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EC number: 204-373-2 | CAS number: 120-14-9
- 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:
- 3-10 September 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation, other
- Remarks:
- Read-across
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information is derived from read across
- Justification for type of information:
- The full read-across document can be found in the Endpoint Summary and also the accompanying files.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- EC3
- Remarks:
- %
- Value:
- 25
- Interpretation of results:
- other: Skin sensitising (category 1B)
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- Based on the data available it can be concluded that the substance is a skin sensitiser.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Piperonal
- EC Number:
- 204-409-7
- EC Name:
- Piperonal
- Cas Number:
- 120-57-0
- Molecular formula:
- C8H6O3
- IUPAC Name:
- 1,3-benzodioxole-5-carbaldehyde
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME 04609
- Age at study initiation: 9 weeks
- Specification: purpose-bred and experimentally naive at the outset of the study
- Weight at study initiation: 18 - 24 g (on initial dose day)
- Housing: Group housed 5 per cage
- Diet: Free access to Harlan Teklad Certified Rodent Chow 7012C
- Water: Free access to tap water
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 22 - 25.6
- Humidity (%): 21 - 48
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: EtOH/DEP
- Concentration:
- The test item at concentrations of 1, 2.5, 5, 10 and 25% w/v in the vehicle.
- No. of animals per dose:
- 5
- Details on study design:
- A range finding test was not conducted for this study. The doses were selected so that the highest concentration maximizes exposure while avoiding systemic toxicity and excessive local irritation. Doses were selected based on known reported uses of the material.
TREATMENT PROCEDURES:
TOPICAL APPLICATION:
On Days 1, 2 and 3, each test animal in its group received an open application of 25 ul of an appropriate dilution of test item in vehicle to the dorsum of both ears. The positive control group (5 females) was treated with hexylicinnamaldehyde. All test and control animals were given a two-day rest period on Days 4 and 5.
ADMINISTRATION OF 3H-METHYL THYMIDINE:
On Day 6 of the study, all test and control animals were injected i.v. with 20 uCi of 3H-Thymidine in sterile saline. Five hours after injection, animals were sacrificed and the draining auricular lymph nodes excised.
DETERMINATION OF INCORPORATED 3HTdR:
The lymph nodes from each group were pooled and a single cell suspension was prepared. Cells were washed twice with PBS and precipitated with 5% trichloroacetic acid overnight at 2-8°C. The pellets were resuspended in 1 mL of TCA and transferred to a vial containing scintillation fluid. Incorporation of tritiated thymidine was measured by liquid scintillation counter.
OBSERVATIONS:
Individual body weights were recorded on Day 1 prior to dosing and Day 6 prior to injection. All test and control animals were observed daily for mortality and any excessive irritation at the test site. Clinical observations ere performed daily on day 4-6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- DPM for each group was determined. Increases in 3H-thymidine incorporation relative to the vehicle-treated control was derived for each group.
Results and discussion
- Positive control results:
- The positive control item, hexyl cinnamic aldehyde, at 5%, 15% and 35% gave a Stimulation Index of 5.5, 6.1 and 19.5, respectively.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Remarks:
- %
- Value:
- 25
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 1, 2.5, 5, 10 and 25% were 1.1, 1.9, 2.2, 2.1 and 3.0, respectively.
Any other information on results incl. tables
Results:
Animal group |
Test item concentration |
Average DPM count |
SI (test / control ratio) |
Results |
Vehicle control |
- |
965.8 |
|
- |
Test group I |
1% |
1069.7 |
1.1 |
- |
Test group II |
2.5% |
1843.3 |
1.9 |
- |
Test group III |
5% |
2160.2 |
2.2 |
- |
Test group IV |
10% |
2001.4 |
2.1 |
- |
Test group V |
25% |
2910.7 |
3.0 |
+ |
Positive control I |
5% |
5273.2 |
5.5 |
+ |
Positive control II |
15% |
5936.3 |
6.1 |
+ |
Positive control III |
35% |
18853.7 |
19.5 |
+ |
VIABILITY / MORTALITY:
There was no mortality throughout the study.
CLINICAL SIGNS:
All animals appeared normal for the duration of the study. No erythema or edema was seen in any of the animals during the study. On day 3, three out of 5 mice from the vehicle control group and 2 out of 5 mice from the 25% test material treatment group had ears that appeared wet. Furthermore, on days 2 -5, mice in the positive control groups had ears that appeared wet.
BODY WEIGHTS:
There were no statistically significant differences observed between any of the treatment groups.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitising (category 1B)
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- The SI values calculated for the substance concentrations 1, 2.5, 5, 10 and 25% were 1.1, 1.9, 2.2, 2.1 and 3.0, respectively. These results show that the test substance could elicit a SI ≥ 3. An EC3 has been derived resulted in an EC3 of 25%. The test substance was considered to be a sensitiser under the conditions of the test.
- Executive summary:
The skin sensitisation potential of the substance has been tested according to OECD TG 429 and GLP principles. At 1, 2.5, 5, 10 and 25% the substance showed SI values of 1.1, 1.9, 2.2, 2.1 and 3.0, respectively. Reliable negative and positive controls were included. All animals appeared normal for the duration of the study.
These results show that the test substance could elicit a SI ≥ 3. An EC3 has been derived of 25%.
Based on the results, the substance is considered to be a skin sensitiser.
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