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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- study conducted similarly to OECD Guideline 401 but with a limited observation period (24 hours only)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- 15 adult rats of both sexes were equally divided into five groups. The first group was used as control (untreated). The second and third groups were given 50 and 100 mg/kg body weight per day of C. molmol, respectively. Doses were given for up to 14 successful days.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- "Wister albino"
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: 3-4 months
- Weight at study initiation: 150-250 g, The mean weight of rats have been estimated from 10 randomly selected rats and was found to be 198.0 g
- Fasting period before study: not reported
- Housing: Rats were divided into five individuals for each group and allocated randomly in separate clean and well ventilated cages.
- Diet : standard pellet diet purchased from ARASCObCompany, KSA.
- Water : The drinking water for treated animals mixed with the required doses of test substance, ad labium
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C.
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark cycle
IN-LIFE DATES: no reported - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Depending on the fact that the mean water consumption of rats is 25 ml/day, the required doses have been calculated according to the followings:
Given dose = [ Required dose (mg) × Mean weight of rats (g) ] / 1000 (g)
Accordingly, the amount of plant powders that should be suspended in rat's drinking water (per liter) has been calculated as the following equation:
Amount = [ Dose × 1000 ml ] / 25 ml - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 successful days
- Frequency of treatment:
- Exposure via drinking water
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 animals / group (male and female)
- Control animals:
- yes
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: once pre-treatment and once thereafter at termination
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Immediately after dissection
- Anaesthetic used for blood collection: No. Animals were euthanized with diethyl ether before collecting blood
- Animals fasted: Not specified
- How many animals: All (5/group)
- Parameters: white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), red cell distribution width (RDW), platelets (PLT) and mean platelet volume (MPV).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Immediately after dissection
- Animals fasted: Not specified
- How many animals: All
- Parameters: Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Creatinine (CRE), Urea (BUN), glucose (GLU), Na+, K+, Ca+2 and Cl-.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: No
HISTOPATHOLOGY: No - Statistics:
- Results were presented as mean ± S.E.M. One way analysis of variance (ANOVA) was used to determine significance between tests and controls. P-values less than 0.05 were considered significant.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - significant increase of WBC
CONCLUSION: no adverse effects - Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Conclusions:
- Under the test conditions, the NOAEL was concluded to be 100 mg/kg bw/day in rats.
- Executive summary:
In a 14 days dose toxicity study, the toxicological effects of aqueous suspensions of the resin of Commiphora molmol on Wister albino rats were studied. Two groups of each five animals were treated with 50 and 100 mg/kg/day by drinking water for 14 consecutive days. The mean body weights, hematological and biochemical analysis were evaluated.
The mean body weights exhibited insignificant variations compared to the control group. Besides, no toxic symptoms or death were observed and they survived being active and healthy up to 14 days. These findings could be a good indicator for non-toxicity and safety of those plants at the doses of 50 and 100 mg/kg body weight per day. This assumption is supported by hematological and biochemical analysis which revealed no significant clinical changes. The interested finding is that the mean WBC counts increased significantly in rats administered C. molmol suspension. This means that C. molmol may activate the defense mechanism.
Under the test conditions, the NOAEL was concluded to be 100 mg/kg bw/day in rats.
