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Diss Factsheets
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EC number: 264-598-7 | CAS number: 64001-15-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- The in vivo skin irritation test is performed before the REACH regulation came into force requesting in vitro studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02-11-1976 - 13-12-1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted similar to OECD Test Guideline No. 404, but not under GLP Standards.
- Justification for type of information:
- Information used to read across to Cyclacet Dihydro.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information is derived from read across.
- Justification for type of information:
- The information for Cyclacet Dihydro is derived from Cyclacet. The information is based on the analogue Cyclacet. The justification is presented in the Endpoint summary and includes also eye irritation. The accompanying file is also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Other effects / acceptance of results:
- In vivo information is available before the Reach Regulation came into force requesting in vitro studies.
- Irritation parameter:
- other: mean irritation ranking
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated score. - Interpretation of results:
- other: not irritating
- Remarks:
- according to the EU CLP Regulation 1272/2008 and its amendments
- Conclusions:
- The substance is not a skin irritant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 10 animals used; different scoring system; observation < 14 days (Reversibility check); positve and negative control substances used.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- EC Number:
- 911-369-0
- Molecular formula:
- C12H16O2
- IUPAC Name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-5-yl acetate and 3a,4,5,6,7,7a-hexahydro-4,7-methanoinden-6-yl acetate
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
Controls:
Positve control: Cyclamen Aldehyde
Negative control: Diethyl Phthalate - Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 4, 24, 48 and 72 hours
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- % coverage: no data
- Type of wrap if used: Patches are prepared by heat-sealing 1" x 1" 24 ply gauze pads on to 1 1/4" x 1 1/4" squares of polythene sheeting which is then attached to 3 1/2" x 1" strips of adhesive tape. Test solutions are applied to a dry patch. The patches are firmly attached to ensure good contact between the skin and test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean
- Time after start of exposure:4 hours
SCORING SYSTEM: The sites are scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from “a” (very slight) to “h” (severe). At the end of the test the reaction grades are converted to corresponding numerical scores which are used to calculate the total irritation score per animal, an overall score per treatment group, a mean irritation score per site, and a mean irritation score per site per day for each treatment group. A mean irritation ranking for each treatment group is also given.
Reaction Grades and Scores of erythema, oedema, cracking and scaling:
a marginal/very slight = 1
b slight = 2
c fairly distinct =3
d quite distinct = 4
e becoming well developed = 6
f well developed = 8
g becoming severe = 10
h severe = 12
STATISTICS:
The Wilcoxon Matched-Pairs Signed Ranks Test, which considers the size and direction of differences between reactions is used to test the significance of differences between pairs of treatment groups.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: mean irritation ranking
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated value, except for the last value: the mean score per site per day. - Other effects:
- no data
Any other information on results incl. tables
Under the conditions of this test Jasmacyclene (crude) produced slight to moderate irritation consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. The test substance was significantly more irritant than the negative control, diethyl phthalate, which produced only a marginal response. The test ingredient was significantly less irritant than the positive control, cyclamen aldehyde, which produced well-developed erythema fairly distinct cracking and slight scaling.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- according to the EU CLP Regulation 1272/2008 and its amendments
- Conclusions:
- In a Rabbit Covered Patch Skin Irritation Test, single 4-hour-exposure of Jasmacyclene (crude), under semi-occlusive conditions, caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. No classification and labelling is required based on these results.
- Executive summary:
The skin irritation/corrosion potential of Cyclacet was investigated in a study similar to OECD Test Guideline 404 (Acute Dermal Irritation / Corrosion). In this Rabbit Covered Patch Skin Irritation Test, single 4 -hour-exposure of Cyclacet under semi-occlusive conditions caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. This does not result in the substance being a skin irritant.
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.
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