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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 932-349-8 | CAS number: 8006-64-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March-May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- other: Study plan
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- Pin-2(10)-ene
- EC Number:
- 204-872-5
- EC Name:
- Pin-2(10)-ene
- Cas Number:
- 127-91-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- Dipentene
- EC Number:
- 205-341-0
- EC Name:
- Dipentene
- Cas Number:
- 138-86-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexene
- Reference substance name:
- Camphene
- EC Number:
- 201-234-8
- EC Name:
- Camphene
- Cas Number:
- 79-92-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- p-mentha-1,4(8)-diene
- EC Number:
- 209-578-0
- EC Name:
- p-mentha-1,4(8)-diene
- Cas Number:
- 586-62-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexene
- Reference substance name:
- p-cymene
- EC Number:
- 202-796-7
- EC Name:
- p-cymene
- Cas Number:
- 99-87-6
- Molecular formula:
- C10H14
- IUPAC Name:
- 1-isopropyl-4-methylbenzene
- Reference substance name:
- 1,7,7-trimethyltricyclo[2.2.1.02,6]heptane
- EC Number:
- 208-083-7
- EC Name:
- 1,7,7-trimethyltricyclo[2.2.1.02,6]heptane
- Cas Number:
- 508-32-7
- Molecular formula:
- C10H16
- IUPAC Name:
- 1,7,7-trimethyltricyclo[2.2.1.0~2,6~]heptane
- Reference substance name:
- 7,7-dimethyl-2-methylenebicyclo[2.2.1]heptane
- EC Number:
- 610-330-2
- Cas Number:
- 471-84-1
- Molecular formula:
- C10H16
- IUPAC Name:
- 7,7-dimethyl-2-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- p-mentha-1,4-diene
- EC Number:
- 202-794-6
- EC Name:
- p-mentha-1,4-diene
- Cas Number:
- 99-85-4
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexa-1,4-diene
- Reference substance name:
- 7-methyl-3-methyleneocta-1,6-diene
- EC Number:
- 204-622-5
- EC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Cas Number:
- 123-35-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Reference substance name:
- p-mentha-1(7),2-diene
- EC Number:
- 209-081-9
- EC Name:
- p-mentha-1(7),2-diene
- Cas Number:
- 555-10-2
- Molecular formula:
- C10H16
- IUPAC Name:
- 3-isopropyl-6-methylenecyclohexene
- Test material form:
- liquid
- Details on test material:
- Batch No.: FAB-08082017
Name of test material (as cited in study report): gum turpentine oil
Physical state: colourless - slightly yellow liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiration Date: 07 August 2018
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: Approximately 65 days old
- Weight at study initiation: 227 to 254 g
- Housing: After mating and allocation, females will be housed singly to permit collection of food consumption data individually for pregnant females.
Grid bottomed cages will be suspended above absorbent paper which will be changed daily during pairing. Solid bottomed cages will have bedding which will be changed at appropriate intervals. Cages, cage-trays, food hoppers and water bottles will be changed at appropriate intervals.
- Diet (ad libitum): SDS VRF1 Certified pelleted diet
- Water (ad libitum): Potable water from the public supply via polycarbonate bottles with sipper tubes.
- Acclimation period: Five days before commencement of pairing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24ºC
- Humidity (%): 40-70%.
- Air changes : Filtered fresh air which was passed to atmosphere and not recirculated.
- Photoperiod (hrs dark / hrs light):12 hours light : 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Method of preparation: The formulation procedure will be documented in the study data and included in the final report.
- Frequency of preparation: Weekly. If weekly formulation is not supported by the homogeneity and stability data, a more frequent mixing regime will need to be initiated
- Storage of preparation: Refrigerated (nominally 2-8 °C)
VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg bw/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of each formulation prepared for administration in Week 1 and the last week will be analyzed for achieved concentration of the test item.
- Details on mating procedure:
- - Impregnation procedure: Cohoused
- M/F ratio per cage: 1:1
- Proof of pregnancy: Ejected copulation plug / sperm in vaginal smear referred to as Day 0 of pregnancy.
- A colony of stud males is maintained specifically for the purpose of mating; these animals will not be part of the study and are maintained as stock animals - Duration of treatment / exposure:
- 14 days (Days 6-19 p.c.)
