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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 216-835-0 | CAS number: 1678-91-7
- 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 eye irritation in vivo:
After administration of a single dose of 0.1 mL of the test material into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated. Signs of irritation in unwashed eyes and washed eyes were limited to slight erythema of the conjunctivae and nictitating membranes one hour after administration of the test material. At the time of examinations on the day following dosing, all eyes in both groups (unwashed and washed) appeared clinically normal. When unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material, corneal and adnexal staining were not evident. No other signs of irritation were noted during the 72-hour observation period. Immediate irrigation of the eyes had no effect on the minimal irritation responses
observed. No non-ocular effects were noted for unwashed or washed eyes during the observation period.
Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes".
Acute skin irritation in vivo:
A dose of 0.5 mL of the test material was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of four hours. No signs of irritation or abnormal clinical signs were observed at any time during the study. All animals survived the 14-day observation period, and all gained weight normally. Based on weight gain and survival rate, there was no evidence of percutaneous absorption.
Based on the lack of an irritant response, the test material was classified as "not irritating to skin".
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-01-14 - 1992-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or test system and environmental conditions:
- Source: Hazleton Research Laboratories, Denver, PA, USA
No. of Animals: 3
Sex: Not Determined
Body Weight Range at Dosing (grams): 3477 - 3572
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 a.m. to 6 p.m. Room temperature was maintained at 70-74°F. Relative humidity was maintained at 41-52%.
Diet andWater: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The hair was removed from an area of the dorsal skin with an electric clipper. A single dose of the material was placed in contact with the sin using a fiber pad and an occlusive wrap to hold the test material in place for four hours. At the end of the exposure period, the application site was rinsed with running water.
The site of application was examined at 1, 24, 48 and 72 hours, and 7 and 14 days after removal of the occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and staining caused by the material as well as general systemic effects.
Animals were weighed at initiation of the study (Day 0), on Day 7, and at termination of the 14-day observation period.No necropsies were conducted at the conclusion of the 14-day observation period. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the lack of an irritant response, the test material was classified as "not irritating to skin".
- Executive summary:
A dose of 0.5 mL of the test material was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of four hours. No signs of irritation or abnormal clinical signs were observed at any time during the study. All animals survived the 14-day observation period, and all gained weight normally. Based on weight gain and survival rate, there was no evidence of percutaneous absorption.
Based on the lack of an irritant response, the test material was classified as "not irritating to skin".
Reference
Clinical observations graded as described in OECD Guideline 404 (erythema, edema)
ANIMAL NUMBER |
DOSE <mL) |
RESPONSE AT THE SITE OF APPLICATION |
|||||
1HOUR |
24HOURS |
48HOURS |
72HOURS |
7DAYS |
14DAYS |
||
797 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
798 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
799 |
0.5 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-01-21 - 1992-03-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SRID or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid - Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or tissues and environmental conditions:
- Source: Hazleton Research Animals, Denver, PA, USA
No. of Animals: 6; 3 Washed/3 Unwashed
Sex: Not Determined
Body Weight Range at Dosing: Not Determined
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 am. to 6 p.m. Room temperature was maintained at
70-74°F. Relative humidity was maintained at 48-51%
Diet and Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0. 1 mL/eye
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Both eyes of each rabbit selected for the study were tested with fluorescein dye and examined within 24 hours of administering the test material. Animals showing eye irritation, ocular defects, or pre-existing corneal injury were not used.
A single dose of the material was placed into the conjunctival sac of one eye of each animal. Three of the eyes were immediately washed with running distilled water; the other three eyes were not irrigated.
Clinical Observations:
Eyes were observed immediately after instillation of the test material and 1, 24, 48, and 72 hours thereafter. Observations included indications of immediate sensory irritation and estimations of edema and erythema of the cornea and adnexal structures. Also evaluated were effects on the iris, the presence of corneal opacity and/or discharge from the eye. Eyes were treated with a 2% ophthalmic solution of fluorescein at 24 hours and observed for staining.
Body Weight Determinations:
Animals were not weighed as weights are not critical to this study.
Necropsy:
No necropsies were conducted at the conclusion of the test. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"
- Executive summary:
After administration of a single dose of 0.1 mL of the test material into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated. Signs of irritation in unwashed eyes and washed eyes were limited to slight erythema. of the conjunctivae and nictitating membranes one hour after administration of the test material. At the time of examinations on the day following dosing, all eyes in both groups (unwashed and
washed) appeared clinically normal. When unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material, corneal and adnexal staining were not evident. No other signs of irritation were noted during the 72-hour observation period. Immediate irrigation of the eyes had no effect on the minimal irritation responses
observed. No non-ocular effects were noted for unwashed or washed eyes during the observation period.
Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"
Reference
Description of Other Serious Ocular Lesions. Including Fluorescein Staining No other serious ocular lesion was noted during the study. Corneal and adnexal staining were not evident when unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material. Description of Non-Ocular Effects
No non-ocular effects were observed.
ANIMAL NUMBER |
IRRIGATED |
EFFECTS (Corneal Opacity,Iris Effects,Erythema,Chemosis) |
|||
1Hour |
24Hours |
48Hours |
72Hours |
||
803 |
No |
0,0,1,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
804 |
No |
0,0,1,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
805 |
No |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
806 |
Yes |
0,0,1,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
807 |
Yes |
0,0,1,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
808 |
Yes |
0,0,1,0 |
0,0,0,0 |
0,0,0,0 |
0,0,0,0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Acute eye irritation:
The respective criteria are not met. Ethylcyclohexane has not to be classified for eye irritation.
Acute skin irritation:
The respective criteria are not met. Ethylcyclohexane has not to be classified for skin irritation.
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.