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EC number: 430-380-7 | CAS number: 445409-27-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under EU Guideline under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Molyvan 855 (OD-855)
- IUPAC Name:
- Molyvan 855 (OD-855)
- Reference substance name:
- -
- EC Number:
- 430-380-7
- EC Name:
- -
- Cas Number:
- 445409-27-8
- Molecular formula:
- Cannot be assigned due to being a complex reaction mixture
- IUPAC Name:
- Amides, coco, N, N-bis(hydroxyethyl), reaction products with coco monoglycerides and molybdenum oxide
- Details on test material:
- Description: Dark brown paste
Date received: 6 January 1997
Storage conditions: room temperature in the dark
Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Charles River (UK) Limited, Manston, Kent.
- Age at study initiation:
Five to six weeks old.
- Weight at study initiation:
The males weighed 128 to 157g, and the females weighed 117 to 141g.
- Fasting period before study:
- Housing:
The animals were housed in a single air-conditioned room in groups of five by sex in polypropylene grid-floor cages suspended over trays lined with absorbent paper.
- Diet:
ad libitum
- Water:
ad libitum
- Acclimation period:
The animals were acclimated for seven days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
The temperature was controlled to remain within target ranges of 21 +/- 2 deg C.
- Humidity (%):
The humidity was controlled to remain with target ranges of 55 +/- 15%.
- Air changes (per hr):
The rate of air exchange was at least fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light):
The low intensity fluorescent lighting was controlled to give twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- BP
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The volume of test and control material administered to each animal was based on the most recent bodyweight and was adjusted at weekly intervals.
Stability and homogeneity of the test material formulations were determined by Safepharm. Formulations were stable for 14-days and were therefore, prepared weekly and stored at approximately 4 degrees C in the dark.
VEHICLE
- Amount of vehicle (if gavage):
4ml/kg/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were taken of each test material formulation and were analysed for concentration of Molyvan 855 (Oil Free) at Safepharm. The results indicate that the prepared formulations were within + or - 10% of the nominal concentration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
15
Basis:
other: mg/kg/day
- Remarks:
- Doses / Concentrations:
150
Basis:
other: mg/kg/day
- Remarks:
- Doses / Concentrations:
1000
Basis:
other: mg/kg/day
- No. of animals per sex per dose:
- Dose level 15 mg/kg/day
5 male
5 female
Dose level 150 mg/kg/day
5 male
5 female
Dose level 1000 mg/kg/day
5 male
5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
Dose selection was based on results from the range finding 14-day study in rats following Oral (gavage) administration. The test material was tested up to the maximum tolerated dose level (1000 mg/kg/day). This information was used to determine the dose levels for this study.
The volume of test and control material administered to each animal was based on the most recent bodyweight and was adjusted at weekly intervals.
The test material was administered daily, for twenty-eight consecutive days, by gavage using a stainless steel cannula attached to a disposable plastic syringe.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
Animals were observed immediately before dosing and one hour after dosing at weekends and public holidays.
BODY WEIGHT: Yes
- Time schedule for examinations:
Individual bodyweights were recorded on Day 0 (the day before the start of the treatment) and on Days 7, 14, 21 and 28. Bodyweights were also recorded at terminal kill.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
Food consumption was recorded for each cage group at weekly intervals throughout the study.
WATER CONSUMPTION:
Daily visual inspection of water bottles from Week 2 onwards revealed possible intergroup differences. Water consumption was therefore, measured and recorded for each cage group from Day 22 onwards.
HAEMATOLOGY: Yes
- Time schedule for collection of blood:
Day 28.
- Animals fasted: No
- Parameters checked:
Haemoglobin (HB)
Erythrocyte count (RBC)
Haematocrit (Hct)
Erythrocyte indices - mean corpuscular haemoglobin (MCH)
- mean corpuscular volume (MCV)
- mean corpuscular haemoglobin concentration (MCHC)
Total leucocyte count (WBC)
Differential leucocyte count - neutrophils (Neut)
- lymphocytes (Lymph)
- monocytes (Mono)
- eosinophils (Eos)
- basophils (Bas)
Platelet count (PLT)
Clotting (prothrombin) time (CT) was assessed by 'Hepato Quick' using samples collected into sodium cirate solution (0.11 mol/l).
