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EC number: 232-077-3 | CAS number: 7785-26-4
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD 414 Guideline without deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
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:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (-)-pin-2(3)-ene
- EC Number:
- 232-077-3
- EC Name:
- (-)-pin-2(3)-ene
- Cas Number:
- 7785-26-4
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- (+)-pin-2(3)-ene
- EC Number:
- 232-087-8
- EC Name:
- (+)-pin-2(3)-ene
- Cas Number:
- 7785-70-8
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-337-8
- EC Name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-04-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,4R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-336-2
- EC Name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-03-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,4S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (-)-pin-2(10)-ene
- EC Number:
- 242-060-2
- EC Name:
- (-)-pin-2(10)-ene
- Cas Number:
- 18172-67-3
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,5S)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- 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:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Cas Number:
- 19902-08-0
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Test material form:
- liquid
- Details on test material:
- Batch No. : 1000107238
Purity : 89%
Name of test material (as cited in study report): (-)-alpha-pinene
Physical state: colourless liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry Date: 30 November 2021
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
- Specific details on test material used for the study:
- Alpha-pinene multiconstituent or (-)-alpha-pinene, depending on the results of the on-going preliminary study on (-)-alpha-pinene, designed to check if both substances have similar toxicity.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Females were treated from Day 6 to Day 19 (inclusive) after mating
- 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, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were inspected visually at least twice daily for evidence of ill-health or reaction to treatment. Cages were inspected daily for evidence of animal ill-health amongst the occupant(s).
During the acclimatization period, observations of the animals and their cages were recorded at least once per day.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed observations were recorded daily at the following times in relation to dose administration: At the end of dosing each group; One to two hours after completion of dosing all groups; As late as possible in the working day
A detailed physical examination was performed on each animal on Days 0, 5, 12, 18 and 20 after mating to monitor general health.
BODY WEIGHT: Yes
- Time schedule for examinations: The weight of each adult was recorded on Days 0, 3 and daily from Day 6 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 after mating inclusive.
POST-MORTEM EXAMINATIONS: Yes
- Animals were killed on Day 20 after mating by Carbon dioxide asphyxiation
- Necropsy: All adult animals were subject to a detailed necropsy. After a review of the history of each animal, a full macroscopic examination of the tissues was performed. All external features and orifices were examined visually. Any abnormality in the appearance or size of any organ and tissue (external and cut surface) was 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 (including cervix and ovaries): Yes
- Number of corpora lutea: Yes
- Number of implantation sites: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Number of Fetuses (live and dead): Yes - Fetal examinations:
- Method of kill for fetuses: 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. The sex of each fetus was recorded.
Examination of nominally 50% of fetuses in each litter: Sexed internally and eviscerated.
Fixation: Fetuses eviscerated were fixed in Industrial Methylated Spirit (IMS). Remaining fetuses were fixed whole in Bouin’s fluid.
Processing: Bouin’s fixed fetuses were subject to free-hand serial sectioning.
IMS fixed fetuses were processed and stained with Alizarin Red.
Fetal Pathology Examination
Bouin’s fixed fetuses: Serial sections were examined for visceral abnormalities.
Alizarin Red stained fetuses: Assessed for skeletal development and abnormalities. - Statistics:
- See " Any other information on materials and methods incl. tables"
- Indices:
- 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)
- Description (incidence and severity):
- To be completed
- Description (incidence):
- To be completed
- Description (incidence and severity):
- To be completed
- Description (incidence and severity):
- To be completed
- 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:
- 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
- Description (incidence and severity):
- To be completed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Based on:
- test mat.
- Remarks on result:
- other: On-going study
Maternal abnormalities
- Description (incidence and severity):
- On-going study
Results (fetuses)
- Description (incidence and severity):
- On-going
- Description (incidence and severity):
- On-going
- Description (incidence and severity):
- On-going
- Description (incidence and severity):
- On-going
- Changes in postnatal survival:
- not examined
- Description (incidence and severity):
- On-going
- Description (incidence and severity):
- On-going
- Description (incidence and severity):
- On-going
Effect levels (fetuses)
- Remarks on result:
- other: On-going
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- On-going study
- Executive summary:
On-going study
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