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EC number: 944-530-9 | CAS number: 84929-26-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- purity of test substance; details of acclimation; environmental conditions; evaluation criteria not reported
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the genotoxic, cytotoxic, and antitumor properties of Commiphora molmol using normal and Ehrlich ascites carcinoma cell-bearing Swiss albino mice.
- Author:
- Qureshi S, al-Harbi MM, Ahmed MM, Raza M, Giangreco AB and Shah AH.
- Year:
- 1 993
- Bibliographic source:
- Cancer Chemother Pharmacol. 33(2):130-138.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- composition of test substance; details of acclimation; environmental conditions; evaluation criteria not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- Resinoid of Commiphora myrrha (Burseraceae) obtained from the gum by ethanol extraction
- EC Number:
- 944-530-9
- Cas Number:
- 84929-26-0
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Resinoid of Commiphora myrrha (Burseraceae) obtained from the gum by ethanol extraction
- Test material form:
- solid
- Details on test material:
- - Name: C. Molmol
- Source: collected from the local market in Riyadh, Saudi Arabia
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Samples of oleo gum resin (Commiphora molmol) was collected from a local market in Riyadh, Saudi Arabia.
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Animal Care Center, King Saud University, Saudi Arabia.
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 20-25 g
- Assigned to test groups randomly: Yes; animals were randomly assigned to different control and treatment groups
- Diet: Purina chow diet, ad libitum
- Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Animals were maintained under standard conditions of humidity, temperature, and light (12 h light/12 h dark cycle).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was given orally to animals as a fresh aqueous suspension. - Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 125 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 5 females/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Cyclophosphamide
- Route of administration: Intraperitoneal
- Doses / concentrations: 100 mg/kg bw
- CP was injected 30 h before the animals were killed.
Examinations
- Tissues and cell types examined:
- The polychromatic erythrocytes (PCE/1000 per mouse) were screened for micronuclei, and reduction of the mitotic index was assessed on the basis of the ratio of polychromatic to normochromatic erythrocytes (PCE/NCE ratio).
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The highest dose of oleo gum resin used in the present study (500 mg/kg bw/day) had previously been reported to be pharmacologically active and was found to be effective in a preliminary study on its cytotoxic activity.
TREATMENT AND SAMPLING TIMES:
In each case, animals were killed 30 h after the last treatment. The femurs were used for a micronucleus test
DETAILS OF SLIDE PREPARATION:
The micronucleus test procedure described by Schmid was followed. The femoral cells were collected in fetal calf serum. After centrifugation, the cells were spread on slides and air-dried. Coded slides were fixed in methanol and stained in May-Gruenwald solution followed by Giemsa stain.
METHOD OF ANALYSIS:
The polychromatic erythrocytes (PCE/1000 per mouse) were screened for micronuclei, and reduction of the mitotic index was assessed on the basis of the ratio of polychromatic to normochromatic erythrocytes (PCE/NCE ratio). - Statistics:
- Statistical analysis was performed with Student's t-test.
Results and discussion
Test results
- Key result
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay):Test substance caused no significant difference in the incidence of micronucleated PCE in femoral cells of normal mice as compared with the controls.
- Ratio of PCE/NCE (for Micronucleus assay): There was a statistically significant decrease in the PCE/NCE ratio in the treatment groups, indicating the cytotoxic potential of test substance.
- Positive control: Cyclophosphamide significantly increased the number of micronucleated PCE and decreased the PCE/NCE ratio.
Any other information on results incl. tables
Table 7.6.2/1: Micronucleus test – results
Groups |
Treatment and dose (mg/kg day) |
PCE screened |
Percentage of micronucleated PCE (mean ± SE) |
NCE screened |
PCE/NCE ratio (mean ± SE) |
1 |
Control (Distilled water) |
5996 |
0.43 ± 0.04 |
5690 |
1.10 ± 0.09 |
2 |
Cyclophosphamide 100 |
4472 |
4.20 ± 0.23*** |
6700 |
0.67 ± 0.10** |
Test substance |
|||||
3 |
125 |
5300 |
0.28 ± 0.09 |
6500 |
0.81 ± 0.10* |
4 |
250 |
5000 |
0.30 ± 0.06 |
6600 |
0.76 ± 0.12* |
5 |
500 |
5600 |
0.33 ± 0.02 |
8000 |
0.72 ± 0.08** |
Groups 2, 3, 4, and 5 were statistically compared with group 1. Five mice were used in each group
*P <0.05, **P <0.01, ***P <0.001; Student's t-test
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance did not show any evidence of causing an increase in the induction of micronucleated polychromatic erythrocytes in mice.
- Executive summary:
In an in vivo micronucleus test conducted similarly to OECD 474 guideline, Swiss mice (5 females/dose) were administered with test substance by oral (gavage) at the dose levels of 125, 250 and 500 mg/kg bw/day for 7 days. Vehicle control group was administered with distilled water and positive control groups were given cyclophosphamide (100 mg/kg bw, IP). Animals were sacrificed 30 h after the last treatment and the femurs were used for a micronucleus test. The polychromatic erythrocytes (PCE/1000 per mouse) were screened for micronuclei, and reduction of the mitotic index was assessed on the basis of the ratio of polychromatic to normochromatic erythrocytes (PCE/NCE ratio).
There was a statistically significant decrease in the PCE/NCE ratio in the treatment groups, indicating the cytotoxic potential of test substance. Test substance caused no significant difference in the incidence of micronucleated PCE in femoral cells of normal mice as compared with the controls. Cyclophosphamide significantly increased the number of micronucleated PCE and decreased the PCE/NCE ratio.
Under the test conditions, test substance did not show any evidence of causing an increase in the induction of micronucleated polychromatic erythrocytes in mice.
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