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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 14 April 1993 and 17 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA is not performed because other reliable information is available.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Fifteen healthy female nulliparous and non-pregnant albino guinea-pigs of the Dunkin/Hartley strain were obtained from D. Hall, Newchurch, Staffordshire, England.
The animals were in the weight range of 325 to 366 g on arrival and approximately six to seven weeks of age. All the guinea-pigs were acclimatised to the experimental environment for 12 days prior to allocation to the main study.
An additional six animals, from the same supplier, were used for the preliminary investigations
The animals on the main study were allocated without conscious bias to two groups as follows:
Group │Number of animals │ Animal numbers
Control animals │ 5 │ 1275 to 1279
Test animals │ 10 │ 1290 to 1299
The guinea-pigs were housed in groups of ten in suspended metal cages with wire mesh floors in Building R17 Room 13.
A vitamin C enriched guinea-pig diet FD 1 and drinking water were provided ad libitum. Hay was given weekly.
The batch of diet used for the study was not analysed for nutrients, possible contaminants or microorganisms.
However, other batches of diet are periodically tested, by the Supplier, and were found to be within the set limits.
Results of routine physical and 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 21°C and relative humidity at 30 - 70% .
These environmental parameters were recorded daily. Air exchange was maintained at approximately 15 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 ear tattoo number. 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 schedul enumber, animal numbers and the initials of the Study Director and Home Office licensee.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Intradermal injection: 7.5% (v/v) in Alembicol D
Topical application: as supplied - Day(s)/duration:
- Topical application: 48 hours
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- As supplied and 50% v/v in Alembicol D
- No. of animals per dose:
- 10 animals for the main test, 5 control animals
- Details on study design:
- Preliminary study
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
Selection of concentrations of test substance for the main study
Based on the results of the preliminary investigations, the following concentrations of the substance were selected:
Induction intradermal injection - 7. 5% v/v in Alembicol D
Induction topical application - as supplied
Topical challenge - as supplied and 50% v/v in Alembicol D
Main study
The procedure may be considered in two parts, Induction and Challenge.
Induction
Induction intradermal injections - test animals
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 2 x 4 cm area within the clipped area.
Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (ph.Eur.) .
2. Test substance, 7.5% v/v in Alembicol D.
3. Test substance, 7.5% v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
Induction topical application - test animals
The preliminary investigations indicated that the maximum practical concentration of the test substance for topical application (as supplied) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.2 mI per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 x 40 mm patch of What man No. 3 paper was saturated with approximately 0.4 ml of the substance, as supplied. The patch was placed on the skin <;If the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm").
This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
Induction - control animals
During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
Challenge
Challenge - control and test animals
The control and test animals were challenged topically two weeks after the topical induction application using the test substance, as supplied and 50% v/v in Alembicol D.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig.
A 20 x 20 mm patch of Whatman No. 3 paper was saturated with approximately 0.2 ml of the substance, as supplied and applied to an anterior site on the flank. The test substance, 50% v/v in Alembicol D was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek" .
OBSERVATIONS
Clinical signs: All animals were observed daily for signs of ill health or toxicity.
Bodyweight: The bodyweight of each guinea-pig on the main study was recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge applications.
Dermal responses: The dermal reactions resul ting from intradermal injection and topical application on the preliminary study, and topical application at the challenge were assessed using the following numerical system. - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in one animal
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in one animal
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- The substance as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50% v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- As supplied
- No. with + reactions:
- 29
- Total no. in group:
- 30
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Remarks:
- in accordance with EU CLP (1272/2008 and its amendments)
- Conclusions:
- The substance is not a skin sensitiser in the Guinea Pig Maximisation Test (OECD TG 406).
- Executive summary:
The substance was tested in a guinea pig maximisation test (OECD TG 406) using ten animals and five control animals. The concentrations were selected based on the results of a preliminary study. In the induction phase, the substance was tested both through intradermal injections at a concentration of 7.5% in Alembicol D as well as through topical application using the test substance as supplied. In the challenge phase, the substance was tested as supplied and at a concentration of 50% in Alembicol D. No signs of illness or toxicity were observed. Bodyweight increased as expected during the period of the study. In the induction phase, necrosis was observed in both test and control animals after intradermal injections of Freund's Complete Adjuvant. Slight irritation was seen in test animals after receiving the test substance, 7.5% v/v in Alembicol D and very slight irritation was seen in control animals after receiving Alembicol D without test substance. Topical application of the substance as supplied resulted in very slight erythema in test animals. Slight erythema was also observed in control animals. In the challenge phase, no reactions were observed in any of the test or control animals except for dryness and sloughing of the epidermis in one test animal 48 and 72 hours after the challenge phase. The degree and duration of this reaction was not considered to represent evidence of skin sensitisation. Based on the results obtained in this study, the substance is not sensitising to the skin.
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