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EC number: 500-425-6 | CAS number: 159034-91-0 1 - 6.5 moles ethoxylated
- 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:
- 19 June 2012 - 20 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine
- EC Number:
- 500-425-6
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine
- Cas Number:
- 159034-91-0
- Molecular formula:
- Not available for this UVCB
- IUPAC Name:
- Reaction product of poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[(1-oxo-2-propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) and N-ethylethanamine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: on the beginning of the treatment period, the animals of the preliminary test were approximately 8 (first assay) or 9 (complementary assay) weeks old and the animals of the main test were approximately 9 weeks old
- Mean body weight at study initiation: the animals of the preliminary test had a mean body weight of 19.8 g (range: 19.0 g to 21.1 g) and the animals of the main test had a mean body weight of 20.7 g (range: 18.6 g to 22.4 g)
- Fasting period before study: no
- Housing: the animals were housed by group of two (preliminary test) or four (main test) in polycarbonate cages
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: the animals were acclimated to the study conditions for a period of 6 (first preliminary assay) or 13 (main test) days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 27 June 2012 to 16 July 2012.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.25, 0.5, 1, 2.5 and 5%.
- No. of animals per dose:
- 4 per dose.
- Details on study design:
- RANGE FINDING TESTS:
The maximum concentration tested in the main test was selected according to the criteria specified in the OECD Guidelines and on the basis of the data that was obtained in the preliminary test:
- the vehicle should be selected on the basis of producing a homogeneous preparation suitable for application of the test item,
- the concentrations were selected from the concentration series 100% (when test item can be sampled by a pipette), 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%, etc.,
- the maximum concentration of the test item was selected to avoid overt systemic toxicity and excessive local skin irritation the latter being defined by an > 25% increase of the ear thickness.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay
- Criteria used to consider a positive response: stimulation Index SI >= 3 and dose-relationship; additional consideration of ear thickness
TREATMENT PREPARATION AND ADMINISTRATION:
- Treatment preparation: The test item was prepared at the chosen concentrations in the vehicle.
The positive control was dissolved in AOO at the concentration of 25% (v/v).
- Administration:
On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no
Results and discussion
- Positive control results:
- The threshold positive value of 3 for the SI was reached in the positive control group (SI = 20.99). The experiment was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 6.15
- Test group / Remarks:
- Dose 0.25%
- Parameter:
- SI
- Value:
- 3.23
- Test group / Remarks:
- Dose 0.5%
- Parameter:
- SI
- Value:
- 6.73
- Test group / Remarks:
- Dose 1%
- Parameter:
- SI
- Value:
- 72.65
- Test group / Remarks:
- Dose 2.5%
- Parameter:
- SI
- Value:
- 128.99
- Test group / Remarks:
- Dose 5%
- Key result
- Parameter:
- EC3
- Value:
- < 0.25
- Test group / Remarks:
- treated group
- Cellular proliferation data / Observations:
- Dose of 0.25%: SI = 6.15 Dose of 0.5%: SI= 3.23 Dose of 1%: SI = 6.73 Dose of 2.5%: SI=72.65 Dose of 5%: SI = 128.99
DPM per group: Group 5: Vehicle: 47 Group 6: 0.25%: 289.13 Group 7: 0.5%: 152 Group 8: 1%: 316.13 Group 9: 2.5%: 3414.50 Group 10: 5%: 6062.75
Any other information on results incl. tables
Table of results :
Treatment |
Concentration |
Irritation level |
Stimulation Index |
Test item |
0.25 |
I |
6.15 |
Test item |
0.5 |
I |
3.23 |
Test item |
1 |
I |
6.73 |
Test item |
2.5 |
I |
72.65 |
Test item |
5 |
I |
128.99 |
HCA |
25 |
- |
20.99 |
-: not recorded.
I: non-irritant (increase in ear thickness < 10%).
Mortality and clinical signs
No unscheduled deaths and no clinical signs were observed during the observation period.
Local irritation (main test)
No local reactions were observed in any animals.
No notable increase in ear thickness was observed at any tested concentrations.
Proliferation assay
The SI of the positive control was > 3; this experiment was therefore considered valid.
A dose-related increase in the SI was recorded at concentrations = 0.5%, and the threshold positive value of 3 was exceeded at the concentration of 0.25%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity.
The EC3 value is considered to be < 0.25%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item gave a positive result in the murine Local Lymph Node Assay, indicative of skin sensitization properties.
According to the EC3 value obtained, the test item should be considered as a strong or extreme sensitizer. - Executive summary:
The objective of this study was to evaluate the potential of the test item to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA).
This study was performed according to the international guidelines (OECD No. 429 and Council Regulation No. 440/2008 of 30 May 2008, Part B.42) andin compliance with the principles of Good Laboratory Practice.
Methods
To assess the irritant potential of the test item (through ear thickness measurement), a preliminary test was first performed in order to define the test item concentrations to be used in the main test. Four groups of two male mice received the test item by topical route to the dorsal surface of both ears (one concentration per ear) on days 1, 2 and 3 at concentrations of 0.5, 1, 2.5, 5, 10, 25, 50 or 100% under a dose-volume of 25 µL. From day 1 to day 3 then on day 6, the thickness of both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recordedonce during the acclimation period, and thenon days 1 and 6.On completion of the observation period, the animals were sacrificedthen discarded without macroscopic post-mortem examination.
In the main test, five groups of four female mice received the test item by topical route to the dorsal surface of both ears on days 1, 2 and 3 at concentrations of 0.25, 0.5, 1, 2.5 or 5% under a dose-volume of 25 µL. One negative control group of four females received the vehicle (acetone/olive oil (4/1; v/v)) under the same experimental conditions. One positive control group of four females received the positive control, a-hexylcinnamaldehyde (HCA), at 25% in a mixture acetone/olive oil (4/1; v/v) under the same experimental conditions.
From day 1 to day 3 then on day 6, the thicknessof the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6.
After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-TdR.
The results were expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI).
Results
No unscheduled deaths and no clinical signs were observed during the observation period.
No local reactions were observed in any animals. No notable increase in ear thickness was observed at any tested concentrations.
The SI of the positive control was > 3; this experiment was therefore considered valid. A dose-related increase in the SI was recorded at concentrations = 0.5%, and the threshold positive value of 3 was exceeded at the concentration of 0.25%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity. The EC3 value is considered to be < 0.25%.Conclusion
The test item gave a positive result in the murine Local Lymph Node Assay, indicative of skin sensitization properties.
According to the EC3 value obtained, the test item should be considered as a strong or extreme sensitizer.
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