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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
Endpoint summary
Administrative data
Description of key information
- Acute toxicity: oral: LD50 > 2000 mg/kg bw
- Acute toxicity: dermal: LD50 > 2000 mg/kg bw
- Acute toxicity: inhalation: waiving
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed similarly to the OECD guideline 401 with minor deviation: material tested as a suspension in CMC; it could have been tested undiluted. Certificate of analysis of the test substance is not included, some details on test material and tested animals are missing.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- material tested as a suspension in CMC; it could have been tested undiluted. Certificate of analysis of the test substance is not included, some details on test material and tested animals are missing.
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Average weight : 26 g
- Diet (e.g. ad libitum): Altromin No. 1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): about 50
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The application volume was a constant volume of 20 cm3/kg bw
The test material was suspended in 2% CMC
The concentration of the solution was 99.5 g/L - Doses:
- 1.99 g/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: before administration, 2, 7 and 14 days after administration
- Necropsy of survivors performed: 2 animals - Statistics:
- none
- Preliminary study:
- not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: The following symptoms could be observed: decreased activity, prone position, decreased respiratory rate
- Gross pathology:
- No effect
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, 3,3,5-Trimethylcyclohexyl-ethyl-ether is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS. Oral LD50 males > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study performed similarly to OECD guideline 401, 10 adult male CF-1 mice were administered a single oral dose of test compound suspended in CMC at 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and some of them were necropsied for macroscopic observations.
No mortality was observed. The following symptoms could be observed: decreased activity, prone position, decreased respiratory rate. However, bodyweight increased normally. In these test conditions, oral LD50 in males was considered higher than 2000 mg/kg bw.
Under the test conditions, 3,3,5-Trimethylcyclohexyl-ethyl-ether is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
Table 7.2.1/1 : Mean body weights (g)
Before application |
48 h |
1 week |
2 weeks |
25.8 |
27.02 |
31.35 |
34.69 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed similarly to OECD guideline 401 with only minor deviations therefore considered as appropriate and reliable to complete this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 - 19 November 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline 402 with minor deviations: purity of test item and animal room conditions not reported; 4 females tested instead of 5
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- purity of test item and animal room conditions not reported; 4 females tested instead of 5
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace animals
- Weight at study initiation: 2.2-2.4 kg for males and 2.2-2.5 kg for females
- Housing: Animals were housed individually in suspended wire mesh cages.
- Diet: Fresh Purina rabbit chow (Diet #5321), ad libitum
- Water: Water, ad libitum
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h dark / 12 h light - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: Approximately 10 % of the body surface
- Type of wrap if used: Test item was applied to the prepared dermal site and test site was covered with a gauze patch, secured with non-irritating tape and gentle pressure was applied to the gauze to aid the distribution of the test item over the area. The torso was wrapped with plastic which was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At 24 h after application, the residual test item was gently washed-off with distilled water prior to dermal observations.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): Undiluted
- Constant volume or concentration used: Yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 4 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Test sites were scored for dermal irritation at 24 h post dose and on Days 7 and 14 using the numerical Draize scale. Animals were observed 1, 2 and 4 h post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for 14 days for mortality.
Body weights were recorded pretest, weekly and at death or termination.
- Necropsy of survivors performed: Yes; all animals were examined for gross pathology.
- Other examinations performed: Abnormal tissues were preserved in 10 % buffered formalin for microscopic examination. - Statistics:
- The LD50, 95 % confidence limits, dose response curve and slope were calculated, if possible, by the method of Litchfield and Wilcoxon, 1949.
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: - Diarrhea was the only abnormal physical sign noted during the observation period in one male at Day 6 and one female at Days 2, 3 and 5 after administration - Dermal reactions, well defined on day 1, were absent to slight on Day 7 and absent on Day 14.
- Gross pathology:
- Necropsy results were normal in 7/9 animals. One animal showed slight or scattered white nodules on liver and one animal showed slightly pitted and moderately mottled kidneys.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 for Trimethyl cyclohexyl ethyl ether is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to the Annex VI of the Regulation (EC) N°1272-2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study performed according to OECD Guideline 402 and in compliance with GLP, New Zealand White rabbits (5 males/4 females) were exposed to a single dermal application of Trimethyl cyclohexyl ethyl ether at 2000 mg/kg bw. The test item was applied on dorsal area of the trunk representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality was observed. Diarrhea was the only abnormal physical sign noted during the observation period in one male at Day 6 and one female at Days 2, 3 and 5 after administration. Dermal reactions, well defined on day 1, were absent to slight on Day 7 and absent on Day 14. Body weight changes were normal in 8/9 animals. One male lost weight during the first week of the study. Necropsy results were normal in 7/9 animals. One animal showed slight or scattered white nodules on liver and one animal showed slightly pitted and moderately mottled kidneys. In this study, the dermal LD50 of test item was considered to be higher than 2000 mg/kg bw in rabbits.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study performed similarly to OECD guideline 402 with only minor deviations therefore considered as appropriate and reliable to complete this endpoint.
Additional information
Acute toxicity: oral
In an acute oral toxicity study performed similarly to OECD guideline 401, 10 adult male CF-1 mice were administered a single oral dose of test compound suspended in CMC at 2000 mg/kg bw by gavage. No mortality was observed. The following symptoms could be observed: decreased activity, prone position, decreased respiratory rate. However, bodyweight increased normally. In these test conditions, oral LD50 in male mice was considered higher than 2000 mg/kg bw.
Acute toxicity: dermal
In an acute dermal toxicity study performed according to OECD Guideline 402 and in compliance with GLP, New Zealand White rabbits (5 males/4 females) were exposed to a single dermal application of Trimethyl cyclohexyl ethyl ether at 2000 mg/kg bw. No mortality was observed. Diarrhea was the only abnormal physical sign noted during the observation period in one male at Day 6 and one female at Days 2, 3 and 5 after administration. Dermal reactions, well defined on day 1, were absent to slight on Day 7 and absent on Day 14. Body weight changes were normal in 8/9 animals. One male lost weight during the first week of the study. Necropsy results were normal in 7/9 animals. One animal showed slight or scattered white nodules on liver and one animal showed slightly pitted and moderately mottled kidneys. In this study, the dermal LD50 of the test item was considered to be higher than 2000 mg/kg bw in rabbits.
Acute toxicity: inhalation
No relevant study was available for this endpoint. However, an acute study by inhalation is available (2h at 1%), showing effects that were not of toxicological concern. Moreover, considering that the substance does not induce mortality or systemic effects and is not skin and eye irritant, no respiratory irritation is anticipated that could increase inhalation absorption.
However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity is already provided for the oral and the dermal routes.
Justification for classification or non-classification
Harmonized classification:
The test material has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Self classification:
Based on the available data no additionnal self-classification is proposed regarding:
- both acute oral and dermal toxicity and,
- specific target organ toxicity -single exposure according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- aspiration hazard (based on the acute oral toxicity study)
No reliable data available for acute inhalation toxicity.
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