BLOOD CHEMISTRY: Yes
- Parameters checked:
Urea
Lucose
Total protein (Tot.Prot)
Albumin
Albumin/Globulin (A/G) ratio (by calculation)
Sodium (Na+)
Potassium (K+)
Chloride (Cl-)
Calcium (Ca++)
Inorganic phosphorus (P)
Aspartate aminotransferase (ASAT)
Alanine aminotransferase (ALAT)
Alkaline phosphatase (AP)
Creatinine (Creat)
Total bilirubin (Bili) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
On completion of the dosing period all animals were killed by intravenous sodium pentobarbitone (Sagatal, 60 mg/ml) followed by exsanguination.
All animals were subjected to a full external and internal examination, and any macroscopic abnormalities were recorded.
Organ weights
The following organs, removed from animals that were killed at the end of the study, were dissected free from fat and weighed before fixation:
Adrenals, Gonads, Kidneys, Brain, Heart, Liver, Spleen.
HISTOPATHOLOGY: Yes
Samples of the following tissues were removed from all animals and preserved in buffered 10% formalin:
Adrenals
Aorta (thoracic)
Bone & bone marrow (femur including stifle joint)
Bone & bone marrow (sternum)
Brain
Caecum
Colon
Duodenum
Eyes
Gross lesions
Heart
Ileum
Jejunum
Kidneys
Liver
Lungs (with bronchi)
Lymph nodes (cervical and mesenteric)
Muscle (skeletal)
Oesophagus
Ovaries
Pancreas
Pituitary
Prostate
Rectum
Salivary glands (submaxillary)
Sciatic nerve
Seminal vesicles
Skin (hind limb)
Spleen
Stomach
Testes (with epididymides)
Thymus
Thyroid/parathyroid
Trachea
Urinary bladder
Uterus
All tissues were despatched to Finn International UK for processing. The following preserved tissues from all control and 1000 mg/kg/day dose group animals were prepared as paraffin blocks, sectioned at nominal thickness of 5 micro m and stained with haematoxylin and easin for subsequent microscopic examination:
Adrenals, Heart, Kidneys, Liver, Spleen, Testes
The liver and spleen from all 15 and 150 mg/kg/day dose group animals were also processed.
Since there were indications of treatment-related renal changes examination was subsequently extended to include similarly prepared sections of kidney from all animals in the remaining groups.
Microscopic examination was conducted by the Study Pathologist, All finding were entered into the ROELEE 84 pathology computerisation system for tabulation and report production. - Statistics:
- Data were processed to give group mean values and standard deviations where appropriate. Bodyweight gain, haematological, blood chemical and organ weight (absolute and relative to terminal bodyweight) data, were assessed for dose response relationships using linear regression analysis. Data showing a significant dose response were analysed for homogeneity of variance using Levene's test. Data showing homogeneous variances were analysed by one way analysis of variance (ANOVA) and pairwise comparisons were made using Dunnett's test. Data showing heterogeneous variances were re-analysed using Kruskal-Wallis non-parametric analysis of variance and Mann-Whitney U-test.
The haematology variable basophils was not analysed since consistently greater than 30% of the data were recorded as the same value.
Probability values (p) are presented as follows:
p <0.001***
p <0.01**
p <0.05*
p>= 0.05 (not significant)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
There were no deaths during the study. No clinically observable signs of toxicity were detected in test or control animals throughout the study period.
Animals of either sex treated with 1000 mg/kg/day showed increased salivation approximately two minutes after dosing from Day 8 onwards, followed by occasional incidents of increased salivation noted up to one hour after dosing from Day 15. Red/brown staining and/or wetting of the external body surface were also apparent in 1000 mg/kg/day animals from Day 5 onwards together with an isolated incidence of noisy respiration detected on Day 8 only. Such observations are often reported when the test material formulation has an unpleasant taste or is slightly irritant and, in isolation, were considered not to be indicative of systemic toxicity.
