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EC number: 236-031-3 | CAS number: 13106-76-8
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of thiomolybdate and ammonium molybdate in pregnant guinea pig and their offspring
- Author:
- J.Mcc Howell,Y.Shunxiang, J.M.Gawthorne
- Year:
- 1 993
- Bibliographic source:
- Research in veterinary science, 1993, 55, 224-230
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Reproductive study of ammonium molybdate was performed on guinea pig.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium molybdate(VI)
- EC Number:
- 236-031-3
- EC Name:
- Ammonium molybdate(VI)
- Cas Number:
- 13106-76-8
- Molecular formula:
- H4N.1/2MoO4
- IUPAC Name:
- ammonium molybdate(VI)
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: Mature
- Weight at study initiation: Female :500g and male:600g
- Fasting period before study: No data available
- Housing: Galvanized metal mesh cage
- Diet (e.g. ad libitum): Milne feeds containing 212µmol /kg Cu(ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Remarks:
- Distilled
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material was added in distilled water
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): water
- Concentration in vehicle: 0 and 5.11 mg/kg
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage:1:1
- Length of cohabitation: For each female ,male was introduced into cage twice a day for 8.00 to 10.00 and 19.00 and 21.00
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: If copulation plug was found under the cage and /or sperm were detected in vaginal smear referred to as day 0.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility :No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)]:No data available
- After successful mating each pregnant female was caged (how): Individually
- Any other deviations from standard protocol:No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Approx 63 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 5.115 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 12
0 mg/kg bw: 6
5.115 mg/kg bw: 6 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily for aborted fetuses
- Cage side observations checked in table [No.?] were included. No data available
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: as per autopsy schedule
BODY WEIGHT: Yes
- Time schedule for examinations: body weight of dams and pups were recorded each week.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OTHER: In per-mating period all the animals’ received tap water containing 1 g L- ascorbic acid /L /day. After mating in treated group received 16mg L- ascorbic acid /L/day while neonatal guinea pig received 4mg L- ascorbic acid/day in 0.125 ml distilled water up to 14 days old and there after 8mg L- ascorbic acid/day in 0.25ml distilled water until 6 weeks old . - Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Viability,clinical signs, Body weight and weight gain were examined.
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: yes
- Maternal animals: yes ( All the animals were anaesthetised with diethyl ether and blood was withdrawn by cardiac puncture into heparinised tubes and animals killed )
GROSS NECROPSY:
- No data available
HISTOPATHOLOGY / ORGAN WEIGHTS:
Pancreas of two dams in each group were examined - Postmortem examinations (offspring):
- SACRIFICE
-At birth 2 animals of each litter were retained with dam for 6 weeks then both pups were killed. Young in excess of 2 were killed at birth.
GROSS NECROPSY: No data available
HISTOPATHOLOGY / ORGAN WEIGTHS: Sample of liver ,kidney ,sciatic nerve, gastrocnemius muscle, femur ,brain , spinal cord were carried out - Statistics:
- Statistics was done using two sample t test using equal and unequal variances.
- Reproductive indices:
- No data available
- Offspring viability indices:
- Yes, on day 0, 4 and 6 weeks.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical sign of toxicity were observed in treated rats as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated rats as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of treated female rats were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant change were observed on RBC, haemoglobin and mean corpuscular haemoglobin concentration in treated rats as compared to control.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant histological changes were in pancreas such as atrophy, lysis of single cells, loss of acinar pattern and vacuolation of acinar cells.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect on estrous cycle of treated rats were observed as compared to control.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Number pregnant, Aborted resorbing, Stillborn and Born alive in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 5.115 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- haematology
- gross pathology
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- No effect on viability of pups were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups at week 6 were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant change were observed on RBC, haemoglobin and mean corpuscular haemoglobin concentration in treated rats as compared to control.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Significant histological changes were in pancreas such as atrophy, lysis of single cells, loss of acinar pattern and vacuolation of acinar cells in six weeks old pups.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 5.115 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- haematology
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Clinical signs and deaths in adult guinea pigs
Group |
A |
B |
C |
D |
E |
F |
|
Before and after mating |
After mating |
||||
Treatment |
Control |
AM |
TM |
TM |
TM |
TM |
µmol litre -1 |
0 |
261 |
261 |
130 |
261 |
130 |
Number in group |
8 |
8 |
8 |
8 |
8 |
8 |
Loss of hair around mouth and ears |
0 |
0 |
6 |
0 |
4 |
0 |
Transient diarrhea |
0 |
0 |
1 |
0 |
4 |
0 |
Died pregnant |
0 |
0 |
2 |
0 |
3 |
0 |
Died non pregnant |
0 |
0 |
1 |
1 |
0 |
1 |
Killed during pregnancy |
0 |
0 |
1 |
2 |
5 |
0 |
Ossified ridge in animals killed |
0/8 |
0/8 |
3/5 |
0/7 |
4/5 |
1/7 |
Reproductive performance and viability of offspring of guinea pigs given AM or TM
Group |
A |
B |
C |
D |
E |
F |
|
Before and after mating |
After mating |
||||
Treatment |
Control |
AM |
TM |
TM |
TM |
TM |
µmol litre -1 |
0 |
261 |
261 |
130 |
261 |
130 |
Adults |
|
|
|
|
|
|
Number in group |
8 |
8 |
8 |
8 |
8 |
8 |
Number pregnant |
7 |
4 |
6 |
6 |
8 |
6 |
Fetuses |
|
|
|
|
|
|
Number |
23 |
12 |
16 |
21 |
21 |
19 |
Aborted resorbing |
0 |
0 |
9 |
0 |
15 |
0 |
Stillborn |
2 |
2 |
4 |
11 |
6 |
1 |
Born alive |
21 |
10 |
3 |
10 |
0 |
18 |
Pups killed at 6 weeks |
|
|
|
|
|
|
Number of pups killed |
14 |
7 |
3 |
8 |
|
|
Weight at birth (g) (SE) |
114-4 (4.3) |
116.0 (2.3) |
107.6 (3.1) |
108.8 (3.3) |
NA |
106.1 (9.7) |
Weight gain (g) from birth (SE) |
3642 (31.3) |
376.9 (12.7) |
317.4 (28.1) |
343.5 (36.4) |
NA |
407.6 (21.1) |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 5.115 mg/kg bw when Hartley Albino female guinea pig were treated with ammonium molybdate orally in drinking water approx. 63 days.
- Executive summary:
In Reproductive toxicity test, Hartley Albino female guinea pig were treated with ammonium molybdate in the concentration of 0 and 5.115 mg/kg bw orally in drinking water. No mortality, clinical sign, change in body weight, no change in RBC, haemoglobin and mean corpuscular haemoglobin concentration and gross pathology were observed in treated rats as compared to control. Similarly, no effect on estrous cycle, Number pregnant, aborted resorbing, Stillborn and Born alive in treated rats as compared to control. Significant histological changes were in pancreas such as atrophy, lysis of single cells, and loss of acinar pattern and vacuolation of acinar cells. In addition, No effect on viability, body weight and hematology of pups were observed as compared to control. Significant histological changes were in pancreas such as atrophy, lysis of single cells, and loss of acinar pattern and vacuolation of acinar cells in six weeks old pups. The effects on pancreas were considered to result from copper deficiency rather than molybdenum toxicity. Therefore, NOAEL was considered to be 5.115 mg/kg bw when Hartley Albino female guinea pig were treated with ammonium molybdate orally in drinking water approx. 63 days.
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