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EC number: 201-291-9 | CAS number: 80-56-8
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- 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
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- Toxicological Summary
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- Exposure related observations in humans
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- Additional toxicological data

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2005
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted similarly to OECD Guideline 474 with deviations: no data on test material purity; age, body weight, housing and exposure conditions of animals; duration of exposure/day; positive/negative controls; polychromatic erythrocytes not scored
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:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- no data on test material purity; age, body weight, housing and exposure conditions of animals; duration of exposure/day; positive/negative controls; polychromatic erythrocytes not scored
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
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
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- None
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- - Vehicle(s)/solvent(s) used: Air
- Details on exposure:
- None
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 50, 100, 200 or 400 ppm
Basis:
no data
- No. of animals per sex per dose:
- Five
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Peripheral blood samples
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Doses extend up to the maximum tolerated dose
TREATMENT AND SAMPLING TIMES: Sample collection time: 24 hours
DETAILS OF SLIDE PREPARATION: Slides were air-dried, fixed and stained with a fluorescent DNA-specific stain (acridine orange).
METHOD OF ANALYSIS: Slides were scanned to determine the frequency of micronuclei in 2000 normochromatic erythrocytes (NCEs) per animal. In addition, the percentage of normochromatic erythrocytes (%NCEs) and micronucleus cells in a population of 1000 erythrocytes was determined. - Evaluation criteria:
- No data
- Statistics:
- Significance of micronucleated NCEs/1000 NCEs tested by trend test (significant at P ≤ 0.025), followed by Pairwise comparison with the vehicle controls (significant at P ≤ 0.008)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Frequency of micronuclei in peripheral blood erythrocytes: See table 1 and 2
Any other information on results incl. tables
Table 1: Frequency of micronuclei in peripheral blood erythrocytes of male mice following administration of α-pinene
Start Date |
Sample Collection Time |
Sex |
Dosing Regimen |
|||||
07/25/2005 |
24 Hours |
Male |
INHAL x 5, 13 Weeks |
|||||
|
Dose (ppm)
|
Animal Number
|
Normochromatic Erythrocytes |
|||||
Trend P = 0.742 |
||||||||
No. Examined |
Total MN Cells |
Percent NCE |
MN Cells |
|||||
per 1000 |
||||||||
Vehicle Control |
Air |
0 |
XM0001 |
2000 |
3 |
98.7 |
1.5 |
|
|
0 |
XM0002 |
2000 |
5 |
97.9 |
2.5 |
||
|
0 |
XM0003 |
2000 |
1 |
97.6 |
0.5 |
||
|
0 |
XM0004 |
2000 |
3 |
96.5 |
1.5 |
||
|
0 |
XM0005 |
2000 |
4 |
96.8 |
2.0 |
||
Average ± SEM |
|
97.50 ± 0.39 |
1.60 ± 0.33 |
|||||
|
||||||||
Test Chemical |
|
25 |
AM0201 |
2000 |
3 |
97.7 |
1.5 |
|
|
25 |
AM0202 |
2000 |
5 |
97.0 |
2.5 |
||
|
25 |
AM0203 |
2000 |
3 |
98.1 |
1.5 |
||
|
25 |
AM0204 |
2000 |
2 |
97.6 |
1.0 |
||
|
25 |
AM0205 |
2000 |
5 |
97.9 |
2.5 |
||
Average ± SEM |
|
97.66 ± 0.19 |
1.80 ± 0.30 |
|||||
Pairwise P |
|
0.366 |
||||||
|
||||||||
Test Chemical |
|
50 |
BM0401 |
2000 |
3 |
98.5 |
1.5 |
|
|
50 |
BM0402 |
2000 |
3 |
97.1 |
1.5 |
||
|
50 |
BM0403 |
2000 |
2 |
98.1 |
1.0 |
||
|
50 |
BM0404 |
2000 |
8 |
97.3 |
4.0 |
||
|
50 |
BM0405 |
2000 |
3 |
98.0 |
1.5 |
||
Average ± SEM |
|
97.80 ± 0.26 |
1.90 ± 0.53 |
|||||
Pairwise P |
|
0.306 |
||||||
|
||||||||
Test Chemical |
|
100 |
CM0601 |
2000 |
4 |
96.8 |
2.0 |
|
|
100 |
CM0602 |
2000 |
5 |
96.9 |
2.5 |
||
|
100 |
CM0603 |
2000 |
2 |
96.4 |
1.0 |
||
|
100 |
CM0604 |
2000 |
3 |
98.2 |
1.5 |
||
|
100 |
CM0605 |
2000 |
7 |
97.3 |
3.5 |
||
Average ± SEM |
