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EC number: 700-957-0 | CAS number: 1141852-17-6
- 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:
- 04 - 19 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane
- EC Number:
- 700-957-0
- Cas Number:
- 1141852-17-6
- Molecular formula:
- UVCB
- IUPAC Name:
- 1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane
- Reference substance name:
- Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)
- IUPAC Name:
- Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)
- Details on test material:
- - Name of test material (as cited in study report): Y-15866
- Analytical purity: 72%
- Lot/batch No.: 3710-10
- Expiration date of the lot/batch: 2013-07-16
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., AD Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 21.2 g (animals of the range-finding test) and 21.8 g (animals of the main study)
- Housing: individually in Makrolon Type II cages with wire mesh top (EHRET GmbH, Emmendingen, Germany)
- Diet: pelleted standard diet (Harlan Laboratories B.V., AD Horst, The Netherlands), ad libitum
- Water: tap water (Gemeindewerke, Rossdorf, Germany), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25 and 50% (w/v), and 100%
- No. of animals per dose:
- Range-finding test: 1 (in test groups)
Main study: 5 (controls), 5 (in test groups) - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the compound solubility was determined according to the recommendations given in OECD guideline 429. The highest test substance concentration which can be technically used was 100% (undiluted). Further dilutions were performed in dimethylformamide (DMF).
- Irritation: to determine the highest non-irritant dose that does at the same time not induce signs of systemic toxicity, two mice were treated once daily on three consecutive days with concentrations of 50% (w/v) and 100% by topical (epidermal) application to the dorsal surface of each ear. Clinical signs were recorded within 1 h and 24 ± 4 h after each application as well as on Day 7. In addition, the initial and terminal body weights of each animal were determined. The animals did not show any signs of irritation or systemic toxicity after test substance application at concentrations of 50 and 100%. Based on these results, concentrations selected for the main study were 25, 50 and 100%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: ³H-methyl thymidine (³HTdR) incorporation determined by ß-scintillation
- Criteria used to consider a positive response: the test substance is considered a skin sensitiser in the LLNA if the following criteria were met:
(1) the exposure to at least one concentration of the test substance resulted in an incorporation of ³HTdR at least 3-fold greater than in controls (as indicated by the stimulation index) and
(2) the data were compatible with a conventional dose response, although allowance had to be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: each animal was treated by topical application of 25 µL of the different test substance concentrations and the respective vehicle (DMF as vehicle control) on the entire dorsal surface of each ear. The application was repeated on Days 2 and 3. On Day 6, each animal was treated with 250 µL of 80.9 µCi/mL ³HTdR (corresponds to 20.2 µCi ³HTdR per mouse) in phosphate buffered saline (PBS) by intravenous injection via the tail vein. After five hours, mice were euthanised by intraperitoneal injection of sodium pentobarbital and the draining auricular lymph nodes were rapidly excised. The 2 nodes of each animal were pooled and single cell suspensions (SCS) in PBS were prepared by gentle mechanical disaggregation of each pooled lymph node cells (LNCs) through a stainless steel gauze (200 µm mesh size). LNCs were pelleted by centrifugation, and washed twice with PBS. After removal of the washing solution, pellets were resuspended in 5% trichloroacetic acid and incubated at 4 °C for approximately 18 h for precipitation of macromolecules. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations of body weights and DPM values were calculated. Statistical analysis of the mean DPM values was performed between treated and control groups to assess a dose-response relationship.
Results and discussion
- Positive control results:
- A significant increase in the stimulation indices (SI = 3) was noted for the positive control substance hexyl cinnamic aldehyde in acetone:olive oil (4+1) at concentrations of 10% (SI = 3.4) and 25% (SI = 6.1), respectively.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- 59.9
- Parameter:
- SI
- Value:
- 1.71
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 2.57
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 4.75
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- Two lymph nodes of each animal were pooled and DPM values were measured from the pooled lymph node cell suspensions. The measured DPM values per animal were corrected by subtracting the background DPM values (average of two measured DPM values of 5% (w/v) trichloroacetic acid solutions). Treatment with 25, 50 and 100% test substance in DMF resulted in DPM/lymph node of 520.8, 784.6 and 1450.2, respectively.
