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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-834-9 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 13 July 2022 to 20 July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 22th July 2010
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- A dried sludge product resulting from the treatment process of domestic wastewater. The exact processes followed for the production of the dried sludge are: Preliminary & secondary treatment of the wastewater stream, thickening, dehydration and drying of the excess sludge.
- EC Number:
- 943-834-9
- Molecular formula:
- Not applicable for UVCB substances
- IUPAC Name:
- A dried sludge product resulting from the treatment process of domestic wastewater. The exact processes followed for the production of the dried sludge are: Preliminary & secondary treatment of the wastewater stream, thickening, dehydration and drying of the excess sludge.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: - Vehicle control groups: i) 4:1 Acetone-Olive Oil (AOO) ii) sesame oil iii) water
- Concentration:
- 0.2g of test material per ml of solvent at (37 ± 1) °C for (72 ± 2) h
- No. of animals per dose:
- 5
- Details on study design:
- Method
The LLNA identifies contact allergens as a function of proliferative responses induced in draining lymph nodes following topical exposure of mice to test chemicals. The mechanistic basis for selection of this endpoint is that the acquisition of skin sensitization is dependent upon, and correlates quantitatively with, T lymphocyte proliferation induced in regional lymph nodes draining the site of encounter with a contact allergen. Using the standard LLNA for the purposes of hazard identification, chemicals are classified as contact allergens if they elicit, at one or more test concentrations, a three-fold or greater increase in draining lymph node cell (LNC) proliferation compared with concurrent vehicle controls (a stimulation index [SI] of 3 or more).
Test Procedures
The experimental design of the assay is as follows:
Exaggerated extraction was performed in clean, chemically inert, closed containers with minimum dead space using 0.2g of test material per ml of solvent at (37 ± 1) °C for (72 ± 2) h; Double-distilled water was chosen as the polar solvent, whereas refined sesame oil as the non-polar solvent.
Τhe treatment groups, which consist of at least five mice, were the following:
- Vehicle control groups: i) 4:1 Acetone-Olive Oil (AOO) ii) sesame oil iii) water
- Positive control group (25% w/w α-Hexyl cinnamaldehyde in 4:1 AOO)
- Test material non-polar extract (aqueous)
- Test material polar extract (sesame oil)
A dose of 25μL/day of test material / positive control solution/ solvents was applied to the dorsal side of both ears of designated mice for three consecutive days.
Observation period: Daily (from Day 0 to Day 6)
Observations: Mortality, morbidity: at least once daily. Clinical signs, irritation: individual observation at least once daily for 6 days; body weight: on Day 1 and Day 6.
The protocol for determining the level of lymph node cell proliferation is described in ASOP and is in accordance with OECD 429 guideline.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Concurrent positive control’s SI index was 3.60. The value was in accordance with the laboratory historical data of positive control.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- Test group’s SI (non-polar extract) 0.95
Test Group’s SI (polar extract) 1.20 - Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
Any other information on results incl. tables
Appendix 1
NEGATIVE CONTROL GROUP | POSITIVE CONTROL GROUP | |||
Mouse ID # | Individual dpm | |||
| raw data | w/o blank | raw data | w/o blank |
1 | 7259.71 | 4646.415 | 15704.8 | 13091.505 |
2 | 6253.59 | 3640.295 | 16701.4 | 14088.105 |
3 | 5821.47 | 3208.175 | 13178 | 10564.705 |
4 | 7632.12 | 5018.825 | 17301.2 | 14687.905 |
5 | 4286.66 | 1673.365 |
|
|
Average dpm | ||||
3637.415 | 13108.055 | |||
Standard Deviation | ||||
1319.860055 | 1818.912418 | |||
Stimulation Index (SI) | ||||
N/A | 3.603673213 | |||
| ||||
VEHICLE CONTROL GROUP | TEST GROUP | |||
SESAME OIL | OILY EXTRACT | |||
Mouse ID # | Individual dpm | |||
| raw data | w/o blank | raw data | w/o blank |
1 | 13185.7 | 10572.405 | 10408.6 | 7795.305 |
