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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-309-3 | CAS number: 68956-56-9
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 weeks in 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Recent study conducted by NTP similarly to OECD guideline 413 with deviations: food consumption, hematology, ophthalmological examination, some organ weights were not recorded.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: data available on NTP website
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- food consumption, hematology, ophthalmological examination, some organ weights were not recorded
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- 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
- Details on test material:
- - Purity ≥ 97%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- After a 10- to 14-day quarantine period, animals are assigned at random to treatment groups.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Remarks on MMAD:
- MMAD / GSD: No data
- Details on inhalation exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 14 weeks; 6 hours per day
- Frequency of treatment:
- Five times per week, weekdays only
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
50 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
200 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
400 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- No
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes for moribundity and death
- Time schedule: twice daily, at least 6 hours apart (before 10:00 AM and after 2:00 PM)
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: on Day 1 of the test, after 7 days and at weekly intervals thereafter
FOOD CONSUMPTION: No
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- Kaplan-Meier used for probability of survival. Statistical analyses used for possible dose-related effect on survival was Cox (Cox D.R. (1972) Regression models and life tables. J.R. Stat. Soc. B34: 187-220.) for testing two groups for equality; and Tarone’s (Tarone R.E. (1975) Tests for trend in life table analysis. Biometrika 62; 679-682) life table test for a dose-related trend.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- MORTALITY
All mice survived until the terminal sacrifice.
CLINICAL EXAMINATION
There were no treatment-related clinical signs.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was comparable for all test animals when compared to controls.
CLINICAL CHEMISTRY
No data available.
ORGAN WEIGHTS
Absolute liver weights were increased for both sexes at the 400 ppm and relative and absolute liver weights were increased for both sexes at 200 ppm and 400 ppm. The 400 ppm male group showed decreased absolute and relative thymus weight. No gross or microscopic lesions were associated with these organ weight findings.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histopathological examination of male and female mice exposed to atmospheres of ≥100 ppm of α-pinene revealed evidence of hyperplasia of the transitional epithelium of the urinary bladder. However, there was no evidence of histopathological changes to the clitoris, ovaries, uterus, epididymis, preputial gland, seminal vesicles, and testes any of the control or test groups of animals.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Presence of transitional cell hyperplasia of the urinary bladder at 100 ppm.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1 - Histopathological effects - Urinary bladder - Males
Dose Group | Urinary bladder - Transitional epithelium - Hyperplasia Number of animals |
|||
Absent | Minimal | Mild | Moderate | |
Vehicle Control | 10 | 0 | 0 | 0 |
25 ppm | 10 | 0 | 0 | 0 |
50 ppm | 10 | 0 | 0 | 0 |
100 ppm | 3 | 6 | 1 | 0 |
200 ppm | 0 | 0 | 10 | 0 |
400 ppm | 0 | 0 | 5 | 5 |
Table 2 - Histopathological effects - Urinary bladder - Females
Dose Group | Urinary bladder - Transitional epithelium - Hyperplasia Number of animals |
|||
Absent | Minimal | Mild | Moderate | |
Vehicle Control | 10 | 0 | 0 | 0 |
25 ppm | 10 | 0 | 0 | 0 |
50 ppm | 10 | 0 | 0 | 0 |
100 ppm | 4 | 6 | 0 | 0 |
200 ppm | 0 | 4 | 6 | 0 |
400 ppm | 0 | 0 | 8 | 2 |
Applicant's summary and conclusion
- Conclusions:
- The NOAEL in male and female rats is 50 ppm based on minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder in animals treated at 100 to 400 ppm.
- Executive summary:
In a 90-day inhalation study conducted by NTP similarly to OECD guideline 413, groups of 10 animals per dose and per sex were administered for 6 hours per day, 5 weekdays per week at 0, 25, 50, 100, 200 and 400 ppm for a total of 14 weeks. The animals were observed twice per day and weighed once per week. A complete histopathologic evaluation including treatment-related gross lesions was performed on all animals including early death animals. Treatment-related lesions (target organs) were identified and these organs and gross lesions were examined to a no-effect level.
Similar effects were observed in male and female mice from the same dose level (100 ppm): minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder.
The NOAEL in male and female rats is 50 ppm based on minimal to moderate hyperplasia observed in the transitional epithelium of the urinary bladder in animals treated at 100 to 400 ppm.
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.