Any other information on results incl. tables
No systems of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
Table 1. Calculation of individual DPM and SI values
Test substance concentr. |
DPM values measured |
DPM-BG per animal (2 lymph nodes)* |
SI |
||
% |
Animal No. |
Group No. |
|||
- |
- |
- |
13 (BG I) |
- |
- |
- |
- |
- |
12 (BG II) |
- |
- |
- |
1 |
1 |
530 |
518 |
- |
- |
2 |
1 |
778 |
766 |
- |
- |
3 |
1 |
511 |
499 |
- |
- |
4 |
1 |
483 |
471 |
- |
- |
5 |
1 |
813 |
801 |
- |
25 (w/v) |
6 |
2 |
811 |
799 |
1.3 |
25 (w/v) |
7 |
2 |
837 |
825 |
1.4 |
25 (w/v) |
8 |
2 |
1306 |
1294 |
2.1 |
25 (w/v) |
9 |
2 |
396 |
384 |
0.6 |
25 (w/v) |
10 |
2 |
1920 |
1908 |
3.1 |
50 (w/v) |
11 |
3 |
1288 |
1276 |
2.1 |
50 (w/v) |
12 |
3 |
2031 |
2019 |
3.3 |
50 (w/v) |
13 |
3 |
2217 |
2205 |
3.6 |
50 (w/v) |
14 |
3 |
1748 |
1736 |
2.8 |
50 (w/v) |
15 |
3 |
624 |
612 |
1 |
100 |
16 |
4 |
5466 |
5454 |
8.9 |
100 |
17 |
4 |
2288 |
2276 |
3.7 |
100 |
18 |
4 |
1565 |
1553 |
2.5 |
100 |
19 |
4 |
2982 |
2970 |
4.9 |
100 |
20 |
4 |
2263 |
2251 |
3.7 |
BG = background (1 mL 5% trichloroacetic acid)
1 = control group; 2-4: test groups
SI = stimulation index relative to the mean of the control group (group 1)
* values corrected for mean background value (BG I and BG II)
Table 2. Calculation of mean DPM and SI values
Test substance concentration |
DPM per lymph node# |
SI |
Vehicle |
305.3 |
1.00 |
25% |
520.8 |
1.71 |
50% |
784.6 |
2.57 |
100% |
1450.2* |
4.75 |
# DPM/node was determined by dividing the sum of the measured values from all lymph nodes within a group by the number of lymph nodes taken from that group.
*Statistically significant compared to control (p = 0.005)
Table 3. Calculation of the EC3 value
Test group |
Test substance concentration |
SI |
3 |
50% (a) |
2.57 (b) |
4 |
100% (c) |
4.75 (d) |
EC3 = (a-c) [(3-d)/(b-d)] + c = 59.9 % |
EC3 = estimated concentration for a SI of 3
a, b, c, d = co-ordinates for the 2 pairs of data lying immediately above and below the SI value of 3 on the LLNA dose response plot
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of an LLNA, performed according to OECD/EC guidelines, Y-15866 is concluded to be a skin sensitiser. As the LLNA is not considered a suitable test for silicone materials, the result is disregarded and further testing to address this endpoint has been initiated.
- Executive summary:
The skin sensitising potential of Y-15866 was investigated in a Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429 and in compliance with GLP. Based on a preliminary test in two female CBA/CaOlaHsd mice, the undiluted test substance (100%) and dilutions of 25 and 50% (w/v) of the test substance in dimethylformamide (DMF) were selected as treatment concentrations for the main study. In this experiment, 5 female CBA/CaOlaHsd mice per test group were treated with the undiluted or diluted test substance or vehicle alone, respectively. The test substance formulations or the vehicle were applied on the external surface of each ear (25 µL/ear) for three consecutive days. Five days after the first topical application, the cell proliferation of pooled lymph nodes from individual animals was measured by incorporation of ³H-methyl thymidine and expressed as the amount of radioactive disintegration per minute (DPM). The mean DPM/lymph node for each test group was 520.8, 784.6 and 1450.2 at concentrations of 25, 50 and 100% of the test substance, respectively. Treatment with the undiluted test substance (100% concentration) resulted in a statistically significant increase in DPM/lymph node (1450.2) compared to control values (DPM/node = 305.3) and showed a clear dose-response relationship. Based on these results, stimulation indices of 4.75, 2.57 and 1.71 were calculated for the treatment concentrations of 100%, 50% and 25%, respectively. The estimated concentration for a stimulation index of 3 (EC3) was 59.9%. No local or systemic toxicity and no effects on body weights were observed. The historical positive control hexyl cinnamic aldehyde confirmed the sensitivity and reliability of the experimental technique (SI = 3). Under the above mentioned conditions, the test substance was found to be a sensitiser in the LLNA.
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