Table 7.5.1/1: Mean rat's body weight after 14 days treatment
Plant | Dose mg/kg/day |
Pre-treatment (g) | Post-treatment (g) |
C. molmol | 50 | 190.4± 11.7 | 259.4±18.7 |
100 | 207.1± 11.5 | 266.7±9.5 | |
control | 0 | 196.8± 9.5 | 268.4± 23.1 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Table 7.5.1/2: Hematological studies on rats after 14 days treatment
Plant | Dose mg/kg/day |
WBC (×103/µl) |
RBC (×106/µl) |
HGB (g/dl) |
HCT (%) |
MCV (fl) |
MCH (pg) |
MCHC (g/dl) |
RDW (%) |
PLT (x103/µl) |
MPV (fl) |
C. molmol | 50 | 18.4± 1.0 | 8.6± 0.4 | 15.8± 0.9 | 49.4± 2.3 | 57.1± 0.6 | 18.3± 0.3 | 32.1± 0.3 | 14.7± 0.9 | 689.8± 46.0 | 9.3± 0.3 |
100 | 19.4± 1.6 | 8.2± 0.4 | 15.4± 0.9 | 47.0± 3.1 | 56.4± 1.6 | 18.6± 0.3 | 32.9± 0.3 | 14.3± 0.2 | 755.8± 19.8 | 8.9± 0.3 | |
control | 0 | 12.2± 0.7 | 7.8± 0.4 | 14.8± 0.6 | 45.3± 1.7 | 58.0± 1.3 | 19.0± 0.3 | 32.7± 0.3 | 14.7± 0.3 | 757.0± 58.3 | 9.4± 0.5 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Table 7.5.1/3: Biochemical studies on rats after 14 days treatment
Plant | Dose mg/kg/day |
GLU mmol/l |
BUN mmol/l |
CRE Umol/l |
AST U/l |
ALT U/l |
ALP U/l |
Na+ mmol/l |
K+ mmol/l |
CA2+ mmol/l |
Cl- mmol/l |
C. molmol | 50 | 16.9± 1.8 | 6.5± 0.4 | 53.4± 3.5 | 158.6± 1.4 | 91.2± 14.4 | 441.6± 68.7 | 142± 1,3 | 10.5± 1.0 | 3.4± 0.1 | 94.4± 0.6 |
100 | 17.7± 1.7 | 5.9± 0.2 | 57.8± 3.5 | 150.4± 21.4 | 98.4± 21.3 | 589.4± 44.7 | 143.4± 0.9 | 11.1± 1.0 | 3.4± 0.1 | 95.0± 1.0 | |
control | 0 | 15.0± 1.9 | 6.6± 0.6 | 55.2± 2.2 | 150.2± 15.8 | 72.6± 9.2 | 319.2± 12.5 | 143.2± 0.9 | 9.75± 0.9 | 3.3± 0.04 | 95.0± 0.6 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
The mean body weights exhibited insignificant variations compared to the control group. Besides, no toxic symptoms or death were observed and they survived being active and healthy up to 14 days. These findings could be a good indicator for non-toxicity and safety of those plants at the doses of 50 and 100 mg/kg body weight per day. This assumption is supported by hematological and biochemical analysis which revealed no significant clinical changes. The interested finding is that the mean WBC counts increased significantly in rats administered C. molmol suspension. This means that C. molmol may activate the defense mechanism.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Study performed similarly to the OECD TG 407 with major deviations (only weight, haematology and biochemistry investigations were performed)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- number of animals per group, age of animals, absence of satellite group; only weight, hematological and biochemical examination
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- "Wister albino"
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: 3-4 months
- Weight at study initiation: 150-250 g, The mean weight of rats have been estimated from 10 randomly selected rats and was found to be 198.0 g
- Fasting period before study: not reported
- Housing: Rats were divided into five individuals for each group and allocated randomly in separate clean and well ventilated cages.
- Diet : standard pellet diet purchased from ARASCObCompany, KSA.
- Water : The drinking water for treated animals mixed with the required doses of test substance, ad labium
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C.
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark cycle
IN-LIFE DATES: no reported - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Depending on the fact that the mean water consumption of rats is 25 ml/day, the required doses have been calculated according to the followings:
Given dose = [ Required dose (mg) × Mean weight of rats (g) ] / 1000 (g)
Accordingly, the amount of plant powders that should be suspended in rat's drinking water (per liter) has been calculated as the following equation:
Amount = [ Dose × 1000 ml ] / 25 ml - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 successful days
- Frequency of treatment:
- Exposure via drinking water, i.e. several times per day
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 animals / group (male and female)
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: No preliminary study was performed to determine the dose selection for the 28-days study. However, a 14-days treatment study was performed. The animals were treated with 50 and 100 mg/kg bw/d. No clinical signs, no death, and no significant variation of hematological and biochemical parameters were observed.
