Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-287-1 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not indicated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from a substance that is less bioavailable than Barium Chromate. Publication with unknown GLP study status and limited details. However the test is similar to guideline OECD 474 / EC B.12 and its sensitivity is validated by the positive result obtained.
Data source
Reference
- Reference Type:
- publication
- Title:
- In Vivo Clastogenicity of Lead Chromate in Mice
- Author:
- Watanabe M, Takayama Y, Koike M et al
- Year:
- 1 985
- Bibliographic source:
- Tohoku J Exp Med. 1985 Jul;146(3):373-4
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No details
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Lead chromate
- IUPAC Name:
- Lead chromate
- Details on test material:
- - Name of test material (as cited in study report): lead chromate
- Molecular formula (if other than submission substance): PbCrO4
- Analytical purity: 92%
- No other details available
- Surrogate PbCrO4 is used, instead of proposing a new test on the registered substance (with 15% of BaCrO4, source of CrVI) because:
. both BaCrO4 and PbCrO4 contain the chromate ion (CrO4--) which is the source of CrVI (mutagen and carcinogen)
. MW of BaCrO4 and PbCrO4 are close: 253 and 323
. water solubilities of BaCrO4 and PbCrO4 are both at lowest end of all chromates: 4.4 mg/L (28°C)* and 0.58 mg/L (25°C)*
. compared MW and water solubility indicate that BaCrO4 should be a bit more bioavailable than PbCrO4, so that any positive result with the latter can be extrapolated to BaCrO4 and therefore to the registered substance
* Source of solubility data: Scientific Basis for Swedish Occupational Standards XXI. Criteria Group for Occupational Standards. Ed. Johan Montelius, National Institute for Working Life, S-112 79 Stockholm, Sweden. ISBN 91-7045-582-1, 2000.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
ENVIRONMENTAL CONDITIONS
IN-LIFE DATES:
all no data reported
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.5% gum arabic saline
- no other data reported - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
suspended in 0.5% gum arabic saline, which had been milliporefiltered. The chemical of 0.8 ml solution was administered i.p. - Duration of treatment / exposure:
- twice at a 24 hr-interval
- Frequency of treatment:
- twice at a 24 hr-interval
- Post exposure period:
- Examined 24h after 2nd administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5, 1, 2 and 4 g/kg
Basis:
other: PbCrO4 injected levels
- No. of animals per sex per dose:
- 10 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none (but test validated by positive result with test item)
Examinations
- Tissues and cell types examined:
- Bone marrow polychromatic and normochromatic erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: not indicated
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): see above
DETAILS OF SLIDE PREPARATION:
The mouse was killed by cervical dislocation and the femoral bone marrow submerged in calf serum was pushed off onto a glass slide to prepare the smear. After methanol fixation, the smears were stained by May-Grünwald and Giemsa solutions.
METHOD OF ANALYSIS:
Scoring micronucleated cells in 1000 each of polychromatocytes and normochromocytes and the ratio of polychromatocytes to normochromocytes (P/N ratio) on the slide was determined. - Evaluation criteria:
- not indicated
- Statistics:
- Welch test and t-test vs. control
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- from 1 g/kg
- Toxicity:
- yes
- Remarks:
- from 0.5 g/kg
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- no details published
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): % in polychromatocytes: 0.63, 1.01, 1.58, 1.44 and 1.95 at 0, 0.5, 1, 2 and 4 g/kg
no micronucleus induction in normochromatocytes.
- Ratio of PCE/NCE (for Micronucleus assay): 0.81, 0.34, 0.25, 0.16 and 0.08 at 0, 0.5, 1, 2 and 4 g/kg
- Appropriateness of dose levels and route:
Dose-levels: excessive myelotoxicity (i.e. ratio PCE/(PCE+NCE) less than 20% of controls) occured only at the top-dose, so control and three test item doses stay interpretable.
The appropriate route would be inhalative (a systemic availability of barium chromate has been demonstrated after inhalation),* but no validated or guideline-compliant assay exists for this route and the target tissue should not be bone marrow (too far from entry site). Otherwise, based on guideline EC B.12 / OECD 474, oral route can be excluded due to poor absorption.* Therefore intraperitoneal administration is the only appropriate route for exposure to the bone marrow.
*: see toxicokinetics under 7.1
- Statistical evaluation: doses indicated in previous paragraph are those with p<0.01 significant effect
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
These results strongly suggest that PbCrO4 administered i.p. to mice gives rise to chromosome damage (as shown by micronucleus induction) in bone marrow and suppressed hematopoiesis (as shown by decreased PCE/NCE ratio).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.