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EC number: 292-124-9 | CAS number: 90552-04-8
- 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:
- weight of evidence
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- reduced LLNA
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- EC Number:
- 292-124-9
- EC Name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- Cas Number:
- 90552-04-8
- Molecular formula:
- C(17-19)H(32-36)O2
- IUPAC Name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 0023067499
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., NL-5961 NM Horst
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.4 - 22.6 g (main test); 16.9 - 22.2 g (pretest)
- Housing: single housing (Polycarbonate cages type MIi with mesh wire tops)
- Diet (e.g. ad libitum): ad libitum (Mouse and rat maintenance diet "GLP", Granovit AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least 5 days before the first application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 25% (Challenge Treatment: 2.5; 5; 10 and 25% in MEK)
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
Randomization: Prior to first application, the animals will be distributed to the individual groups, will receive their animal numbers and will be allocated to the respective cages according to the randomization instructions of WinRando Version 3.2.
Form of application: Epicutaneous application is simulating dermal contact with the compound, which can occur under practical use conditions.
Application volume: 25 μL per ear
Site of application: Dorsal surface of both ears
Frequency of application: 3 consecutive applications (study day 1 - study day 3) to the same application site. Single challenge treatment on study day 21.
3H-thymidine injection: On study day 23 the mice will be injected intravenously (i.v.) with 20 μCi of 3H-thymidine1 in 250 μL of sterile saline into a tail vein of the mice.
Determination of ear weight: lmmediately after sacrifice, a circular piece of tissue (diameter 0.8 cm) will be punched out of the apical part of each ear of all animals. The weight of the pooled punches will be determined
for each animal using an analytical balance. These measurements serve for detecting a potential inflammatory ear swelling.
Removal and weight determination of the lymph nodes: Subsequently, the auricular lymph nodes (right and left) will be dissected. lmmediately after the removal, the total weight of both lymph nodes of each animal will be determined using an analytical balance.
Preparation of cell suspension and determination of cell counts: Both lymph nodes (per animal) will be passed carefully through an iron mesh (mesh size 200 μm) into phosphate-buffered physiological saline. lmmediately afterwards, the cell suspension will be further diluted with isotone and measured by a cell counter straight away.
Measurement of 3H-thymidine incorporation into lymph node cells: The cell suspensions will be washed twice with phosphatebuffered saline (PBS) and precipitated with 5% trichloro-acetic acid (TCA). Each precipitate will be transferred to scintillation fluid and incorporation of 3H-thymidine will be measured by a ß-scintillation counter.
Body weight determination: Individual body weights on study day 1 prior to the first application and prior to sacrifice of the animals on study day 23.
Signs and symptoms: Obvious signs of systemic toxicity will be checked individually during application (study days 1, 2, 3 and 21) and on study day 23, respectively. Local inflammation at the application sites will be checked individually during application (study days 2, 3 and 21) and on study day 23, respectively.
Mortality: A check for moribund and dead animals will be made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays. - Statistics:
- Wilcoxon-Test
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- vehicle MEK / challenge 25% in MEK
- Parameter:
- SI
- Value:
- 2.06
- Test group / Remarks:
- 25% in MEK / challenge 25% in MEK
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 25% in MEK / challenge 10% in MEK
- Parameter:
- SI
- Value:
- 1.45
- Test group / Remarks:
- 25% in MEK / challenge 5% in MEK
- Parameter:
- SI
- Value:
- 1.57
- Test group / Remarks:
- 25% in MEK / challenge 2.5% in MEK
- Cellular proliferation data / Observations:
- The single application of the 25% test-substance concentration at d21 to the challenge control animals (test group 1) induced statistically significant increases of 3H-thymidine incorporation into the cells and in the auricular lymph node cell counts, which both failed to reach the cut-off (SI 3 for 3H-thymidine incorporation and SI 1.5 for the auricular lymph node cell counts). Additionally, statistically significant increase in lymph node weight was observed in the challenge control group.
The single application of the 25% test-substance concentration at d21 to the animals previously induced with 25% test-substance concentration (test group 2) elicited a statistically significant increase (compared to the vehicle control group) of 3H-thymidine incorporation into the cells of the auricular lymph nodes, which failed to reach the cut-off. A statistically significant (compared to both the vehicle control and challenge control group) just above the cut-off value for auricular
lymph node cell counts was observed. Additonally, a statistically significant (compared to both the vehicle control and challenge control groups) increase of the lymph node weight was noted in this test group.
After the single application of 10%, 5% and 2.5% test-substance concentrations at d21 to the animals to the animals previously induced with 25% test-substance concentration (test groups 3, 4 and 5) no biologically relevant increases in 3H-thymidine incorporation, auricular lymph node cell counts, or lymph node weight was observed. The SI’s were statistically significant (compared to the vehicle control but not the challenge control group) in 3H-thymidine incorporation at 5% and 2.5%, in auricular lymph node cell counts and lymph node weights at 10%, 5% and 2.5%.
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION
CLINICAL OBSERVATIONS:
No signs of systemic toxicity were noticed in all animals during general observation.
BODY WEIGHTS
The expected body weight gain was generally observed during the study.
No local findings were observed during the observation period.
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness).
The test-substance concentrations did not cause an increase (SI ≥ 1.25) in ear weight demonstrating the absence of excessive ear skin irritation. A statistically significant increase was observed in test groups 4 and 5 (compared to both the vehicle control and challenge control groups).
Any other information on results incl. tables
Test Group |
Induction Treatment day 1, 2, 3 |
Challenge Treatment day 21 |
3H-thymidine incorporation Stimulation Index1 |
Cell Count Stimulation Index1 |
Lymph Node Weight Stimulation Index1 |
Ear Weight Stimulation Index1 |
0 |
Vehicle MEK |
Vehicle MEK |
1.00 |
1.00 |
1.00 |
1.00 |
1 |
Vehicle MEK |
25% in MEK |
1.60 # |
1.23 # |
1.26 ## |
1.01 |
2 |
25% in MEK |
25% in MEK |
2.06 # |
1.69 ##, ** |
1.60 ##, * |
1.05 |
3 |
25% in MEK |
10% in MEK |
1.37 # |
1.30 # |
1.40 ## |
1.05 |
4 |
25% in MEK |
5% in MEK |
1.45 # |
1.34 # |
1.43 ## |
1.11 #, ** |
5 |
25% in MEK |
2.5% in MEK |
1.57 # |
1.28 # |
1.36 ## |
1.08 #, ** |
1 test groups 1 to 5 vs. mean of test group 0 (vehicle control)
The statistical evaluations were performed using the WILCOXON-test:
# for p ≤ 0.05, ## for p ≤ 0.01 for comparison vs. mean of test group 0 (vehicle control)
* for p ≤ 0.05, ** for p ≤ 0.01 for comparison vs. mean of test group 1 (challenge control group)
Applicant's summary and conclusion
- Conclusions:
- Thus, it is concluded that 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters did not induce specific lymphocyte proliferation in the Challenge Murine Local Lymph Node Assay (cLLNA) under the test conditions chosen.
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