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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 612-028-6 | CAS number: 607724-47-0
- 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
The sensitization potential of Blendazol Red Blendwellwas evaluated using the Local Lymph Node Assay (LLNA). The LLNA has been developed to determine the allergic contact sensitization potential of chemicals.
Based on the recommendations of the OECD Guideline 429, the test item was dissolved in DMSO. The positive control (a-Hexylcinnamic aldehyde) (25%) was dissolved in same vehicle.
ThePre-screen testwas performed using a dose of 100 %. Based on the observations recorded in the Pre-screen tests, the concentration of 100 % was selected as top dose for the main test.
Five female mice (CBA/Ca) per group were topically exposed (dorsum of both ears) to the test item at concentrations of 25%, 50% and 100%, to the positive control and to the vehicle alone. Lymphocyte proliferation was measured using incorporation of radioactive125I-iododeoxyuridine and 10-5M fluorodeoxyuridinein the draining lymph nodes. The radioactive incorporation was expressed as disintegrations per minute (DPM)/pooled treatment group and compared with DPM value from the vehicle control group and expressed as the Stimulation Index (SI).
After application of the test itemat three concentrations (25%, 50% and 100% w/v) the animals did not show visible clinical symptomsof either local irritation or systemic toxicity.
In this study the mean Stimulation Indices (SI) of2.08, 3.43 and 5.09 were determined with the test item at concentrations of 25%, 50%, and 100% in DMSO, respectively. The calculated concentration eliciting SI of 3 (EC3) was 42.0%.
The test item Blendazol Red Blendwell is considered a skin sensitizer under the test conditions of this study.
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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:AnLab Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: free
- Age at study initiation: 8-10 weeks
- Weight at study initiation:
- Housing:
The animals were housed in polypropylene cages (5 animals per cage) suspended on stainless steel racks, in a room equipped with central air-conditioning. The room temperature was within the range of 22 ± 3°C, relative humidity was within the range of 50 - 60 %. The light regimen was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to standard operation procedures
- Diet (e.g. ad libitum):
A laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was served ad libitum, each day approximately at the same time.
- Water (e.g. ad libitum): tap water for human consumption
- Acclimation period: 6 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°
- Humidity (%): within the range of 50 - 60 %.
- Air changes (per hr): +/-3°C
- Photoperiod (hrs dark / hrs light): 12-hour light / 12-hour dark cycle
- IN-LIFE DATES: From: To: 24/05/2017 TO 20/06/2017 - Vehicle:
- dimethyl sulphoxide
- Remarks:
- Lot number : SZBG 1310V from Honeywell, Germany
- Concentration:
- 25%; 50% and 100%,
- No. of animals per dose:
- 2 mice/group per dose
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test item was insoluble in the vehicle; therefore, a homogeneous suspension was obtained.
- Irritation: no
- Systemic toxicity: no
The test item was administered in two mice at concentration of 100%. After the test item application, no signs of local irritation at the application site or systemic toxicity were observed
On day 1 (pre dose), day 3 and day 6 the ear thickness was measured
- Ear thickness measurements: the increase in ear thickness did not meet the criteria
- Erythema scores: 0
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet
redness) to eschar formation preventing grading of erythema 4
TREATMENT PREPARATION AND ADMINISTRATION:
Day 1:
Each animal was identified and the body weight was recorded. To the dorsum of each ear 25µL of the appropriate dilution of the test item, or the vehicle alone was applied.
Days 2 and 3:
The application procedure carried out on day 1 was repeated.
Days 4 and 5: No treatment.
Day 6:
The body weight of each animal was recorded. 250µL of phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Number of animals:
5 females – control (vehicle)
5 females – positive control
15 females – test item
4 females - pre-screen test plus spare animals - Positive control results:
- Lymph node weight (g) Number of lymph nodes DPM SI
Positive Control 0.0699 10 12996 8.25 - Key result
- Parameter:
- EC3
- Value:
- ca. 42
- Test group / Remarks:
- 25% 50% & 100%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.08
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 3.43
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 5.09
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
:
In comparison with the control group, an increase of the pooled lymph node weights was recorded at all used concentrations. The pooled lymph node weights of treated groups were 0.0476g for 25% concentration, 0.0516g for 50% concentration and 0.0606g for 100% concentration of tested item. The lymph node weight of control group and positive control group were 0.0311g and 0.0699g, respectively. The DPM values for the three treated groups were 3269 (25%), 5406 (50%) and 8021 (100%), respectively. The SI values for the three treated groups were 2.08 (25%), 3.43 (50%) and 5.09 (100%), respectively. The EC3 value is calculated to be 42.0%.
