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EC number: 268-006-8 | CAS number: 67989-22-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 42535, molybdatephosphate salt.
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 August 2017 - 22 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Specific details on test material used for the study:
- Batch number: 982432
Purity: Preparation containing ≥80% UVCB (treat as 100%)
Storage conditions: Stored at ambient conditions in the dark (away from direct light) - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, France
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 10 weeks both male and female
- Weight at study initiation: Males: 331-431 g, Females: 179-245 g
- Housing: Cages with standard, granulated, S8-15 sawdust bedding (J. Rettenmaier & Söhne)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Five days after arrival and before the start of pre-test. After acclimatization period, the animals were subjected to a 15-day pre-test period.
DETAILS OF FOOD AND WATER QUALITY: Pelleted standard Teklad 2014C and 2914C rat/mouse maintenance diet ad libitum (supplied by Envigo RMS, S.L.)..
Pelleted standard Teklad 2018C rat/mouse maintenance diet (supplied by Envigo RMS, S.L.) ad libitum, for lactating females and pups (until sacrifice).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC
- Humidity (%): 30 and 70%
- Air changes (per hr): 15-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/12 hours dark. - Route of administration:
- oral: gavage
- Details on route of administration:
- For each dose group the order of administration was all males first and then all females. Each day of treatment the starting order was alternated between males and females.
Formulations were maintained under agitation between 5 to 24 hours (from start of agitation until the end of administration). - Vehicle:
- arachis oil
- Details on oral exposure:
- - PREPARATION OF DOSING SOLUTIONS:
The required amount of test item was weighed in a disposable container. Approximately 80% of the final volume requested of arachis oil was poured in another disposable container. The test item was transferred to the container with the arachis oil and the mixture poured into an ultra turrax or a homogenizer to achieve a homogeneous suspension. The suspension was
poured into a volumetric flask or test tube. The disposable container that contained the mixture with the remaining amount of vehicle was washed and the contents added to the flask or test tube to make up to the mark. An adjustment volume was first added to the volumetric container and then to the container containing the formulation to reach the final requested volume of the formulation. Finally, the suspension was submitted to magnetic stirring for 5-10 minutes before sampling for dilution.
- VEHICLE
- Lot/batch no. (if required): KMO9422, KM09047
- Purity: not specified - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 12-mL aliquots (in duplicate) were taken from each formulation to be analyzed. Each aliquot was taken from the formulation freshly prepared and poured into an amber glass vial. The second aliquot was considered as a contingency sample.
- Duration of treatment / exposure:
- 5-8 weeks
- Frequency of treatment:
- Once daily
- F0 males: Two weeks prior to mating start until the day before sacrifice (for five weeks of dosing). They were then killed.
- F0 females: Two weeks prior to mating start until day 13/15 of lactation, including the day before sacrifice.
- F1: Potential indirect exposure in utero and through the milk during lactation - Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control (Group 1)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Group 2
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- Group 3
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- Group 4
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: It was considered a suitable dose level range, based on the preliminary results obtained in the previous non-GLP study HJ88HL 14-day Oral (Gavage) Dose-Range Toxicity Study for OECD 422 conducted at Envigo CRS, S.A.U.
- The high dose was selected as no toxicity was observed in the preliminary study at 1000 mg/kg/day and considering it as a limit dose to be tested.
- Intermediate and low dose levels were selected considering approximately a 3-fold interval between doses.
- Rationale for animal assignment (if not random): Random - Positive control:
- none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once a week
BODY WEIGHT: Yes
- Time schedule for examinations:
- pre-test: once a week
- treatment: On day 1 and weekly thereafter
- mating: day 1
- post-mating: weekly
- gestation: On days: 0, 7, 14, 20
- Lactation: On days: 1, 4, 9 and 13
FOOD CONSUMPTION:
- Food consumption: Yes weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: Yes Isoflurane
- Animals fasted: Yes
- How many animals: Males:
- Group 1: 1, 2, 3, 4 and 5
- Group 2: 13, 14, 15, 16 and 17
- Group 3: 25, 26, 27, 28 and 29
- Group 4: 37, 38, 39, 40 and 41
Females:
- Group 1: 60, 63, 64, 66 and 67
- Group 2: 82, 74, 76, 83 and 79
- Group 3: 84, 85, 86, 87 and 88
- Group 4: 98, 99, 100, 101 and 102
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:
- Animals fasted: Yes
- How many animals: same as 'haematology'
NEUROBEHAVIOURAL EXAMINATION: Yes
- Dose groups that were examined: all
- Battery of functions tested: sensory activity, grip strength, motor activity,
Thyroid hormone analysis: T4 levels.
Day 4 of age Offspring: 2 females per litter
Day 13 of age Offspring: 2 males and 2 females per litter - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 1)
HISTOPATHOLOGY: Yes (see table 2) - Other examinations:
- not specified
- Statistics:
- yes
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- Critical effects observed:
- not specified
- Conclusions:
- Systemic toxicity:
− The No Observed Effect Level (NOEL) for systemic toxicity was considered to be 1000 mg/kg/day, taking into account that there was no effect on body weight, food consumption, clinical signs, clinical pathology, organ weights or histopathology.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline study Klimisch 1
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
PV3:4 is not classified for repeat dose toxicity and a STOT RE is not assigned
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