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: once pre-treatment and once thereafter at termination
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Immediately after dissection
- Anaesthetic used for blood collection: No. Animals were euthanized with diethyl ether before collecting blood
- Animals fasted: Not specified
- How many animals: All (5/group)
- Parameters: white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), red cell distribution width (RDW), platelets (PLT) and mean platelet volume (MPV).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Immediately after dissection
- Animals fasted: Not specified
- How many animals: All
- Parameters: Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Creatinine (CRE), Urea (BUN), glucose (GLU), Na+, K+, Ca+2 and Cl-.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: No
HISTOPATHOLOGY: No - Statistics:
- Results were presented as mean ± S.E.M. One way analysis of variance (ANOVA) was used to determine significance between tests and controls. P-values less than 0.05 were considered significant.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- significant decrease in mean body weights
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- no significant differences, only the mean MPV revealed significant increase when compared to the control group
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - decrease of serum glucoses (not-fasting)
- significant decrease of Cl-
- significant increase of CRE and BUN
- significant increase of AST - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- haematology
- Key result
- Critical effects observed:
- no
- Conclusions:
- Under the test conditions, the NOAEL can be concluded to be 500 mg/kg bw/day in rats
- Executive summary:
In a repeated dose toxicity study, the toxicological effects of aqueous suspensions of the resin of C. molmol on Wister albino rats were studied. Three groups of each five animals were treated with 250, 500 and 1000 mg/kg/day by drinking water for 28 consecutive days. The mean body weights, hematological and biochemical analysis were evaluated.
The treatment results of either C. molmol suspensions revealed significant decrease in mean body weights, which may be a preliminary and sensitive index of toxicity after exposure to toxic substances. However, no toxic symptoms or deaths were found and they survived being active and healthy for up to 28 days.
The hematological analysis results of the rat groups administered C. molmol suspension exhibited no significant differences, only the mean MPV revealed significant when compared to the control group.
The biochemical parameters of rat’s serum revealed significant differences between the test and control group. The decrease of serum glucoses (not-fasting) may be due to alternation in carbohydrate metabolism. Cl- were significantly decreased, CRE and BUN exhibited significant increase, which could be an indicator for the negative impact on kidney functions. Kidney functions were evaluated by means of serum urea and creatinine levels. AST were significantly increased, implying negative impact on liver functions. The two enzymes mainly associated with hepatocellular damage in liver are AST and ALT. However, AST is present in a wide variety of tissues including heart, skeletal muscles, kidney, brain and liver. Therefore, the significant increase of AST in rats treated with C. molmol may be due to the release of enzymes from the cells of the affected organs, or to change in cell membrane permeability. Other biochemical parameters showed insignificant differences in comparison with the control group.
The treatment results of C. molmol suspensions revealed significant decrease in mean body weights, beside variations in some hematological and biochemical parameters, particularly at high doses.
Under the test conditions, the NOAEL can be concluded to be 500 mg/kg bw/day in rats.
The test material is therefore not classified for damage to organs through prolonged oral repeated exposure according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
Table 7.5.1/1: Mean rat's body weight after 28 days treatment
Plant | Dose mg/kg/day |
Pre-treatment (g) | Post-treatment (g) |
C. molmol | 250 | 178.6± 13.5 | 275.4± 13.4 |
500 | 178.0± 6.1 | 266.4± 7.1 | |
1000 | 192.1± 15.6 | 236.1± 15.6 | |
control | 0 | 196.8± 9.5 | 324.5± 13.6 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Table 7.5.1/2: Hematological studies on rats after 28 days treatment
Plant | Dose mg/kg/day |
WBC (×103/µl) |
RBC (×106/µl) |
HGB (g/dl) |
HCT (%) |
MCV (fl) |
MCH (pg) |