Animals of either sex treated with 150 or 15 mg/kg/day showed no such clinical signs throughout the study.
Isolated incidents of fur staining were observed but these were confined to two control males and, as such, were incidental.
BODY WEIGHT AND WEIGHT GAIN
Males treated with 1000 mg/kg/day showed a statistically significant reduction in bodyweight gain from Week 2 onwards, with one male showing a bodyweight loss at Day 28.
No adverse effect on bodyweight development was detected for females treated with 1000 mg/kg/day or for animals of either sex treated with 150 or 15 mg/kg/day throughout the study.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
FOOD EFFICIENCY:
Males treated with 1000 mg/kg/day showed a slight reduction in dietary intake and food efficiency (the ratio of weight gain to food consumption) from Week 2 onwards when compared with that of controls. No such effects were detected for females treated with 1000 mg/kg/day or for animals of either sex treated with 150 or 15 mg/kg/day throughout the study.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study):
Quantitative measurement revealed an increase in water consumption for animals of either sex treated with 1000 mg/kg/day compared with controls. The effect was more pronounced amongst males than females. No adverse effect on water intake was detected at 150 or 15 mg/kg/day throughout the study.
HAEMATOLOGY
There were no toxicologically significant changes in the haematological parameters measured.
A slight, but significant reduction (
BLOOD CHEMISTRY
There were no toxicologically significant changes in the blood chemical parameters measured.
Males from all treatment groups showed a slight but statistically significant (p <0.05) increase in aspartate aminotransferase compared with controls. All individual values were within the normal range for rats of the age and strain employed and, in the absence of a convincing dose-relationship, the increase was considered to be irrelevant.
The remaining statistically significant intergroup differences (an increase in 1000 mg/kg/day male plasma creatinine and a reduction in 1000 mg/kg/day female bilirubin) were confined to isolated, minimal (p <0.05) changes where all individual values were within the respective normal ranges. Such changes were, therefore, considered to be without toxicological importance.
ORGAN WEIGHTS
Animals of either sex treated with 1000 mg/kg/day showed a substantial increase in group mean kidney weight, both absolute and relative to terminal bodyweight compared with controls, with one male absolute weights not achieving statistically significance. Nine out of the ten individual relative kidney weights were outside the respective normal ranges for rats of the strain and age employed.
No such effects were detected at 150 or 15 mg/kg/day.
GROSS PATHOLOGY
Three animals of either sex treated with 1000 mg/kg/day showed pale kidneys at terminal kill.
No macroscopic abnormalities were observed at 150 or 15 mg/kg/day.
One male treated with 1000 mg/kg/day showed hydronephrosis of the left kidney at terminal kill but this finding represents a common, spontaneously-arising congenital conditions amongst laboratory maintained rats of the strain and age used in the study and was of no toxicological importance.
HISTOPATHOLOGY: NON-NEOPLASTIC
Treatment-related renal changes were observed. The incidence and severity of groups of basophilic cortical tubules were increased in relation to treatment for rats of either sex dosed at 1000 mg/kg/day.
Treated animals from the remaining dose groups were unaffected.
All remaining morphological changes were those commonly observed in laboratory maintained rats of the age and strain employed and there were no differences in incidence or severity between control and treatment groups that were considered to be of toxicological significance.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxicologically significant effects were detected at 150 or 15 mg/kg/day and the NOAEL was, therefore, considered to be 150 mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In an EU Method B.7 study 28-day repeated dose oral study in Sprague-Dawley rats, the NOAEL of Molyvan 855 is 150 mg/kg/day.
- Executive summary:
Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of up to 1000 mg/kg/day, resulted in toxicologically significant effects at the highest dose level. No such effects were detected at 150 or 15 mg/kg/day and the No Observed Effect Level (NOEL) and No Observed Adverse Effect Level (NOAEL) was, therefore, considered to be 150 mg/kg/day.
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