Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 sensitization
The stimulation index of the low dose, medium dose, and high dose group were 1.03, 0.96 and 0.58, respectively, and all < 1.6. Therefore, CR SB33 did not cause skin sensitization effect on CBA/CaJNarl mice.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 5, 2019 to September 16, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- other: CBA/CaJNarl
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: National Laboratory Animal Center
- Weight at study initiation: 18.6-23.1g
- Animal feeding situation: 1 mouse per cage (for preliminary test), 4 mice per cage (for definitive test).
- Acclimation period: 7 days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Frequemcy of ventilation: 10~15 times/hour.
- Photoperiod: 12-hrs dark / 12-hrs light - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 100, 200 mg/mL
- No. of animals per dose:
- For Control group: four
For Test group: sixteen - Details on study design:
- Preliminary test: This study was comprised of four groups, a vehicle control (acetone : olive oil = 4 : 1, v/v) and three doe groups. Each group had one mouse. At the beginning of the study, the body weight of each mouse was measured and recorded. The control and test article were applied to the dorsum of two ears in each mouse with 25 µL. The clinical observation of the mice was conducted each day for 6 days, and the erythema and thickness for each mouse ears were recorded at day 1, day 3 and day 6.
Definitive test: This study was comprised of 5 groups, a vehicle control (acetone : olive oil = 4 : 1, v/v), a positive control (25% hexyl cinnamic aldehyde and 25% eugenol in acetone : olive oil = 4 : 1, v/v), a low dose group ( 50 mg/mL), a medium dose group (100 mg/mL) and a high dose group (200mg//mL). There were four mice in each group. The controls and test articles were applied to the dorsum of two ears in each mouse at day 1, day 2 and day 3 with 25 µL. The 25 mg/mL BrdU solution was administrated 0.2 mL through intraperitoneal injection at day 5. 24 hours after BrdU injection, sacrificed the mice by CO2.Excised the auricular lymph nodes from each mouse ear and process separately in PBS. The erythema and thickness were recorded before sacrificed. Preparation of cell suspensions: The lymph node from each mouse were excised by mechanical disaggregation through 200 micron-mesh sterile stainless steel gauze. The target volume was adjusted to 15 mL. The BrdU in proliferative cells was determined by the BrdU ELISA kit. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- eugenol (CAS No 97-53-0)
- Statistics:
- 1. Clinical observations were conducted during the study period and animal deaths should be documented.
2. Calculation of BrdU labeling index = (Absorbance of emission wave length OD 370 nm - Average of balnk absorbance of emission wavelength) - (Absorbance of reference wavelength OD 492 nm – Average of blank absorbance of reference wavelength).
3. Calculation of stimulation index (SI) = BrdU labeling index within vehicle control.
4. The result as positive when SI>=1.6. However, the dose-response relationship and statistical analysis including Duncan’s multiple range test of one-way ANNIVA and Dunnett’s test were used when SI between 1.6 and 1.9. A significant difference was defined as p<0.05. - Positive control results:
- The stimulation index of the positive control group was 7.22. The stimulation index of the low dose, medium dose, and high dose groups were 1.03, 0.96 and 0.58, respectively.
