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EC number: 604-669-5 | CAS number: 149021-58-9
- 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:
- 2008-01-22 to 2008-05-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to OECD TG No.429 and in compliance with GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-propylheptyl acrylate
- EC Number:
- 604-669-5
- Cas Number:
- 149021-58-9
- Molecular formula:
- C13 H24 O2
- IUPAC Name:
- 2-propylheptyl acrylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: 2-Propylheptylacrylat rein
-Test substance number: 07/0846-1
- Analytical purity: 98.5 area-%
- Isomers composition: about 87 % 2 Propylheptylacrylate and 10 % 4-methyl-2-propylhexylacrylate
- Analytical report no.: 07L00384
- Lot/batch No.: B4112/13 - 03122007
- Expiration date of the lot/batch: 2008-12-03
- pH-value: Ca. 5.5 (undiluted test substance)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Mouse / CBA/J from Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6 – 12 weeks
- Weight at study initiation: 18.3 g – 21.4 g
- Housing:single housing, Makrolon cage, type II
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: 13 days before the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Study design: in vivo (LLNA)
- Vehicle:
- other: AOO 4:1 (mixture of acetone:olive oil Ph.Eur./DAB in a ratio 4:1 parts by volume)
- Concentration:
- 3%, 10%, 30% test substance solution (w/w) in AOO
- No. of animals per dose:
- 4 animals in control group, 5 animals in test groups
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The increase SI of cell count by a factor of >1.5 and/or of 3H-thymidine incorporation by a factor of ≥ 3 as compared to the concurrent vehicle control group is generally considered as indicating a sensitizing potential of a test substance.
TREATMENT PREPARATION AND ADMINISTRATION:
-Randomization: Prior to first application, the animals were distributed to the individual groups, received their animal numbers and were allocated to the respective cages.
-Body weight determination: Individual body weights on day 0 prior to the first application and on day 5 prior to the sacrifice of the animals.
-Signs and symptoms: No detailed clinical examination of the individual animals was performed but any obvious signs of systemic toxicity and/or loc
al inflammation at the application sites were noted in the raw data.
-Form of application:
Epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
-Application volume:
25 μL per ear
-Site of application:
Dorsal part of both ears
-Frequency of application:
3 consecutive applications (day 0 – day 2) to the same application site
-Selection of doses:
The selection of vehicle and concentrations takes into account available information on the chemical/physical properties and the composition of the test substance. In addition the results of a pretest with a 50% test-substance preparation in AOO were considered, which showed slightly increased ear weights and increased lymph node weights as indication of ear irritation. Additionally the 50% preparation caused slight scaling on the backside of the ears.
-Mortality check:
Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
-3H-Thymidine injection:
On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H
-thymidine in 250 μL of sterile saline into the tail vein. The animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation.
-Determination of ear weight: Immediately after the death of each animal a circular piece of tissue (diameter 0.8 cm) was punched out of the apical part of each ear of all animals. The weight of the pooled punches was determined for each test group. These measurements serve for detecting a potential inflammatory ear swelling.
-Removal and weight determination of the lymph nodes:
Immediately after removal of the ear punches the left and right auricular lymph nodes were dissected. The weight of the pooled lymph nodes from both sides was determined for each animal.
-Determination of cell count was performed by electronic measurement with a Casy(R)-Counter.
-Measurement of 3H-thymidine incorporation of the lymph node cells:
The remaining cell suspensions were washed twice with phosphate buffered saline (PBS) and precipitated with 5% trichloro-acetic acid (TCA). Each precipitate was transferred to scintillation fluid and incorporation of 3H-thymidine into the cells was measured in a ß-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Calculation of EC (estimated concentration leading to the respective SI values): calculation by linear or semi-logarithmical regression between the data points directly below and above the SI if possible or using the two nearest points below or above the SI.
Results and discussion
- Positive control results:
- Stimulation index cell counts (1%, 3%, 10%): 1.10, 1.34, 1.77
Stimulation index 3H-thymidine incorporation (1%, 3%, 10%): 1.84, 2.35, 3.26
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation index cell count (3%, 10%, 30%): 0.95, 1.05, 1.36. Stimulation index 3H-thymidine incorporation (3%, 10%, 30%): 1.27, 1.81, 3.29. The estimated concentration that leads to the SI of 1.5 for cell count (EC 1.5) and the estimated concentration that leads to the SI of 3.0 for 3H-thymidine incorporation (EC 3) were calculated by linear regression from the results of the 30% and 10% concentration to be 38.8% and 26.1%, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM were 609 in the vehicle control and increased to 2002.6 in the group treated with 30% test substance (for details see Table 1).
Any other information on results incl. tables
Table 1: 3H-Thymidine incorporation: test group mean values and stimulation indices.
Test group |
Treatment |
3H-thymidine incorporation |
|
|
|
(DPM/lymph node pair) |
Stimulation index |
1 |
Vehicle AOO |
609.0 |
1 |
2 |
3% in AOO |
770.8 |
1.27 |
3 |
10% in AOO |
1105.0 |
1.81 |
4 |
30% in AOO |
2002.6 |
3.29 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
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