Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-722-5 | CAS number: 67583-77-1
- 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:
- 16 December 2015 to 12 January 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD test Guideline No. 429 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspected on June 17, 2015 / signed on September 24, 2015)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-ethoxy-1,1,5-trimethylcyclohexane
- EC Number:
- 266-722-5
- EC Name:
- 3-ethoxy-1,1,5-trimethylcyclohexane
- Cas Number:
- 67583-77-1
- Molecular formula:
- C11H22O
- IUPAC Name:
- 3-ethoxy-1,1,5-trimethylcyclohexane
- Test material form:
- liquid
- Details on test material:
- - Physical state/Appearance: Clear colorless liquid
- Storage condition of test material: Stored at room temperature in the dark
- Expiration date of the lot/batch: 09 July 2016
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc., Horst / The Netherlands.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Animals were housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK), ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: ca. 15 air changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 16 December 2015 to 12 January 2016
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25 and 50% in acetone/olive oil 4:1 and 100%
- No. of animals per dose:
- 4 females/dose
- Details on study design:
- TEST ITEM PREPARATION
For the purpose of the study, the test item was used undiluted and freshly prepared as a solution in acetone/olive oil 4:1. The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
PRE-SCREEN TESTS:
- Using available information regarding the irritancy potential of the test item, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 μL of the undiluted test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Local skin irritation was scored daily and any clinical signs of toxicity, if present, were also recorded. The body weight was recorded on Day 1 (prior to dosing) and on Day 6.
- Ear thickness measurements: The thickness of each ear was measured using a Mitutoyo 547-300S gauge (Mitutoyo Corporation), pre-dose on Day 1, post dose on Day 3 and on Day 6. Any changes in the ear thickness were noted. Mean ear thickness changes were calculated between time periods Days 1 and 3 and Days 1 and 6. A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitization.
Results: No signs of systemic toxicity and no local skin irritation (no increase in mean ear thickness greater than 25%) were noted. Based on this information the undiluted test item and the test item at concentrations of 50% and 25% v/v in acetone/olive oil 4:1 were selected for the main test.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer".
TREATMENT PREPARATION AND ADMINISTRATION:
The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). A further group of four mice received the vehicle alone in the same manner. Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 μL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 μCi to each mouse. Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation followed by cervical separation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.
A single cell suspension of pooled lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless steel gauze (200 mesh size). The LNC were then washed by adding PBS, pelleted at 1400 rpm for 10 minutes and resuspended. The cells were washed twice again and resuspended in 3 mL trichloroacetic acid (TCA: 5%) following the final wash. After ca 18 hours with 5% TCA at 4 °C, the precipitate was recovered by centrifugation and resuspended in 1 mL 5% TCA and transferred to 10 mL scintillation fluid. The 3HTdR incorporation was measured by β scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per minute per lymph node (dpm/node). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI for the positive control substance α-Hexylcinnamaldehyde, tech., 85%, was 6.08 considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 2.09
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 3.27
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- DISINTEGRATIONS PER MINUTE/NODE: 2681.20, 2451.46, 5594.38 and 8767.15 for Vehicle, 25, 50 and 100%, respectively
STIMULATION INDEX: 0.91, 2.09 and 3.27 for 25, 50 and 100%, respectively
EC3 CALCULATION: EC3 = 50 + [[(3−2.09)/(3.27−2.09)] x (100−50)] = 89
The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 89%.
CLINICAL OBSERVATIONS:
- There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS
- Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Any other information on results incl. tables
Table 7.4.1/1: Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% v/v) in acetone/olive oil 4:1 |
dpm |
dpm/nodea |
Stimulation Indexb |
Result |
Vehicle |
21449.58 |
2681.20 |
NA |
NA |
25 |
19611.70 |
2451.46 |
0.91 |
Negative |
50 |
44755.07 |
5594.38 |
2.09 |
Negative |
100 |
70137.23 |
8767.15 |
3.27 |
Positive |
dpm = Disintegrations per minute
a = Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
NA = Not applicableApplicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions, test item is classified as a skin sensitiser according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
A study was performed to assess the skin sensitisation potential of test item in the CBA/CaOlaHsd strain mouse following topical application to the dorsal surface of the ear. The method was conducted according to the OECD test guideline No 429 and in compliance with GLP.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.
Disintegrations per minute/node for Vehicle, 25, 50 and 100% were 2681.20, 2451.46, 5594.38 and 8767.15, respectively. Stimulation Indices (S.I.) of 0.91, 2.09 and 3.27 for 25, 50 and 100%, respectively. The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 89%.
SI for the positive control substance 25% hexyl cinnamic aldehyde (HCA), was 6.08 which demonstrates the validity of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.