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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
Skin irritation
The Primary Irritation Index (PII) of CR SB33 was 0 and CR SB33 was categorized as non-irritant (OECD TG404).
Eye irritation
CR SB33 was not any irritant to the eye (OECD TG405).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 4, 2019 to March 14, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 2.09 to 2.42 kg
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12hrs dark / 12hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL normal saline
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24 ± 1, 48 ± 1, 72 ± 1 hrs
- Number of animals:
- 3
- Details on study design:
- - Area of exposure: upper left and lower right dorsal Area
- Washing (if done): with distilled Water
After evaluating, test article had not been judged to be corrosive, so test article did not perform preliminary test and directly applied on main test.
Main study:
Before the test, 15 cm x 10 cm area over the dorsal region o f each test animal was shaved. The shoulder skin examination did not have any injury and marked the positions of the test and control area.
Gauze about 2.5cm x 2.5cm was evenly loaded with 0.5g test article and wetted by physiological saline. The gauzes were applied on the upper left and lower right dorsal skin of test animals.
Gauze patch about 2.5cm x 2.5cm was fully loaded with 0.5mL control article. The gauzes were applied on the upper right and lower left dorsal skin of test animals.
The gauzes loaded test article or control article were closely contact with dorsal skin of test animal through tightened bandage. After 4 hours working, the gauzes were taken off. The test area and control area were cleaned with water.
After gauzes taken off, the irritation response of rabbit skin was evaluated at 1, 24, 48, and 72 hours. Any skin irritation response, including erythema and edema was graded and recorded according to the ‘Grading system for skin reaction”. - Irritation parameter:
- erythema score
- Basis:
- animal: 153, 154, 155
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 153, 154, 155
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 404 test method and Evaluation table for single dermal irritation, the PII for CR SB33 was 0 and CR SB33 was categorized as non-irritant. Therefore, CR SB33 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for MZ6 -181200022 which is based on the SOP for the OECD 404 (SOPP-305) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB33 was calculated to be 0. On the basis of the test results given above and according to Evaluation table for single dermal irritation, the response of CR SB33 was categorized as non-irritant.
Reference
Table 1. Body weight of the rabbits
Animal ID | Sex | Day 1 | Day 4 |
153 | male | 2.37 | 2.42 |
154 | male | 2.29 | 2.30 |
155 | male | 2.09 | 2.19 |
Table 2. Individual skin reactions
Animal ID | Observation time(hours) |
Skin grading (erythema/edema) Test area Control area Upper left Lower right Lower left Upper right |
||||
153 | 1 | 0/0 | 0/0 | 0/0 | 0/0 | |
153 | 24 | 0/0 | 0/0 | 0/0 | 0/0 | |
153 | 48 | 0/0 | 0/0 | 0/0 | 0/0 | |
153 | 72 | 0/0 | 0/0 | 0/0 | 0/0 | |
154 | 1 | 0/0 | 0/0 | 0/0 | 0/0 | |
154 | 24 | 0/0 | 0/0 | 0/0 | 0/0 | |
154 | 48 | 0/0 | 0/0 | 0/0 | 0/0 | |
154 | 72 | 0/0 | 0/0 | 0/0 | 0/0 | |
155 | 1 | 0/0 | 0/0 | 0/0 | 0/0 | |
155 | 24 | 0/0 | 0/0 | 0/0 | 0/0 | |
155 | 48 | 0/0 | 0/0 | 0/0 | 0/0 | |
155 | 72 | 0/0 | 0/0 | 0/0 | 0/0 |
Table 3. Primary irritation scores of rabbit skin irritation test
Animal ID | Irritation scoresa Test area Control area |
Primary Iriitation Scores (PIS)b | |
153 | 0 | 0 | 0 |
154 | 0 | 0 | 0 |
155 | 0 | 0 | 0 |
Primary irritatioin index (PII)c = 0 |
a Irritation cores were the sum of each rabbit irritation values at three time points and then divided by the total number of observation.
b PIS = (scores of test area) – (scores of control area).
c PII = Sum of PIS ÷ number of animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals were no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB33 was calculated to be 0. On the basis of the test results given above and according to the Evaluation table for single dermal irritation, the response of CR SB33 was categorized as non-irritant.
Eye irritation
The body weight of rabbits was increased normally. It indicates that the test article did not affect the body weight of the testing rabbits. Both eyes of the test animals were examined at 1, 25, 49, and 73 hours after the test article application.
Both eyes of testing rabbits showed normal ocular morphology, including cornea transparent and no ulceration, normal iris morphology without congestion and swelling and normally respond to light, and distribution of normal conjunctivae vessels without swelling or discharge. Grades of the irritation reaction were 0. Therefore, the test article CR SB33 did not cause any irritation response on the eye of rabbits under the conditions designed for this study and did not classify as eye irritants.
Justification for classification or non-classification
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