2 | 12738.9 | 10125.605 | 10502.1 | 7888.805 |
3 | 12995.1 | 10381.805 | 15754.2 | 13140.905 |
4 | 12885.9 | 10272.605 | 12000.9 | 9387.605 |
5 | 11705.4 | 9092.105 |
|
|
Average dpm | ||||
10088.905 | 9553.155 | |||
Standard Deviation | ||||
580.5741727 | 2500.630215 | |||
Stimulation Index (SI) | ||||
N/A | 0.946897111 | |||
| ||||
The product is not considered a sensitizer. | ||||
VEHICLE CONTROL GROUP | TEST GROUP | |||
WATER | AQUEOUS EXTRACT | |||
Mouse ID # | Individual dpm | |||
| raw data | w/o blank | raw data | w/o blank |
1 | 6204.12 | 3590.825 | 4440.21 | 1826.915 |
2 | 5402.73 | 2789.435 | 5435 | 2821.705 |
3 | 5333.77 | 2720.475 | 6226.17 | 3612.875 |
4 | 3221.94 | 608.645 | 5731.25 | 3117.955 |
5 |
|
| 5869.84 | 3256.545 |
Average dpm | ||||
2427.345 | 2927.199 | |||
Standard Deviation | ||||
1275.197993 | 677.6359791 | |||
Stimulation Index (SI) | ||||
N/A | 1.205926228 | |||
| ||||
The product is not considered a sensitizer. |
Appendix 2
Weight | |||||||
Group | Mouse | Day 1 | Day 6 | ||||
1 (Negative Control) | 1 | 20.68 |
|
| 21.6 |
|
|
| 2 | 21.35 | 22.27 |
| |||
| 3 | 20.15 | AVERAGE | 20.756 | 20.86 | AVERAGE | 22.012 |
| 4 | 20.9 | SD | 0.387226 | 22.36 | SD | 0.721426 |
| 5 | 20.7 | % VARIATION | 1.87% | 22.97 | % VARIATION | 3.28% |
2 (Positive Control) | 1 | 21.94 |
|
| 22.26 |
|
|
| 2 | 20.1 | 21.22 |
| |||
| 3 | 22.41 | AVERAGE | 21.81 | 22.99 | AVERAGE | 22.236 |
| 4 | 22.05 | SD | 0.883878 | 21.72 | SD | 0.698014 |
| 5 | 22.55 | % VARIATION | 4.05% | 22.99 | % VARIATION | 3.14% |
3 (Aqueous Excipient) | 1 | 22.09 |
|
| 20.11 |
|
|
| 2 | 20.68 | 22.1 |
| |||
| 3 | 21.39 | AVERAGE | 21.338 | 22 | AVERAGE | 21.672 |
| 4 | 21.3 | SD | 0.450395 | 22.56 | SD | 0.839748 |
| 5 | 21.23 | % VARIATION | 2.11% | 21.59 | % VARIATION | 3.87% |
4 (Oily Excipient) | 1 | 20.92 |
|
| 21.34 |
|
|
| 2 | 22.18 | 20.45 |
| |||
| 3 | 23.11 | AVERAGE | 21.698 | 23.82 | AVERAGE | 21.664 |
| 4 | 21.06 | SD | 0.832692 | 21.53 | SD | 1.13836 |
| 5 | 21.22 | % VARIATION | 3.84% | 21.18 | % VARIATION | 5.25% |
5 (Aqueous Extract) | 1 | 21.73 |
|
| 21.8 |
|
|
| 2 | 23.13 | 24.67 |
| |||
| 3 | 20.84 | AVERAGE | 22.442 | 20.44 | AVERAGE | 22.658 |
| 4 | 25 | SD | 1.480451 | 24.69 | SD | 1.718713 |
| 5 | 21.51 | % VARIATION | 6.60% | 21.69 | % VARIATION | 7.59% |
6 (Oily Extract) | 1 | 23 |
|
| 23.54 |
|
|
| 2 | 22 | 22.1 |
| |||
| 3 | 23.67 | AVERAGE | 23.286 | 24.26 | AVERAGE | 23.778 |
| 4 | 23.69 | SD | 0.729509 | 23.75 | SD | 1.024 |
| 5 | 24.07 | % VARIATION | 3.13% | 25.24 | % VARIATION | 4.31% |
AVERAGE | 21.88833 | 22.33667 | |||||
SD | 1.185943 | 1.303954 | |||||
% VARIATION | 5.42% | 5.84% |
T-test analysis: Mice weights on Day 6 vs Day 1
Group | Day 6 vs Day 1 | |||
Mean of differences | 95% CI | P value | ||
All | 0.4483 | 0,1227 to 0,7740 | 0.0087 | ↑ |
1 (Negative Control) | 1.256 | 0,4722 to 2,040 | 0.0113 | ↑ |
2 (Positive Control) | 0.426 | -0,2217 to 1,074 | 0.1419 | - |
3 (Aqueous Excipient) | 0.334 | -1,363 to 2,031 | 0.6137 | - |
4 (Oily Excipient) | -0.034 | -1,258 to 1,190 | 0.9423 | - |
5 (Aqueous Extract) | 0.216 | -0,7521 to 1,184 | 0.5692 | - |
6 (Oily Extract) | 0.492 | -0,06740 to 1,051 | 0.0711 | - |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- “Dried sludge from domestic wastewater” should not be considered as a skin sensitizer according to the results of Murine Local Lymph Node Assay.
- Executive summary:
The purpose of this study was to evaluate the skin sensitization potential of the product “Dried sludge from domestic wastewater” intended to be used as fuel. For this purpose, Local Lymph Node Assay (LLNA) was performed. LLNA is a validated and accepted method used for the identification of skin sensitizing chemicals. It is the initial requirement for sensitization testing within the new REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) regulations in the European Union. Due to its high dissolubility, exaggerated extraction with a polar and and a non polar solvent was performed. Extracts were applied to the dorsum of mice ears and lymph node proliferation was assessed by measuring the level of radioactivity. Both extracts of the product exhibited Stimulation Index < 3 and the product should not be considered as a skin sensitizer according to the results of Murine Local Lymph Node Assay.
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.