- Parameter:
- SI
- Remarks:
- stimulation index
- Value:
- 1
- Test group / Remarks:
- Vehicle control
- Parameter:
- SI
- Remarks:
- stimulation index
- Value:
- 7.22
- Test group / Remarks:
- Positive control
- Parameter:
- SI
- Remarks:
- stimulation index
- Value:
- 1.03
- Test group / Remarks:
- low dose
- Parameter:
- SI
- Remarks:
- stimulation index
- Value:
- 0.96
- Test group / Remarks:
- medium dose
- Parameter:
- SI
- Remarks:
- stimulation index
- Value:
- 0.58
- Test group / Remarks:
- high dose
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted according to OECD 442B: 2018. The results indicated that there was no skin erythema of the mice ears in all groups. The ear thickness of test groups were significant increased compared to vehicle control group. BrdU labeling index of low, medium and high dose group were no significantly different with vehicle control group and showed 1.03, 096 and 0.58 in stimulation index, respectively. Therefore, the test article " CR SB33" under the conditions designed for this study, did not cause skin sensitization effect on CBA/CaJNarl mice.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for MZ6-181200024 which is based on the SOP for the OECD 442B: 2018 and SuperLab standard operating procedure SOPP-347. CBA/CaJNarl female mice were used in this study. The study included vehicle control group, positive control group, low dose group (50mg/mL), divided into 5 groups randomly. There were 4 mice in each group. Control article or test article were applied on the dorsum of two ears in each mouse of each group on Day 1~3. BrdU solution was administered by intraperitoneal injection on Day 5. Ear thickness and erythema were recorded on Day 6, and the posterior ear lymph nodes were collected and prepared in phosphate buffer solution to cellular suspension. The BrdU content of each group was detected by ELISA kit and calculated the stimulation index (SI) of each group. The results showed that the mice in each group had no erythema on the ear skin on Day 6. The thickness of the ear in test groups were all significant increased compared with the vehicle control group. The stimulation index calculated showed that low, medium and high dose groups were 1.03, 0.96 and 0.58. The result was negative. Therefore, CR SB33 under the conditions designed for this study, did not cause skin sensitization effect on mice.
Reference
Table 1. The body weight changes of the mice during study
Group | Animal ID | Body weight (g) | Weight changesa (g) | |
Day 1 | Day 6 | |||
Vehicle control |
01F |
19.9 |
20.0 |
+0.1 |
02F |
21.5 |
21.5 |
+0.0 |
|
03F |
21.2 |
21.3 |
+0.1 |
|
04F |
21.2 |
21.2 |
+0.0 |
|
Mean ± SD |
21.98± 0.70 |
22.20± 0.71 |
||
Positive control | 05F | 22.7 | 22.8 | +0.1 |
06F | 22.8 | 22.8 | +0.0 | |
07F | 19.7 | 19.8 | +0.1 | |
08F | 20.7 | 20.8 | +0.1 | |
Mean ± SD | 22.38± 0.59 | 22.53± 0.62 | ||
Low dose | 09F | 21.1 | 21.2 | +0.1 |
10F | 22.5 | 22.5 | +0.0 | |
11F | 23.1 | 23.2 | +0.1 | |
12F | 21.6 | 21.7 | +0.1 | |
Mean ± SD | 22.38 ± 0.69 | 22.55± 0.68 | ||
Medium dose |
13F |
21.0 |
21.0 |
+0.0 |
14F |
18.6 |
18.7 |
+0.1 |
|
15F |
21.5 |
21.5 |
+0.0 |
|
16F |
21.3 |
21.4 |
+0.1 |
|
Mean ± SD |
22.40 ± 0.32 |
22.65 ± 0.24 |
|
|
High dose
|
17F |
22.0 |
22.0 |
+0.0 |
18F |
20.5 |
20.6 |
+0.1 |
|
19F |
18.8 |
18.9 |
+0.1 |
|
20F |
19.4 |
19.5 |
+0.1 |
|
Mean ± SD |
21.8 ± 0.61 |
22.03 ± 0.62 |
|
aWeight changes = body weight (day 6) - body weight (day 1).
