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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]
EC number: 422-040-1 | CAS number: 426218-78-2 CASSIFFIX
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 19 April 1993 and 3 May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]
- EC Number:
- 422-040-1
- EC Name:
- A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]
- Cas Number:
- 426218-78-2
- Molecular formula:
- C16H26O
- IUPAC Name:
- 1-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)-2-oxabicyclo[2.2.2]octane; 3,6',6',6'a-tetramethyl-2',3'a,4',5',6',6'a-hexahydrospiro[cyclohexane-1,3'-cyclopenta[b]fura]-3-ene; 4,6',6',6'a-tetramethyl-2',3'a,4',5',6',6'a-hexahydrospiro[cyclohexane-1,3'-cyclopenta[b]fura]-3-ene; 5-methyl-1-(2,2,3-trimethylcyclopent-3-en-1-yl)-6-oxabicyclo[3.2.1]octane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
The animals were in the weight range of 2.7 to 3.5 kg and approximately 11 to 15 weeks of age, prior to treatment (Day 1) . All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in metal cages with perforated floors in Building R14 Room 5 .
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms.
Results of routine chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd . as quarterly summaries .
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70% .
These environmental parameters were recorded daily . Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear . This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study . Each cage, was identified by a coloured label displaying the study schedule number, animal
number and initials of the Study Director and Home Office licensee .
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal.
- Duration of treatment / exposure:
- Up to 1 hour
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SUBSTANCE PREPARATION
The substance was administered as supplied by the Sponsor. The absorption of the substance was not determined. The homogeneity, stability and purity of the substance were the responsibility of the Sponsor .
TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed (pilot animal see Table 1).
A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
OBSERVATIONS
Clinical signs: All animals were observed daily for signs of ill health or toxicity.
Ocular responses: Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, and 7 days after instillation for two animals and 1 hour and 1,2,3,4, 7 and 14 days after instillation for the remaining animal. Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 1791 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 1789 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 1790 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 1791 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 1789 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 1790 (female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- 1791 (female)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Injected blood vessels on nictating membrane
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- 1789 (female)
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- 1790 (female)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 1791 (female)
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 1789 (female)
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 1790 (female)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- OCULAR RESPONSES
The numerical values given to the ocular reactions elicited by the substance are shown in Table 1 ('Any other informations on results incl. tables').
No corneal damage or iridial inflammation was observed.
A diffuse crimson colouration of the conjunctiva accompanied by slight to obvious swelling was observed one hour after instillation. Ocular reactions had increased in severity one day after instillation, with a diffuse crimson to beefy red colouration with obvious to marked swelling being observed.
Reactions subsequently ameliorated in one animal, resolving fully three days after instillation, but persisted in the two remaining animals with blood vessels of the nictating membrane appearing injected in one animal three days. after instillation.
The eyes of these two remaining animals were normal 7 to 14 days after instillation. - Other effects:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Table 1 Ocular Reactions observed after instillation of the substance
Rabbit no. and sex |
Region of eye |
One hour |
|
|||||||
1 |
2 |
3 |
4 |
7 |
14 |
|||||
1791 female* |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
2^ |
2^ |
2^ |
0 |
|
|
Chemosis |
2 |
3 |
2 |
2 |
2 |
2 |
0 |
|
||
1789 female |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
||
Conjunctiva |
Redness |
2 |
2 |
2 |
0 |
0 |
0 |
- |
|
|
Chemosis |
1 |
2 |
1 |
0 |
0 |
0 |
- |
|
||
1790 female |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
||
Conjunctiva |
Redness |
2 |
3 |
3 |
2 |
2 |
0 |
- |
|
|
Chemosis |
2 |
3 |
3 |
3 |
2 |
0 |
- |
|
* Pilot animal
^ Injected blood vessels on nictating membrane
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye irritant
- Remarks:
- in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance is an eye irritant in an in vivo acute eye irritation study (OECD TG 405). Based on this result, the substance shall be classified as eye irritation category 2, using the phrase: Causes serious eye irritation.
- Executive summary:
The substance was tested in an in vivo acute eye irritation study (OECD TG 405). Three female rabbits were exposed to the substance for a duration of 1 hour using a single application of 0.1 mL. The treatment was followed by an observation period of 14 days. No corneal damage or iridial inflammation was observed. Redness and chemosis were observed (scores 2, 2 and 3 for redness and scores 2, 3 and 3 for chemosis) increasing in severity from 1 hour to 3 days in one animal and from 1 hour to 7 -14 days after installation in the other two animals. There were no signs of toxicity or ill health in any rabbit during the observation period. Based on these results, the substance causes serious eye 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.