|
97.12 ± 0.31 |
2.10 ± 0.43 |
|||||
Pairwise P |
|
0.205 |
||||||
|
||||||||
Test Chemical |
|
200 |
DM0801 |
2000 |
5 |
97.1 |
2.5 |
|
|
200 |
DM0802 |
2000 |
4 |
96.7 |
2.0 |
||
|
200 |
DM0803 |
2000 |
2 |
97.8 |
1.0 |
||
|
200 |
DM0804 |
2000 |
5 |
97.5 |
2.5 |
||
|
200 |
DM0805 |
2000 |
3 |
97.2 |
1.5 |
||
Average ± SEM |
|
97.26 ± 0.19 |
1.90 ± 0.29 |
|||||
Pairwise P |
|
0.306 |
||||||
|
||||||||
Test Chemical |
|
400 |
EM1001 |
2000 |
3 |
97.3 |
1.5 |
|
|
400 |
EM1002 |
2000 |
1 |
96.7 |
0.5 |
||
|
400 |
EM1003 |
2000 |
5 |
96.8 |
2.5 |
||
|
400 |
EM1004 |
2000 |
1 |
97.4 |
0.5 |
||
|
400 |
EM1005 |
2000 |
4 |
96.3 |
2.0 |
||
Average ± SEM |
|
96.90 ± 0.20 |
1.40 ± 0.40 |
|||||
Pairwise P |
|
0.643 |
Table 2: Frequency of micronuclei in peripheral blood erythrocytes of female mice following administration of α-pinene
Start Date |
Sample Collection Time |
Sex |
Dosing Regimen |
|||||
07/26/2005 |
24 Hours |
Female |
INHAL x 5, 13 Weeks |
|||||
|
Dose (ppm)
|
Animal Number
|
Normochromatic Erythrocytes |
|||||
Trend P = 0.899 |
||||||||
No. Examined |
Total MN Cells |
Percent NCE |
MN Cells |
|||||
per 1000 |
||||||||
Vehicle Control |
Air |
0 |
XF0101 |
2000 |
3 |
97.4 |
1.5 |
|
|
0 |
XF0102 |
2000 |
3 |
98.0 |
1.5 |
||
|
0 |
XF0103 |
2000 |
2 |
97.0 |
1.0 |
||
|
0 |
XF0104 |
2000 |
2 |
98.0 |
1.0 |
||
|
0 |
XF0105 |
2000 |
4 |
97.6 |
2.0 |
||
Average ± SEM |
|
97.60 ± 0.19 |
1.40 ± 0.19 |
|||||
|
||||||||
Test Chemical |
|
25 |
AF0301 |
2000 |
3 |
98.0 |
1.5 |
|
|
25 |
AF0302 |
2000 |
7 |
97.0 |
3.5 |
||
|
25 |
AF0303 |
2000 |
5 |
97.9 |
2.5 |
||
|
25 |
AF0304 |
2000 |
2 |
97.7 |
1.0 |
||
|
25 |
AF0305 |
2000 |
4 |
98.6 |
2.0 |
||
Average ± SEM |
|
97.84 ± 0.26 |
2.10 ± 0.43 |
|||||
Pairwise P |
|
0.118 |
||||||
|
||||||||
Test Chemical |
|
50 |
BF0501 |
2000 |
5 |
98.3 |
2.5 |
|
|
50 |
BF0502 |
2000 |
2 |
98.2 |
1.0 |
||
|
50 |
BF0503 |
2000 |
3 |
97.9 |
1.5 |
||
|
50 |
BF0504 |
2000 |
4 |
97.6 |
2.0 |
||
|
50 |
BF0505 |
2000 |
4 |
97.2 |
2.0 |
||
Average ± SEM |
|
97.84 ± 0.20 |
1.80 ± 0.25 |
|||||
Pairwise P |
|
0.240 |
||||||
|
||||||||
Test Chemical |
|
100 |
CF0701 |
2000 |
4 |
97.9 |
2.0 |
|
|
100 |
CF0702 |
2000 |
4 |
97.7 |
2.0 |
||
|
100 |
CF0703 |
2000 |
0 |
97.2 |
0.0 |
||
|
100 |
CF0704 |
2000 |
4 |
97.6 |
2.0 |
||
|
100 |
CF0705 |
2000 |
5 |
95.9 |
2.5 |
||
Average ± SEM |
|
97.26 ± 0.36 |
1.70 ± 0.44 |
|||||
Pairwise P |
|
0.295 |
||||||
|
||||||||
Test Chemical |
|
200 |
DF0901 |
2000 |
2 |
98.8 |
1.0 |
|
|
200 |
DF0902 |
2000 |
5 |
97.7 |
2.5 |
||
|
200 |
DF0903 |
2000 |
4 |
97.6 |
2.0 |
||
|
200 |
DF0904 |
2000 |
2 |
98.4 |
1.0 |
||
|
200 |
DF0905 |
2000 |
4 |
97.2 |
2.0 |
||
Average ± SEM |
|
97.94 ± 0.29 |
1.70 ± 0.30 |
|||||
Pairwise P |
|
0.295 |
||||||
|
||||||||
Test Chemical |
|
400 |
EF1101 |
2000 |
1 |
98.0 |
0.5 |
|
|
400 |
EF1102 |
2000 |
2 |
97.7 |
1.0 |
||
|
400 |
EF1103 |
2000 |
2 |
97.9 |
1.0 |
||
|
400 |
EF1104 |
2000 |
3 |
97.9 |
1.5 |
||
|
400 |
EF1105 |
2000 |
3 |
97.7 |
1.5 |
||
Average ± SEM |
|
97.84 ± 0.06 |
1.10 ± 0.19 |
|||||
Pairwise P |
|
0.726 |
Applicant's summary and conclusion
- Conclusions:
- alpha-Pinene was not mutagenic in the mouse peripheral blood micronucleus test.
- Executive summary:
In a peripheral blood micronucleus test conducted similarly to OECD Guideline 474, α-pinene was administered through inhalation to groups of B6C3F1 mice (5/sex/dose) at dose levels of 0, 25, 50, 100, 200 or 400 ppm; 5 days/week for 13 weeks. Peripheral blood samples were obtained 24 hours after the last dosing. Smear slides were air-dried, fixed, stained with fluorescent DNA-specific stain (acridine orange) and scanned to determine the frequency of micronuclei in 2000 normochromatic erythrocytes (NCEs) per animal. In addition, the percentage of normochromatic erythrocytes (%NCEs) and micronucleus cells in a population of 1000 erythrocytes was determined.
No increase in the frequency of micronucleated NCEs/1000 NCEs and %NCEs were observed in peripheral blood samples in male or female B6C3F1 mice administered alpha-pinene.
Therefore, alpha-pinene was not mutagenic in the mouse peripheral blood micronucleus test.
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