Registration Dossier
Registration Dossier
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: 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.
- 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

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.
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.
