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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 14 May 2013 and 12 June 2013.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. The substance is adequately identified, but details on composition are missing. Therefore validation applies with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Council regulation No.440/2008.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2012-04-23&24 / Signed on 2012-07-18.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (6E)-6-(2,4,4-trimethylcyclopentylidene)hexanal
- Cas Number:
- 1429808-42-3
- Molecular formula:
- C14 H24 O
- IUPAC Name:
- (6E)-6-(2,4,4-trimethylcyclopentylidene)hexanal
- Reference substance name:
- (6Z)-6-(2,4,4-trimethylcyclopentylidene)hexanal
- Cas Number:
- 1429808-41-2
- Molecular formula:
- C14 H24 O
- IUPAC Name:
- (6Z)-6-(2,4,4-trimethylcyclopentylidene)hexanal
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless to light yellow translucent liquid
- Storage condition of test material: fridge 6°C±3°C
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Date received: 22 April 2013
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 185 - 220 g
- Housing: housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff (SAFE, A04), ad libitum but food was removed at D-1 and then redistributed 4 hours after the test item administration.
- Water: tap-water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70%
- Air changes: approximately thirteen changes per hour.
- Photoperiod: 12 h light/12 h darkness.
IN-LIFE DATES: from 14 May to 12 June 2013.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.22 mL/kg bw
ADMINISTRATION OF TEST ITEM:
* In the first and second step of the study, 0.33 mL (corresponding to 300 mg, according to the calculated density) of the test item was added to 1.89 mL of olive oil. The preparation was administered under a volume of 2.22 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
* In the third and fourth step of the study, the test item was administered by gavage under a volume of 2.22 mL/kg body weight (corresponding to 2000 mg/kg according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.
VEHICLE
- Concentration in vehicle: 1.89 mL (first and second step, at 300 mg/kb bw)
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min, 1, 3 and 4 hours after test item administration and thereafter once daily for 14 days. Animals were weighed pretest (Day 0) and on Day 2, 7 and 14.
- Necropsy of survivors performed: Yes; Animals were killed on Day 14 and subjected to macroscopic examination. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred during the study.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed during the study.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off may be considered to be higher than 5000 mg/kg body in female rats. Therefore, the substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given oral dose (gavage) of 300 mg/kg body weight and then 6 female Sprague Dawley rats were given the dose of 2000 mg/kg body weight (gavage). Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Oral LD50 Female > 2000 mg/kg bw
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw and the LD50 cut-off may be considered to be higher than 5000 mg/kg body in female rats. Therefore, the substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral 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.