- Frequency of treatment:
- Once daily at approximately the same
time each day
- No. of animals per sex per dose:
- 20 mated females/dose
- Control animals:
- yes
- Details on study design:
- Dose levels will be selected in conjunction with the Sponsor based on the results of the preliminary embryo-fetal toxicity study in Sprague Dawley rats (Envigo Study No. YH66TP).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals will be inspected visually at least twice daily for evidence of ill-health or reaction to treatment. Cages and cage-trays will be inspected daily for evidence of animal ill-health amongst the occupant(s).
During the acclimatisation period, observations of the animals and their cages will be recorded at least once per day.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: A detailed physical examination will be performed on each animal on Days 0, 5, 12, 18 and 20 after mating to monitor general health.
Detailed observations will be recorded daily at the following times in relation to dose administration:
At the end of dosing of each group; one to two hours after completion of dosing of all groups; as late as possible in the working day.
BODY WEIGHT: Yes
- Time schedule for examinations: The weight of each adult will be recorded on Days 0, 3 and daily from Days 6 to 20 after mating.
FOOD CONSUMPTION: Yes
- The weight of food supplied to each adult, that remaining and an estimate of any spilled was recorded for the periods Days 0-2, 3-5, 6-9, 10-13, 14-17 and 18-19 inclusive after mating.
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Animals will be killed by carbon dioxide asphyxiation on Day 20 after mating.
- All adult animals will be subject to a detailed necropsy. After a review of the history of each animal, a full macroscopic examination of the tissues will be performed. All external features and orifices will be examined visually. Any abnormality in the appearance or size of any organ and tissue (external and cut surface) will be recorded and the required tissue samples preserved in appropriate fixative. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes; Gravid uterine weight (including cervix and ovaries)
- Number of corpora lutea: Yes
- Number of implantation sites: Yes
- Number of early resorption sites: Yes
- Number of late resorption sites: Yes
- Number of live fetuses: Yes
- Number of dead fetuses: Yes - Fetal examinations:
- Fetuses will be killed by chilling on a cool plate (approximately 0 °C).
Examination of all viable fetuses and placentae: Dissected from the uterus, individually weighed and identified within the litter using a coding system based on their position in the uterus. Examined externally with abnormalities recorded, sampled as appropriate and retained in appropriate fixative. The sex of each fetus will be recorded.
Examination of nominally 50% of fetuses in each litter: Sexed internally and eviscerated.
Fixation: Fetuses eviscerated will be fixed in Industrial Methylated Spirit (IMS). Remaining fetuses will be fixed whole in Bouin’s fluid.
Processing: Bouin’s fixed fetuses will be subject to free-hand serial sectioning for visceral abnormalities. IMS fixed fetuses will be processed and stained with Alizarin Red for skeletal development and abnormalities. - Statistics:
- See "Any other information on materials and methods incl. tables"
- Indices:
- Reproductive assessment
Pre-implantation loss (%) = [(Number of corpora lutea – Number of implantations) / Number of corpora lutea] x 100
Post-implantation loss (%) = [(Number of implantations – Number of live fetuses)/ Number of implantations] x 100
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels (maternal animals)
- Remarks on result:
- other: On-going study
Results (fetuses)
- Changes in postnatal survival:
- not examined
- Description (incidence and severity):
- not relevant for OECD 414
Effect levels (fetuses)
- Remarks on result:
- other: On-going study
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
A preliminary study is currently on-going.
Applicant's summary and conclusion
- Conclusions:
- A preliminary study is currently on-going.
- Executive summary:
In a prenatal developmental toxicity study performed according to OECD Guideline 414 and in compliance with GLP, gum turpentine oil will be administered by oral (gavage) to groups of mated female Crl:CD(SD) rats (20/dose) from Days 6 to 19 after mating at dose levels determined according to the results of the on-going preliminary study.
A similarly constituted Control group will receive the vehicle, corn oil, at the same dose volume. Clinical observations, body weight and food consumption will be recorded. Adult females will be examined macroscopically at necropsy on Day 20 after mating and all fetuses will be examined macroscopically at necropsy and subsequently by detailed internal visceral examination or skeletal examination.
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.