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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-409-2 | CAS number: 1329-99-3
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore it is considered relevant, reliable and adequate for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
- EC Number:
- 939-409-2
- Cas Number:
- 1329-99-3
- Molecular formula:
- C10H16
- IUPAC Name:
- Reaction mass of 1-Methyl-4-(1-methylethenyl)cyclohexene and 1-Methyl-4-(1-methylethylidene)-cyclohexene and 1-methyl-4-(propan-2-yl)cyclohexa-1,3-diene
- Reference substance name:
- Isopropylmethylcyclohexane, tetradehydro derivative
- EC Number:
- 215-532-0
- EC Name:
- Isopropylmethylcyclohexane, tetradehydro derivative
- Cas Number:
- 1329-99-3
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Depanol I; isopropylmethylcyclohexane, tetrahydro derivative; p-menthadiene;
- Substance type: Organic multi constituent
- Physical state: Liquid, colourless, characteristic odour
- Analytical purity: Terpene hydrocarbons: 98.9% (w/w); p- Menthadienes: 96.3%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 2011-07-06
- Lot/batch No.: DEFM102174
- Expiration date of the lot/batch: 2013-06-25
- Stability under test conditions: Stability of the test item in the vehicle was established at 1.0 and 200 mg/mL concentration levels under Advinus study no.G8350.
- Storage condition of test material: Ambient (+18 to +36°C)
- Other: Density: 0.85 – 0.87 g/cm3; Water solubility: <0.5 g/L
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar – HsdCpb: WU
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at study initiation: 9 to 10 weeks at treatment
- Weight at study initiation: 185.40 – 200.17 g
- Fasting period before study: Yes, 16-18 hours; water was not withheld. Food was offered 3-4 hours after dosing.
- Housing: Individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 175 mm), with stainless steel top grill having facilities for pelletted food and drinking water. Bedding: steam sterilized clean paddy husk was used and changed along with the cage twice a week.
- Diet (e.g. ad libitum): Teklad Certified (2014C) Global 14% Protein Rodent Maintenance Diet - Pellet (Certified) manufactured by Harlan Laboratories B.V. Maasheseweg 87c PO Box 553, 5800, AN Venray, The Netherland; ad libitum.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, in polycarbonate bottles with stainless steel sipper tubes; ad libitum.
- Acclimation period: From 5 to 7 days under laboratory condition after physical examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 58-67%
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: August 9, 2012 To: August 30, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: A quantity of 1.0 g of the test item was mixed with Milli-Q water and the volume made up to 5 mL. The test item was not miscible.
Hence a quantity of 1 g of test item was mixed with corn oil and the volume was made up to 5 mL to get the test item concentration of 200 mg/mL suspension. The test item formed a visibly homogenous suspension. Hence, corn oil was used as the vehicle to prepare the test item suspension.
- Lot/batch no. (if required): MKBG9425V
DOSAGE PREPARATION (if unusual): The test item suspension was prepared on each day of the test item administration. A quantity of 4.0 g of the test item was mixed by adding small quantity of the selected vehicle (corn oil) and the volume made up to 20 mL to get the test item concentration of 200 mg/mL suspension. Homogeneity of the test item in the vehicle was maintained by mixing, using glass rod, prior to treatment. Preparation was made prior (within 1 hour) to dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As per the Material Safety Data Sheet provided by the Sponsor, the Acute Oral toxicity (mg/kg) in mouse is >2000 mg/kg body weight, hence the test was started as per Annex 2d of the OECD 423. The starting dose was 2000 mg/kg body weight with 3 animals /step. - Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 3 females per treatment step
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: 5x on test day 1 and 1x daily during days 2-15 post administration; Weighing: on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: as per LD50 cut-off value
- Mortality:
- No pre-terminal deaths.
- Clinical signs:
- other: No clinical signs.
- Gross pathology:
- No abnormality was detected at necropsy in control and treatment groups.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Depanol I has an oral LD50 of >2000 mg/kg body weight and does not have to be classified as per CLP Regulation.
- Executive summary:
The acute oral toxicity study with Depanol I in Wistar rats was tested according to the acute toxic class method. The test item suspended in corn oil was administered as oral gavage to overnight fasted (16 – 18 hours) 3 female rats at the dose of 2000 mg/kg body weight. Vehicle control group animals were administered corn oil. There were no toxic signs and pre-terminal deaths in treatment and control groups. Three additional female rats were tested at the same dose of 2000 mg/kg body weight. There were no toxic signs and pre-terminal deaths in treated and control groups. All animals of both groups gained body weight during 14 days observation period.
The rats of treatment and control groups were subjected to necropsy at termination and there were no abnormalities detected.
Based on the results of the present study, the test item, Depanol I has an oral LD50 of >2000 mg/kg body weight and does not have to be classified as per CLP Regulation.
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.