Group 2 in limit test. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of CR SB33 was greater than 2,000 mg/kg.
Reference
Table 1. Body weight of the rats in the study period
Group | Animal ID | Dosing Volumn (mL) | Body weight (g) Day1 Day7 Day14 |
Weight changes (g) | ||
1 | 01F | 1.9 | 182.4 | 207.0 | 217.1 | +34.7 |
1 | 02F | 2.0 | 196.3 | 233.2 | 249.6 | +53.3 |
1 | 03F | 2.1 | 207.1 | 244.1 | 268.2 | +61.1 |
2 | 04F | 2.1 | 202.2 | 239.7 | 252.7 | +50.5 |
2 | 05F | 2.0 | 192.0 | 233.9 | 233.7 | +41.7 |
2 | 06F | 1.9 | 187.4 | 219.3 | 229.4 | +42.0 |
aWeight change = body weight (day 14)-body weight (day 1).
Table 2. Clinical observation of the rats
Group | Animal ID | Clinical sign observation a | ||||||||||||||
30 mins | 4 hours | D2 b | D3 | D4 | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 | ||
1 | 01F | N c | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
1 | 02F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
1 | 03F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
2 | 04F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
2 | 05F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
2 | 06F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
aClinical sign observation including: skin, hair, eyes, activity, circulatory system, respiratory system, digestive system and urinary system.
bD X: Day X of test.
cN: Normal.
Table 3. Results of gross necropsy examination
Group | Animal ID | Dose | Gross lesion |
1 | 01F | 2,000 mg/kg BW | No significant lesion founded |
02F | No significant lesion founded | ||
03F | No significant lesion founded | ||
2 | 04F | 2,000 mg/kg BW | No significant lesion founded |
05F | No significant lesion founded | ||
06F | No significant lesion founded |
aGross lesion including: appearance, subcutis, abdomen, reproductive system, spleenm pancreas, liver, stomach, intestines, mesemteric lymph node, kidney, urinary bladder, adrenal, thorax, thymus, heart, lung, oral cavity, salivary gland, lymph nodes, muscles, esophagus, trachea and other.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Limited exposure evisaged.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Limited exposure evisaged.
Additional information
Acute toxicity: via oral route
A total of 6 female Sprague-Dawley rats were orally dosed with CR SB33 in three animals each group, at 2000 mg/kg b.w. for both Group 1 and Group 2 in limit test. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of CR SB33 was greater than 2,000 mg/kg.
Justification for classification or non-classification
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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