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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-486-7 | CAS number: 56973-85-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- August 27 to September 10, 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only 3 animals/sex used, diluted substance (50%), Occlusive patch instead of semi-occlusive. The study was not considered sufficient in its own for acute dermal toxicity endpoint and was therefore used in a weight of evidence assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From August 27 to September 10, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (age at study initiation and some environmental conditions of animal room not reported)
- Principles of method if other than guideline:
- 5 g/kg bw of the experimental material was administered into the stomach of ten rats by means of a syringe and dosing needle.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Sherman-Wistar albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: the rats were deprived of food but not water for 24 hours prior to dosing.
- Housing: not reported
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS: not reported
IN-LIFE DATES: not reported - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: not applicable
MAXIMUM DOSE VOLUME APPLIED: not specified - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for observations; once before dosing and once after the observation period for weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 50% test item
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 100% test item
- Mortality:
- None
- Clinical signs:
- other: - No untoward symptoms were observed during the first 4-6 hours. - After 18 hours the animals were slightly depressed, ruffled and dirty. They appeared recovered and normal within 24-36 hours.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 Combined (100% test item) > 2500 mg/kg bw. Not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
- Executive summary:
In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, a group of Sherman-Wistar strain rats (5/sex) were administered a single oral dose of diluted test material (50%) at 5000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No untoward symptoms were observed during the first 4-6 hours. After 18 hours the animals were slightly depressed, ruffled and dirty. They appeared recovered and normal within 24-36 hours. No abnormalities were noted at autopsy.
Oral LD50 Combined (50% test item) > 5000 mg/kg bw
Oral LD50 Combined (100% test item) > 2500 mg/kg bw
Under the test conditions, the test material is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Table 7.2.1/1 Observations
dosage Level g/kg |
Number of Animals Dosed |
Mortalities Days |
Total Dead 14 days |
Total Survived 14 days |
Avg. Initial Weight g |
Avg. Final Weight g |
|||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||||||
5.0 | 5 males | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 240 | 275 |
5.0 | 5 females | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 225 | 250 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- abraded skin, occlusive dressing and 3 animals/sex used; test material details not given; no details on source, strain, age, housing of animals and environmental conditions of animal room; LD50 calculation method not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
- EC Number:
- 260-486-7
- EC Name:
- 1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one
- Cas Number:
- 56973-85-4
- Molecular formula:
- C13H20O
- IUPAC Name:
- 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No data
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- PRETREATMENT
All animals had their backs clipped free of hair 24 h prior to testing. All of the animals had their backs abraded prior to dosing.
TEST SITE
- Area of exposure: Test substance was applied to back of each animal.
- Type of wrap if used: Treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data, any excess material was removed.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; gross necropsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 days observation period. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 50% test item
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 100% test item
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- This study cannot be used for classification since the test substance was not tested up to limit doses which are relevant for classification according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
The study was not considered sufficient in its own for acute dermal toxicity endpoint. - Executive summary:
In an acute dermal toxicity study (limit test) performed similarly to the OECD Guideline No. 402, the abraded skin of albino rabbits (3/sex) was occlusively exposed to diluted test substance (50%) for 24 h at dose of 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality or clinical signs were observed. Surviving animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy.
Dermal LD50 Combined (50% test item) > 2000 mg/kg bw . Thus, Dermal LD50 Combined (100% test item) > 1000 mg/kg bw
This study cannot be used for classification since the test substance was not tested up to limit doses which are relevant for classification according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
The study was not considered sufficient in its own for acute dermal toxicity endpoint.
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.