MCHC (g/dl) |
RDW (%) |
PLT (x103/µl) |
MPV (fl) |
C. molmol | 250 | 12.9± 2.1 | 8.1± 0.3 | 15.9± 0.3 | 47.3± 2.3 | 58.0± 0.6 | 19.5± 0.4 | 33.7± 0.3 | 14.6± 0.5 | 659.8± 64.2 | 8.2± 0.3 |
500 | 11.6± 2.1 | 8.0± 0.3 | 14.5± 0.6 | 44.3± 1.8 | 54.9± 1.4 | 18.0± 0.3 | 32.7± 0.4 | 14.7± 0.4 | 728.4± 54.9 | 7.7± 0.4 | |
1000 | 9.9± 1.5 | 7.7± 0.4 | 14.7± 0.5 | 43.4± 1.8 | 56.1± 0.9 | 19.1± 0.4 | 33.9± 0.3 | 14.0± 0.2 | 756.4± 43.5 | 8.2± 0.4 | |
control | 0 | 12.2± 0.7 | 7.8± 0.4 | 14.8± 0.6 | 45.3± 1.7 | 58.0± 1.3 | 19.0± 0.3 | 32.7± 0.3 | 14.7± 0.3 | 757.0± 58.3 | 9.4± 0.5 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Table 7.5.1/3: Biochemical studies on rats after 28 days treatment
Plant | Dose mg/kg/day |
GLU mmol/l |
BUN mmol/l |
CRE Umol/l |
AST U/l |
ALT U/l |
ALP U/l |
Na+ mmol/l |
K+ mmol/l |
CA2+ mmol/l |
Cl- mmol/l |
C. molmol | 250 | 11.8± 1.4 | 5.7± 0.1 | 50.2± 2.7 | 167.2± 34.7 | 91.6± 12.8 | 308.4± 43.5 | 142.4± 1.2 | 10.9± 1.0 | 3.3± 0.1 | 93.8± 0.8 |
500 | 10.7± 1.2 | 7.6± 0.4 | 60.4± 2.2 | 195.8± 5.3 | 100.4± 16.8 | 312.2± 36.3 | 140.6± 0.6 | 11.2± 1.0 | 3.5± 0.1 | 90.2± 0.5 | |
1000 | 8.5± 0.6 | 9.3± 0.7 | 61.0± 2.8 | 225.6± 26.3 | 102.6± 22.0 | 316.0± 36.3 | 141.2± 1.2 | 11.4± 0.7 | 3.3± 0.1 | 91.8± 0.5 | |
control | 0 | 15.0± 1.9 | 6.6± 0.6 | 55.2± 2.2 | 150.2± 15.8 | 72.6± 9.2 | 319.2± 12.5 | 143.2± 0.9 | 9.75± 0.9 | 3.3± 0.04 | 95.0± 0.6 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
The treatment results of either C. molmol suspensions revealed significant decrease in mean body weights, which may be a preliminary and sensitive index of toxicity after exposure to toxic substances. However, no toxic symptoms or deaths were found and they survived being active and healthy for up to 28 days.
The hematological analysis results of the rat groups administered C. molmol suspension exhibited no significant differences, only the mean MPV revealed significant when compared to the control group.
The biochemical parameters of rat’s serum revealed significant differences between the test and control group. The decrease of serum glucoses (not-fasting) may be due to alternation in carbohydrate metabolism. Cl- were significantly decreased, CRE and BUN exhibited significant increase, which could be an indicator for the negative impact on kidney functions. Kidney functions were evaluated by means of serum urea and creatinine levels. AST were significantly increased, implying negative impact on liver functions. The two enzymes mainly associated with hepatocellular damage in liver are AST and ALT. However, AST is present in a wide variety of tissues including heart, skeletal muscles, kidney, brain and liver. Therefore, the significant increase of AST in rats treated with C. molmol may be due to the release of enzymes from the cells of the affected organs, or to change in cell membrane permeability. Other biochemical parameters showed insignificant differences in comparison with the control group.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological assessment of the oleo-gum resins of Commiphora molmol and Boswellia papyrifera in rats
- Author:
- Abdallah et al.
- Year:
- 2 009
- Bibliographic source:
- Journal of Medicinal Plants Research Vol. 3(6), pp. 526-532, July, 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- 2 test groups, sex allocation per groups is not known, 24h observation period, no details on composition of the test substance
- GLP compliance:
- not specified
- Remarks:
- this information is not reported in the publication
- Test type:
- standard acute method
- Limit test:
- no
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: purchased from traditional medicine shops from Al Rass town, Saudi Arabia
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- "Wister albino rats"
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: 3-4 months
- Weight at study initiation: 150-250 g, The mean weight of rats have been estimated from 10 randomly selected rats and was found to be 198.0 g
- Fasting period before study: not reported
- Housing: Rats were divided into five individuals for each group and allocated randomly in separate clean and well ventilated cages.
- Diet : standard pellet diet purchased from ARASCObCompany, KSA.
- Water : The drinking water
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C.
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark cycle
IN-LIFE DATES: no reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not reported. The required doses of the plant’s resins were suspended in 5 ml distilled water and administered orally using long-mouth syringe.
