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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-792-4 | CAS number: 696-29-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-10-04 to 2011-11-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 2008
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 2011 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- Isopropylcyclohexane
- EC Number:
- 211-792-4
- EC Name:
- Isopropylcyclohexane
- Cas Number:
- 696-29-7
- Molecular formula:
- C9H18
- IUPAC Name:
- (propan-2-yl)cyclohexane
- Test material form:
- liquid
- Details on test material:
- purity 99.93 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley
- Source: Charles River Laboratories, Germany
- Sex: male
- Age: 32 days at arrival + approx. 2 weeks for acclimatization and pilot study
- Weight at study initiation: 318 - 399 g
- Housing: in pairs in MAKROLON cages
Environmental conditions: - Feed: Commercial diet, ssniff Ms-H V 2233
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 3°C)
- Humidity: 55% (+/- 15%)
- Illumination: 12 hour light/dark rhythm
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- 1st application: Induction 10 % intracutaneous in sesame oil
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 75 % occlusive epicutaneous in sesame oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- 1st application: Induction 10 % intracutaneous in sesame oil
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 75 % occlusive epicutaneous in sesame oil
- No. of animals per dose:
- 10 animals preliminary study
10 animals vehicle control
20 animals test item - Details on study design:
- ADMINISTRATION/EXPOSURE
- Preliminary study: Six concentrations of Isopropylcyclohexane were tested by intracutaneous injection: 0.01, 0.1, 0.5, 1, 5 or 10% solutions in
sesame oil: No skin reactions were observed up to the concentration of 5%. A concentrations of 10% revealed a discrete or patchy erythema 24, 48 and 72 hours after administration.
Seven concentrations of Isopropylcyclohexane were tested by topical application: 1, 5, 10, 25, 50 and 75% solutions in sesame oil and the undiluted test item.
No skin reactions were observed at any concentration to the non-depilated skin
No skin reactions were observed up to the concentration of 75%. The undiluted test item revealed a discrete or patchy erythema 48 and 72 hours
after start of exposure to the depilated skin
Hence, it was decided to use a 10% concentration in sesame oil for the 1st (intracutaneous) stage, the undiluted test item for the 2nd (topical)
induction stage and a 75% solution in sesame oil for the challenge.
MAIN STUDY
- Preparation of test substance for induction: Mixing with vehicle
Stage 1 (induction)
- Induction schedule:
Day 0: Injections
Injection details: 0.1 ml each at 6 positions in clipped scapular region:
2 x Freund's Complete Adjuvant (FCA) emulsified with 0.9% NACl (50:50)
2 x test substance 10 % in vehicle
2 x test item in a 1:1 mixture (v/v) FCA/physiological saline
pairwise and symmetrical administration of each solution / suspension
controls: vehicle instead of test substance
Day 6: Clipping of hair in injection sites and treatment with 0.5 ml of 10 % sodium laurylsulfate in vaseline
Stage 2 (induction)
Day 7: 48 hours occlusive patch with 100 % test substance (controls: vehicle) on injection sites
Stage 3 (challenge)
- Challenge schedule:
Day 21: 24 hours occlusive patches on clipped flanks with 2 mL of a 75% solution of Isopropylcyclohexane in sesame oil/animal. The filter paper
containing the test item was applied to the left flank, the filter paper with the vehicle to the right flank of the animal. 21 hours after the filter paper
had been removed, no cleaning of the treated skin was necessary
Days 23 and 24:
- 21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary
- three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded
- 24 hours after this observation a second observation (72 hours) was made and recorded.
- Rechallenge: no
- Positive control: a-hexyl cinnamic aldehyde - positive control group was not tested concurrently with this study but is a historical background
group from a study performed during October/November 2011.
Other observations
Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination - Challenge controls:
- filter paper with the vehicle to the right flank of the animal
- Positive control substance(s):
- yes
- Remarks:
- a-hexyl cinnamic aldehyde - positive control group was not tested concurrently with this study but is a historical background group from a study performed during October/November 2011.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% Isopropylcyclohexane
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75% Isopropylcyclohexane. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 75% Isopropylcyclohexane
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 75% Isopropylcyclohexane. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Flow chart of study design:
|
Main experiment
|
|||||
day 0 (induction) |
day 7 (induction) |
day 21 (challenge) |
day 23 +45 h# |
day 23 +48 h# |
day 24 +72 h# |
|
Shaving |
x |
x |
x |
|
|
|
Depilation |
|
|
x |
|
|
|
Application of test formulation |
x |
x |
x |
|
|
|
Cleaning |
|
after patch removal x |
|
x |
|
|
Evaluation of skin |
24 h + 48 h after start of exposure x |
48 h and 72 h after start of exposure x |
|
|
x |
x |
Mortality |
x |
x |
x |
x |
x |
x |
Clinical signs |
x |
x |
x |
x |
x |
x |
Body weight |
x |
|
|
|
|
x |
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions the test item was found to be not sensitising to guinea pigsin a test model according to
MAGNUSSON and KLIGMAN. - Executive summary:
The purpose of this study was to determine the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.
A 10% solution of isopropylcyclohexane in sesame oilchosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 20 animals 24 and 48 hours after administration.
2 mL of the undiluted test item/animal chosen for the 2nd (topical) induction stage were not irritating to the shaved skin in the preliminary experiment.
Hence, in the main study the skin was coated with sodium laurylsulfate on the day before stage 2 induction in order to induce a local irritation. This treatment resulted in a moderate and confluent erythema or a discrete or patchy erythema in all test group animals 48 or 72 hours after start of exposure.
The challenge with 2 mL of a 75% solution of isopropylcyclohexane in sesame oil/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties.
The vehicle control revealed no skin reactions.
Animals of the same strain treated with a-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of
a discrete or patchy erythema (grade 1).
Behaviour of the animals remained unchanged.
Under the present test conditions, the test item was found to be not sensitising to guinea pigsin a test model according to MAGNUSSON and KLIGMAN.
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.