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EC number: 833-005-9 | CAS number: 1003218-33-4
- 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:
- Mar 06, 2020 - May 26, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This substance was notified under MEP Order No. 7 in China as regular registration of a new chemical substance. The regular registration under MEP Order No. 7 does not accept in vitro alternative methods to access skin sensitization but requires in vivo data. Therefore, the OECD 429 assay was performed to comply with this regulatory requirement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene
- EC Number:
- 833-005-9
- Cas Number:
- 1003218-33-4
- Molecular formula:
- C24H34F2O
- IUPAC Name:
- 1-butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Inbred, SPF-Quality
- Age at study initiation: 10 weeks
- Weight at study initiation: Pre-test and Main test: 20.1 to 24.0 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 39 - 43 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 6
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, and 25% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Two test item concentrations were tested; a 10% and 25% concentration. The highest
concentration was the highest concentration that could be prepared homogeneously.
At a 10 and 25% test item concentration, no signs of systemic toxicity were noted and only
very slight irritation was observed in the 25% test item group. Therefore, a 25% concentration
was selected as highest concentration for the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
- Positive control results:
- Conc. SI
0%: 1.0
5% 1.3
10% 3.4
25% 5.5
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Test Group: 5% in AOO
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Test Group: 10% in AOO
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- Test Group: 25% in AOO
Any other information on results incl. tables
Calculation of Stimulation Indices per Dose Group
Test item concentration |
Group Calculation |
||
Mean DPM per animal (2 lymph nodes) |
SD |
S.I. |
|
AOO (Vehicle Control) |
310 |
49 |
1.0 |
5 % Test Item in AOO |
262 |
47 |
0.8 |
10 % Test Item in AOO | 260 |
43 |
0.1 |
35 % Test Item in AOO | 190 |
39 |
0.1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test item does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
- Executive summary:
Objective
The objective of this study was to evaluate whether the test material induces skin sensitization in mice after three epidermal exposures of the animals under the conditions described in this report.
Study Design
The study was carried out based on the guidelines described in:
• OECD, Section 4, Health Effects, No.429 (2010).
• EC No 640/2012, Part B: "Skin Sensitization: Local Lymph Node Assay".
• EPA, OPPTS 870.2600 (2003) “Skin Sensitization”.
Test item concentrations selected for the main study were based on the results of a pre-screen test. Based on the results, the highest concentration required according to the guidelines was selected.
In the main study, three experimental groups of five female CBA/J mice were treated with test item concentrations of 5, 10 or 25% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive Oil, AOO). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.
Results
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. Mean DPM/animal values for the experimental groups treated with test item concentrations 5, 10 and 25% were 262, 260 and 190 DPM, respectively. The mean DPM/animal value for the vehicle control group was 310 DPM. The SI values calculated for the test item concentrations 5, 10 and 25% were 0.8, 0.8 and 0.6, respectively. Since there was no indication that the test item elicits a SI = 3 when tested up to 25%, the test material was considered not to be a skin sensitizer. It was established that the EC3 value (the estimated test item concentration that will give a SI =3) (if any) exceeds 25%.
Conclusion
Based on these results, the test material would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test item does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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