Table 2. Results of mice clinical observations
Group | Animal ID | Clinical observation | |||||
Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | ||
Vehicle control | 01F |
Na | N | N | N | N | N |
02F | N | N | N | N | N | N | |
03F | N | N | N | N | N | N | |
04F | N | N | N | N | N | N | |
Positive control | 05F | N | N | N | N | N | N |
06F | N | N | N | N | N | N | |
07F | N | N | N | N | N | N | |
08F | N | N | N | N | N | N | |
Low dose | 09F | N | N | N | N | N | N |
10F | N | N | N | N | N | N | |
11F | N | N | N | N | N | N | |
12F | N | N | N | N | N | N | |
Medium dose | 13F | N | N | N | N | N | N |
14F | N | N | N | N | N | N | |
15F | N | N | N | N | N | N | |
16F | N | N | N | N | N | N | |
High dose | 17F | N | N | N | N | N | N |
18F | N | N | N | N | N | N | |
19F | N | N | N | N | N | N | |
20F | N | N | N | N | N | N |
aN: normal
Table 3. Thickness and erythema of mice
Group | Animal ID | Thickness (mm) | Erythema scorea | ||
Left ear | Right ear | Left ear | Right ear | ||
Vehicle Control | 01F | 0.16 | 0.17 | 0 | 0 |
02F | 0.18 | 0.19 | 0 | 0 | |
03F | 0.17 | 0.19 | 0 | 0 | |
04F | 0.16 | 0.16 | 0 | 0 | |
Mean ± SD |
0.17 ± 0.01 |
0.00 ± 0.0 |
|||
Positive control |
05F |
0.38 |
0.45 |
3 |
4 |
06F |
0.37 |
0.47 |
3 |
4 |
|
07F |
0.40 |
0.37 |
4 |
4 |
|
08F |
0.37 |
0.45 |
3 |
4 |
|
Mean ± SD |
0.41 ± 0.04* |
3.63 ± 0.5 |
|||
Low dose |
09F |
0.26 |
0.21 |
0 |
0 |
10F |
0.20 |
0.21 |
0 |
0 |
|
11F |
0.21 |
0.22 |
0 |
0 |
|
12F |
0.20 |
0.20 |
0 |
0 |
|
Mean ± SD |
0.21 ± 0.02* |
0.00 ± 0.0 |
|||
Medium dose |
13F |
0.19 |
0.20 |
0 |
0 |
14F |
0.20 |
0.20 |
0 |
0 |
|
15F |
0.19 |
0.22 |
0 |
0 |
|
16F |
0.21 |
0.22 |
0 |
0 |
|
Mean ± SD |
0.20 ± 0.01* |
0.00 ± 0.0 |
|||
High dose |
17F |
0.23 |
0.21 |
0 |
0 |
18F |
0.22 |
0.22 |
0 |
0 |
|
19F |
0.21 |
0.22 |
0 |
0 |
|
20F |
0.23 |
0.22 |
0 |
0 |
|
Mean ± SD |
0.22 ± 0.01* |
0.00 ± 0.0 |
adepended on Erythema Scores to evaluate skin erythema.
* Thickness of ear significant difference with Vehicle control (p<0.05). Analyzed by Dunnett's test of one-way ANOVA.
Table 4. The level of BrdU
Group | BrdU labeling index a | stimulation index b |
Vehicle control | 0.129 ± 0.077 |
1.00 |
Positive control |
0.931 ± 0.349* |
7.22 |
Low dose |
0.133 ± 0.062 |
1.03 |
Medium dose |
0.123 ± 0.010 |
0.96 |
High dose |
0.075 ± 0.020 |
0.58 |
a BrdL labeling index = (Absorbance of emission wave length OD 370 nm - Average of balnk absorbance of emission wavelength) - (Absorbance of reference wavelength OD 492 nm – Average of blank absorbance of reference wavelength).
b stimulation index (SI) = BrdU labeling index within vehicle control, each test article group and positive control / the mean BrdU labeling index within vehicle control.
*BrdU significant difference with vehicle control (p<0.05). Analyzed by Dunnett's test of one-way ANOVA.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Skin sensitization
CBA/CaJNarl female mice were used in this study. The study included vehicle control group, positive control group, low dose group (50mg/mL), divided into 5 groups randomly. There were 4 mice in each group. Control article or test article were applied on the dorsum of two ears in each mouse of each group on Day 1~3. BrdU solution was administered by intraperitoneal injection on Day 5. Ear thickness and erythema were recorded on Day 6, and the posterior ear lymph nodes were collected and prepared in phosphate buffer solution to cellular suspension. The BrdU content of each group was detected by ELISA kit and calculated the stimulation index (SI) of each group. The results showed that the mice in each group had no erythema on the ear skin on Day 6. The thickness of the ear in test groups were all significant increased compared with the vehicle control group. The stimulation index calculated showed that low, medium and high dose groups were 1.03, 0.96 and 0.58. The result was negative. Therefore, CR SB33 under the conditions designed for this study, did not cause skin sensitization effect on mice.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.