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EC number: 281-679-2 | CAS number: 84012-35-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Pinus sylvestris, Pinaceae.
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:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Read across from structural analogue
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read across from structural analogue
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- reference to other study
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Based on the read-across approach, the target substance did not induce micronuclei in mice.
- Executive summary:
In an in vivo micronucleus test, ten male mice were injected intraperitoneally with Pine needle extract at the dose level of 2000 mg/kg bw and animals were sacrificed 30 h after the test item administration. Negative control (distilled water) and positive controls (cyclophosphamide at 30 mg/kg) were also included in the study. Antimutagenic effect of PNE was also studied with following dose levels at 10 males/group: (PNE + CP): 500 mg/kg bw + 30 mg/kg bw; 1000 mg/kg bw + 30 mg/kg bw; 2000 mg/kg bw + 30 mg/kg bw; 4000 mg/kg bw + 30 mg/kg bw.
Test material did not induce micronucleated PCE when compared with negative control. PNE could decrease the micronucleus frequency (MNF) compared with the cyclophosphamide (positive group) and the PNE + CP groups. Results showed that PNE could decrease the micronucleus induced by CP, and micronucleus frequency decreased markedly at the dose of 2000 mg/kg bw PNE (p < 0.01) demonstrating the antimutagenic effect. Positive control induced a statistically significant increase in micronucleated polychromatic erythrocytes indicating the validity of the study.
Based on the read-across approach, the target substance did not induce micronuclei in mice.
Table 7.6.2/2: In vivo micronucleus test results
Group |
Concentration |
MNF (%) |
PCE (%)
|
|
CP (mg/kg bw) |
PNE (mg/kg bw) |
|||
Distilled water |
|
|
2.18 ± 0.58 |
52.90 ± 4.71 |
CP |
30 |
- |
36.68 ± 1.56* |
40.74 ± 4.42* |
PNE |
- |
2000 |
2.38 ± 1.18 |
53.95 ± 4.50 |
PNE + CP |
30 |
500 |
27.31 ± 1.29* |
51.13 ± 4.21* |
PNE + CP |
30 |
1000 |
18.40 ± 2.73* |
47.58 ± 3.25*** |
PNE + CP |
30 |
2000 |
8.88 ± 1.38* |
42.50 ± 4.32*** |
PNE + CP |
30 |
4000 |
10.53 ± 2.42* |
40.40 ± 3.96*** |
CP: Cyclophosphamide; PNE: Pine needle extract
* p < 0.01, compared to distilled water control; * * p < 0.01, * * * p < 0.05, compared to CP groups.
There was a significant negative correlation (r = -0.9782, p < 0.05) between PNE dose and MNF in the PNE-treated groups in comparison to the CP positive group up to 2000 mg/kg bw of PNE. However, when the dose of PNE reached 4000 mg/kg bw, it exhibited some increase of MNF compared with the 2000 mg/kg bw group. This suggested that PNE inhibited the MNF in certain concentration ranges.
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
- Principles of method if other than guideline:
- In an in vivo micronucleus test, mice injected intraperitoneally with Pine needle extract and animals sacrificed for examination of micronucleated polychromatic erythrocytes.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 90082-72-7
- Cas Number:
- 90082-72-7
- IUPAC Name:
- 90082-72-7
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Pine needle extract (ointment); which is mainly composed of steroidal saponins, triterpenoidal saponins, terpenes and aromatic acids.
- Source: Jiangsu Institute of Cancer Research, China.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Center of Nanjing University, Nanjing, China.
- Weight at study initiation: 18-22 g (at receipt)
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- 30 h after test item administration
- Frequency of treatment:
- Single
- Post exposure period:
- None
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- yes
- Positive control(s):
- - Positive control: Cyclophosphamide: 30 mg/kg bw
- Route of administration: Intraperitoneal
Examinations
- Tissues and cell types examined:
- Micronucleus frequency in polychromatic erythrocytes (PCE) was determined by the routine method of Schmid (1973). 1000 PCEs in each animal were examined for micronucleus.
- Evaluation criteria:
- No data
- Statistics:
- The data were statistically evaluated with the t-test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 7.6.2/2: In vivo micronucleus test results
Group |
Concentration |
MNF (%) |
PCE (%)
|
|
CP (mg/kg bw) |
PNE (mg/kg bw) |
|||
Distilled water |
|
|
2.18 ± 0.58 |
52.90 ± 4.71 |
CP |
30 |
- |
36.68 ± 1.56* |
40.74 ± 4.42* |
PNE |
- |
2000 |
2.38 ± 1.18 |
53.95 ± 4.50 |
PNE + CP |
30 |
500 |
27.31 ± 1.29* |
51.13 ± 4.21* |
PNE + CP |
30 |
1000 |
18.40 ± 2.73* |
47.58 ± 3.25*** |
PNE + CP |
30 |
2000 |
8.88 ± 1.38* |
42.50 ± 4.32*** |
PNE + CP |
30 |
4000 |
10.53 ± 2.42* |
40.40 ± 3.96*** |
CP: Cyclophosphamide; PNE: Pine needle extract
* p < 0.01, compared to distilled water control; * * p < 0.01, * * * p < 0.05, compared to CP groups.
There was a significant negative correlation (r = -0.9782, p < 0.05) between PNE dose and MNF in the PNE-treated groups in comparison to the CP positive group up to 2000 mg/kg bw of PNE. However, when the dose of PNE reached 4000 mg/kg bw, it exhibited some increase of MNF compared with the 2000 mg/kg bw group. This suggested that PNE inhibited the MNF in certain concentration ranges.
Applicant's summary and conclusion
- Conclusions:
Under the test conditions, Pine needle extract did not induce micronuclei in mice.- Executive summary:
In an in vivo micronucleus test, ten male mice were injected intraperitoneally with Pine needle extract at the dose level of 2000 mg/kg bw and animals were sacrificed 30 h after the test item administration. Negative control (distilled water) and positive controls (cyclophosphamide at 30 mg/kg) were also included in the study. Antimutagenic effect of PNE was also studied with following dose levels at 10 males/group: (PNE + CP): 500 mg/kg bw + 30 mg/kg bw; 1000 mg/kg bw + 30 mg/kg bw; 2000 mg/kg bw + 30 mg/kg bw; 4000 mg/kg bw + 30 mg/kg bw.
Test material did not induce micronucleated PCE when compared with negative control. PNE could decrease the micronucleus frequency (MNF) compared with the cyclophosphamide (positive group) and the PNE + CP groups. Results showed that PNE could decrease the micronucleus induced by CP, and micronucleus frequency decreased markedly at the dose of 2000 mg/kg bw PNE (p < 0.01) demonstrating the antimutagenic effect. Positive control induced a statistically significant increase in micronucleated polychromatic erythrocytes indicating the validity of the study.
Under the test conditions, Pine needle extract did not induce micronuclei in mice.
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