- Amount of vehicle (if gavage): 5 mL
- Justification for choice of vehicle: not reported
MAXIMUM DOSE VOLUME APPLIED: not reported
- Doses:
- 1000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 24h
- Frequency of observations and weighing: observations at least after 6h and 24h
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight: once before treatment and thereafter at termination, other: hematological and biochemical analysis - Statistics:
- Results were presented as mean ± S.E.M. One way analysis of variance (ANOVA) was used to determine significance between tests and controls. P-values less than 0.05 were considered significant.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- other: test material in suspension
- Mortality:
- none reported
- Clinical signs:
- other: - 1000 and 5000 mg/kg bw: after 6h, a symptom of weakness and decrease in moving activity is observed. These symptoms increased on the next day. Reduction in motion activity and weakness observed may be due to the fragrant resins and volatile oils and oth
- Other findings:
- The hematological and biochemical parameters of the rat groups that administered high-dose oral single dose of either C. molmol suspensions exhibited serous significant variations. It is known that at higher concentrations, the toxic effects become manifest owing to the physiopharmacological interactions. Animals that administered C. molmol suspension showed significant increase in MCH and MCHC. While RDW and MPV showed significant decrease, while other hematological parameters were insignificant. As well, the biochemical analysis results revealed significant increase in BUN and K+ ions, beside significant decrease in Na+ and Ca+2 ions, whereas other biochemical parameters were insignificant in comparison with the control group.
Any other information on results incl. tables
Table 7.2.1/1: Hematological studies on rats after single dose treatment
Plant | Dose mg/kg/day |
WBC (×103/µl) |
RBC (×106/µl) |
HGB (g/dl) |
HCT (%) |
MCV (fl) |
MCH (pg) |
MCHC (g/dl) |
RDW (%) |
PLT (x103/µl) |
MPV (fl) |
C. molmol | 1000 | 9.9±0.9 | 8.7± 0.4 | 15.7± 0.5 | 48.8± 1.9 | 55.0± 0.6 | 18.0± 0.2 | 32.2± 0.2 | 15.4± 0.9 | 876.8± 119.1 | 6.9± 0.1 |
5000 | 8.4± 1.0 | 8.8± 0.1 | 16.7± 0.2 | 50.6± 0.9 | 58.0± 0.3 | 19.4± 0.1 | 33.5± 0.2 | 12.3± 0.4 | 924.0± 95.3 | 6.3± 0.1 | |
control | 0 | 12.2± 0.7 | 7.8± 0.4 | 14.8± 0.6 | 45.3± 1.7 | 58.0± 1.3 | 19.0± 0.3 | 32.7± 0.3 | 14.7± 0.3 | 757.0± 58.3 | 9.4± 0.5 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Table 7.2.1/2: Biochemical studies on rats after single dose treatment
Plant | Dose mg/kg/day |
GLU mmol/l |
BUN mmol/l |
CRE Umol/l |
AST U/l |
ALT U/l |
ALP U/l |
Na+ mmol/l |
K+ mmol/l |
CA2+ mmol/l |
Cl- mmol/l |
C. molmol | 1000 | 10.3±1.6 | 9.8± 1.5 | 43.2± 2.9 | 184.4± 9.8 | 70.6± 16.2 | 247.4± 38.0 | 126.2± 2.5 | 19.4± 1.6 | 2.67± 0.02 | 92.8± 1.3 |
5000 | 13.6± 2.6 | 11.5± 3.0 | 49.2± 5.1 | 162.5± 17.3 | 84.0± 14.8 | 357.2± 44.1 | 127.0± 3.0 | 21.5± 2.3 | 2.81± 0.05 | 94.2± 1.1 | |
control | 0 | 15.0± 1.9 | 6.6± 0.6 | 55.2± 2.2 | 150.2± 15.8 | 72.6± 9.2 | 319.2± 12.5 | 143.2± 0.9 | 9.75± 0.9 | 3.3± 0.04 | 95.0± 0.6 |
Data presented as mean ± S.E.M., n = 5, significantly different from control: P < 0.05.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 > 5000 mg/kg bw
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, groups of Wister albino rats (5/dose) were administered a single oral dose of aqueous suspensions of the resin of Commiphora molmol at 1000 or 5000 mg/kg bw/day. Animal were then observed for mortality, clinical signs, body weights, hematological and biochemical analysis for one day.
No mortality was reported during the 24h observation period. Weakness and decrease in motion activity were observed at 5000 mg/kg bw in addition to significant variations in some hematological and biochemical parameters compared to the control group.
The acute oral LD50 is considered to be higher than 5000 mg/kg bw.
Under the test conditions, the substance is not classified for acute oral toxicity according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
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