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EC number: 612-934-1 | CAS number: 620176-90-1
- 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:
- 2005-01-17 to 2005-02-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.12
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- limited details on test item, test animals and environmental conditions
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one
- Cas Number:
- 620176-90-1
- Molecular formula:
- C11H11FO2
- IUPAC Name:
- 1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-7928531-AAA (T001481)
- Physical state: liquid
- Appearance: Colourless, light yellow to brown liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 17 to 20 g (Main Study)
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary Screening Test: 50 and 100% v/v
Main Study: 10%, 25%, and 50 % v/v - No. of animals per dose:
- Main Study: 4 per dose
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: no data
- Irritation: no data
- Systemic toxicity: No signs of systemic toxicity or weight loss at a concentration of 50% v/v in acetone/olive oil 4:1. A weight loss of 2 g was observed with a concentration of 100% v/v.
- Ear thickness measurements: no data
- Erythema scores: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Stimulation Index of greater than 3.0 indicates a 'positive' result.
TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test substance as a solution in acetone/olive oil 4:1 at concentrations of 10%, 25%, and 50% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS) at 1%, 10%, 20% v/v in 1% pluronic L92 in distilled water
- Statistics:
- no data
Results and discussion
- Positive control results:
- see: any other information on results (here below)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.53
- Test group / Remarks:
- 10% v/v
- Parameter:
- SI
- Value:
- 1.43
- Test group / Remarks:
- 25% v/v
- Parameter:
- SI
- Value:
- 3.54
- Test group / Remarks:
- 50% v/v
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA :
DPM/node obtained by dividing DPM value by 8 (total number of lymph nodes):
Vehicle: 591.85
10% v/v: 904.58
25% v/v: 843.95
50% v/v: 2092.83
DETAILS ON STIMULATION INDEX CALCULATION: see table above
EC3 CALCULATION : The EC3 of the test substance was found to be 43.5%.
CLINICAL OBSERVATIONS: No signs of systemic toxicity were observed in any of the animals tested.
BODY WEIGHTS: no abnormal body weight changes observed in the tested animals
Any other information on results incl. tables
Positive Control Local Lymph Node Assay in the Mouse (2005)
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
04/03/2005 |
10/03/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
2.76, 3.34, 8.91 |
Positive |
20/04/2005 |
26/04/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
ethanol/distilled water |
2.64, 8.36, 12.94 |
Positive |
14/07/2005 |
20/07/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
1% pluronic L92 in distilled water |
0.86, 1.50, 6.17 |
Positive |
14/07/2005 |
20/07/2005 |
2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS) |
1%, 10%, 20% v/v |
1% pluronic L92 in distilled water |
1.16, 9.59, 20.71 |
Positive |
a= Ratio of test to control lymphocyte proliferation
b= Stimulation index greater than 3.0 indicates a positive result
* = Standard Test Method 595 (Pooled nodes)
·= Standard Test Method 599 (Individual nodes)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Since there was indication that the test item elicited a SI ≥ 3 when tested up to 50%, T001481 was considered to be a skin sensitizer. As the EC3 value was > 2% (i.e. 43.5%), the substance is classified as skin sensitizer category 1B according to the criteria of the CLP Regulation (H317).
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