DETAILS ON STIMULATION INDEX CALCULATION :
The SI was obtained by dividing the pooled DPM for each treatment group by the incorporation of the pooled DPM vehicle control group; this yields a mean SI.
EC3 CALCULATION
EC3 value, which induce stimulation indices, is determined by linear interpolation of points on dose-response curve, immediately above and below of SI value, according to the equation:
EC3=c+[(3-d)/(b-d)]x(a-c)
a – higher concentration, b – SI of higher concentration, c – lower concentration
d – SI of lower concentration
If all points are below the stimulation index of three, no EC3 value can be stated.
CLINICAL OBSERVATIONS:
Animals were carefully observed for any clinical symptoms, either of local irritation at the application site or systemic toxicity. The daily clinical observation of the animals did not show visible clinical signs.
BODY WEIGHTS
The animal body weights were measured prior to the first treatment and at the scheduled sacrifice. A minor increase of body weight was observed in all treated groups. The increase was not statistically significant. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- These results demonstrate that Blendazol Red Blendwell is a potential skin sensitizer under the test conditions of this study.
- Executive summary:
The skin sensitization potential of Blendazol Red Blendwell was evaluated by LLNA method, which was developed based on scientific understanding of the immunological mechanism of skin sensitization.
In our experiments, the test item was applied over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs.In comparison with the control group, the increase in lymph node weight was observed in all treated groups. The increase of lymph node weight was dose dependent. A similar trend was registered in the evaluation of DPM of the lymph nodes.The EC3 value is calculated to be 42.0%. As the SI for some treatment dose group is ≥3 and a clear dose response is observed, the test item is regarded as a potential skin sensitizer (2, 11).
These results demonstrate that Blendazol Red Blendwell is a potential skin sensitizer under the test conditions of this study.
Reference
1.1.1 Lymph Node Proliferation
In comparison with the control group, an increase of the pooled lymph node weights was recorded at all used concentrations. The pooled lymph node weights of treated groups were 0.0476g for 25% concentration, 0.0516g for 50% concentration and 0.0606g for 100% concentration of tested item. The lymph node weight of control group and positive control group were 0.0311g and 0.0699g, respectively. The DPM values for the three treated groups were 3269 (25%), 5406 (50%) and 8021 (100%), respectively. The SI values for the three treated groups were 2.08 (25%), 3.43 (50%) and 5.09 (100%), respectively. The EC3 value is calculated to be 42.0%.
The mean Lymph node weight, DPM, SI, EC3 values.
|
Lymph node |
Number of |
|
|
|
|
weight (g) |
lymph nodes |
DPM |
SI |
EC3 (%) |
Control |
0.0311 |
10 |
1575 |
- |
42.0
|
Positive Control |
0.0699 |
10 |
12996 |
8.25 |
|
Blendazol Red Blendwell 25% |
0.0476 |
10 |
3269 |
2.08 |
|
Blendazol Red Blendwell50% |
0.0516 |
10 |
5406 |
3.43 |
|
Blendazol Red Blendwell 100% |
0.0606 |
10 |
8021 |
5.09 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of Blendazol Red Blendwellwas evaluated by LLNA method, which was developed based on scientific understanding of the immunological mechanism of skin sensitization.
In our experiments, the test item was applied over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs.In comparison with the control group, the increase inlymph node weightwas observedin all treated groups. The increase of lymph node weight was dose dependent.A similar trend was registered in the evaluation of DPM of the lymph nodes.The EC3 value is calculated to be 42.0%. As the SI for some treatment dose group is ≥3 and a clear dose response is observed, the test item is regarded as a potential skin sensitizer (2, 11).
These results demonstrate that Blendazol Red Blendwell is a potential skin sensitizer under the test conditions of this study.
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.