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Diss Factsheets
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EC number: 916-331-7 | CAS number: -
- 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:
- 23 Jan 1978 - 15 Feb 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to Modified Federal Hazardous Substance labelling Act Method (similar to OECD 405), but not under GLP-conditions.
- Justification for type of information:
- Results are from an in vivo test conducted before the Reach Regulation came into force requesting in vitro information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- additionally, the area of cornea and iris affected was measured.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- EC Number:
- 916-331-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Morton Commascidand S Colworth rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Age: approximately 8 weeks old.
ENVIRONMENTAL CONDITIONS
No data available.
IN-LIFE DATES: From: 23 January 1978 To: 7 February 1978 (?)
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test substance used as supplied.
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- No data available.
- Observation period (in vivo):
- Assessment of ocular damage was made approximately 15 minutes, 4 hours after exposure and daily thereafter until 11 days and after 15 days. Animals were only assessed at these time points if ocular damage was present at the previous assessment.
- Number of animals or in vitro replicates:
- In total 13 animals were used: 7 animals were treated (one eye per animal), 6 animals were used as control.
- Details on study design:
- A drop of local anesthetic (amethocaine hydrochloride) was placed in each eye prior to application of the test substance to prevent discomfort.
REMOVAL OF TEST SUBSTANCE
Not applicable
SCORING SYSTEM:
Scoring system in accordance with Modified Federal Hazardous Substances Labelling Act Method. Additionally, area of affected cornea and iris was assessed.
TOOL USED TO ASSESS SCORE: Slit lamp
Controls: Tween 80 was used as negative control substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.93
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.48
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.62
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.62
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Cyclabute, as supplied, caused slight to moderate corneal lesions affecting up to 3/4 of the corneal surface in all the animals. The lesions were associated with slight to severe corneal swelling. Slight to severe conjunctivitis developed in all the animals, iritis developed in four animals and animal had slight discharge. The lesions had healed within 15 days.
Tween 80 (used as control) as supplied, caused slight corneal lesions in two animals, together with slight conjunctivitis in one of the animals. The lesions healed within three days. The remaining four animals were unaffected. - Other effects:
- Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- according to EU CLP (EC1272/2008 and its updates)
- Conclusions:
- Cyclabute was considered not to be irritating to eyes.
- Executive summary:
This study report describes the ability of Cyclabute to induce eye irritation in rabbits. The possible eye irritation potential of cyclabute was tested in one eye of each animal, and application was followed by a 15 day observation period. The study procedures described in this report were based on the Federal Hazardous Substance labelling Act Method (similar to OECD 405).
One eye of each rabbit (6 rabbits in total) was treated with a drop of local anesthetic (amethocaine hydrochloride) prior to application of 0.1 mL Cyclabute. Treatment was followed by a 15 day observation period with typical observation points at 15 minutes, 4 hours, and daily thereafter. 6 Other rabbits were treated with Tween-80 in one eye for control purposes. Corneal, conjunctival and iridial damage was scored to determine eye irritation potential.
Cyclabute, as supplied, caused slight to moderate corneal lesions affecting up to 3/4 of the corneal surface in all the animals. The lesions were associated with slight to severe corneal swelling. Slight to severe conjunctivitis developed in all the animals, iritis developed in four animals and one animal had slight discharge. The lesions had healed within 15 days. The negative control substance Tween 80, as supplied, caused slight corneal lesions in two animals, together with slight conjunctivitis in one of the animals. The lesions healed within three days. The remaining four animals were unaffected. The substance is not an eye irritant.
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