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EC number: 244-543-3 | CAS number: 21722-83-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 2-cyclohexylethyl acetate
- EC Number:
- 244-543-3
- EC Name:
- 2-cyclohexylethyl acetate
- Cas Number:
- 21722-83-8
- Molecular formula:
- C10H18O2
- IUPAC Name:
- 2-cyclohexylethyl acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The animals were maintained in groups of 3 animals per treatment in polypropylene cage closed with a metallic grid, papered with shavings of Pinnus. Housing hygienic conditions and sanitation cares were in accordance with the patterns advised by SOP-M 0825.
The animals’ rooms were maintained in controlled and monitored environmental conditions during the entire study conduct for: temperature, humidity and room ventilation. Temperature and humidity data were noted in book of records.
Temperature
Min: 19.8 ºC
Max: 23.9 ºC
Humidity
Min: 48 %
Max: 70%
Light cycles
12 hours light / 12 hours dark
Room Ventilation
10 to 15 air changes per hour
Pelleted and commercial diet for rats was provided ad libitum throughout the acclimation and observation periods. Samples of food are regularly assayed for nutritional components and environmental contaminants. Water was provided ad libitum throughout the study, in bottles with metal spouts. For water microbiological analyzes were also performed, and the same quality for human consumption. The results of analyzes of feed and water are kept in the laboratory.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Doses:
- The test was initially conducted with the dose of 300 mg kg-1 of body weight, following the flowchart shown in Appendix 1. This starting dose was based on historical information from studies carried out with the same active ingredient and data from literature. The time interval between treatment groups was determined according to the duration and severity of signs of toxicity.
- No. of animals per sex per dose:
- Twelve rats female (Rattus Norvegicus) young adult lineage Wistar, nulliparous and non-pregnant were used after inspection and acclimation to the laboratory conditions for 5 days.
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Under the test conditions, the test substance Cyclohexyl Ethyl Acetate, when administered by oral route in female rats, did not cause deaths, for every step taken at the dose levels of 300 and 2000 mg kg-1 of body weight.
- Clinical signs:
- other: All the animals exposed to the test substance by the oral route at the doses of 300 and 2000 mg kg-1 of body weight presented no systemic signs of toxicity (Table 2).
- Gross pathology:
- The results of the animals necropsied at study are presented in Table 3.
Any other information on results incl. tables
Table 1 –Individual body weight and quantity of the substance data.
Step |
Dose (mg kg-1) |
Animal # |
Body weight (g) |
Administered quantity (mL) |
Date and hour of application |
|||
Initial (Day 0) |
Day 7 |
Day 14 (Final) |
Difference between final and initial weight |
|||||
1st |
300 |
1 |
200.73 |
217.66 |
218.53 |
17.80 |
0.07 |
19/Dec/2017 08:50 a.m. |
2 |
193.65 |
212.55 |
223.65 |
30.00 |
0.07 |
|||
3 |
205.83 |
224.52 |
227.27 |
21.44 |
0.07 |
|||
2nd |
300 |
1 |
178.93 |
190.76 |
201.36 |
22.43 |
0.05 |
21/Dec/2017 08:20 a.m. |
2 |
185.98 |
203.86 |
213.86 |
27.88 |
0.05 |
|||
3 |
200.72 |
226.93 |
236.18 |
35.46 |
0.06 |
|||
3rd |
2000 |
1 |
227.50 |
229.80 |
237.34 |
9.84 |
0.49 |
26/Dec/2017 10:00 a.m. |
2 |
191.64 |
209.98 |
214.37 |
22.73 |
0.41 |
|||
3 |
189.59 |
197.00 |
206.22 |
16.63 |
0.41 |
|||
4th |
2000 |
1 |
192.76 |
207.31 |
216.03 |
23.27 |
0.41 |
28/Dec/2017 10:00 a.m. |
2 |
204.08 |
210.65 |
220.34 |
16.26 |
0.44 |
|||
3 |
204.26 |
224.95 |
233.60 |
29.34 |
0.44 |
1 mL of sample = 0.8816 g (Mi) (1sttreatment); 1 mL of sample = 1.0314 g (Mi) (2ndtreatment); 1 mL of sample = 0.9320 g (Mi) (3rdtreatment) 1 mL of sample = 0.9299 g (Mi) (4thtreatment)
Equations: (1) Vid= Prx K (2) K = Dose / 106x Mi
Legend: Mi= mass in g of test item Vid: volumen of quantity of test item
Pr: initial animal weight K: constant of multiplication
Table 2 –Behavioral and clinical alterations observed during the experimental period.
Treatment |
Step |
Sex |
Animal # |
observation day |
|||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||
0:30h* |
10:00h |
11:08h |
12:05h |
|
|
|
|
|
|
|
|
|
|
||||||||
300 |
1 |
♀ |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Treatment |
Step |
Sex |
Animal # |
observation day |
|||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||
0:30h* |
09:50h |
10:31h |
14:04h |
|
|
|
|
|
|
|
|
|
|
||||||||
300 |
2 |
♀ |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Treatment |
Step |
Sex |
Animal # |
observation day |
|||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||
0:30h* |
11:00h |
12:30h |
14:05h |
|
|||||||||||||||||
2000 |
3 |
♀ |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Treatment |
Step |
Sex |
Animal # |
observation day |
|||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||
0:30h* |
11:40h |
12:30h |
14:00h |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
2000 |
4 |
♀ |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Legend:
0. none visual alterations observed;
1. Skin, pile and eyes alterations;
2. Mucous membranes alterations;
3. Respiratory system alteration;
4. System circulation alteration;
5. Nervous system alteration;
6. Behavior pattern alteration;
7. Convulsions;
8. Salivation;
9. Diarrhea;
10. Lethargy;
11. Tremble.
Table 3 –Pathological findings in animals at doses of 300 and 2000 mg kg-1of body weight.
Step |
Dose (mg kg-1) |
Animal # |
Macroscopic Alterations |
||||||||||
Skin |
Brain |
Eyes |
Lungs |
Heart |
Liver |
Spleen |
Urinary system |
G.I.T |
R.T |
Carcass |
|||
1st |
300 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2nd |
300 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3rd |
2000 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
4th |
2000 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Legend:
G.I.T – Gastrointestinal tract
R.T – Reproductive tract
0 – Not observed alteration
A – Observed alteration
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance Cyclohexyl Ethyl Acetate, when administered by oral route in female rats, did not cause deaths, for every step taken at the dose levels of 300 and 2000 mg kg-1 of body weight. In clinical examinations, the tested animals did not show systemic signs of toxicity. In macroscopic evaluations no alterations were observed during the necropsies. Based on the flow chart with the starting dose of 300 mg kg-1 of body weight, the test substance was classified as category 5, according to the GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures). The oral LD50 value of test substance Cyclohexyl Ethyl Acetate, for female rats, was estimated to be greater than > 5000 mg kg-1 of body weight.
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