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EC number: 235-067-7 | CAS number: 12065-90-6
- 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:
- key study
- Study period:
- August-December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Lead monoxide
- EC Number:
- 215-267-0
- EC Name:
- Lead monoxide
- Cas Number:
- 1317-36-8
- Molecular formula:
- OPb
- IUPAC Name:
- lead monoxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Lead Oxide
- Name of test material (as cited in study report): Litharge-Lead Oxide
- Molecular formula (if other than submission substance): PbO
- Physical state: fine, yellow powder
- Analytical purity: 99.8%
- Composition of test material, percentage of components: PbO:99.8%; metallic Pb: <0.01; Pb3O4:0.003; Cu: <0.0001; Fe: 0.0008
- Lot/batch No.: 210213
- Expiration date of the lot/batch: May 2005
- Storage condition of test material: At room temperature.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation:
- Weight at study initiation: males:286-317 g: females: 192-199 g
- Fasting period before study:
- Housing: The rats were housed collectively at 3 animals per cage. Before animals arrived study room and cages were cleaned and disinfected. During study, room and cages were cleaned at regular intervals.
- Diet (e.g. ad libitum): Teklad Global 18% Rodent Diet offered ad libitum
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking water. Water subject to periodic bacteriological tests and to chemical analyses.
- Acclimation period: 23 days (females); 28 days (males)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): Air was changed about 16 times per hour and filtered adequately
- Photoperiod (hrs dark / hrs light): Artificia light was set to give a cyle of 12 hours light and 12 hours dark with light on at 7:00 AM.
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% formulation of the test article
- Amount of vehicle (if gavage):10 ml/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required): 072K0107 SIGMA
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Initially the dose of 2000 mag/kg was administered to 3 male rats. Since no mortality was observed within a few days, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females and 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were examined 1 hr, 2 hr, 6 hr and 24 h after treatment and thereafter once daily up to day 14 of the study. Body weights were recorded immediately before treatment and days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Results and discussion
- Preliminary study:
- Initially, the dose of 2000 mg/kg was administered to 3 female rats. Since no mortality was observed within a few days, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No male or female animal treated orally at the dose of 2000 mg/kg died prematurely
- Clinical signs:
- other: No clinical observations were observed in male and female animals during the 14-day observation period following the treatment at the dose of 2000 mg/kg.
- Gross pathology:
- Gross pathological examinations on day 14 p.a. (terminal necropsy) did not reveal test article-related findings.
- Other findings:
- spontaneous death n=0
killed in extremis n=0
terminal sacrifice 14 days p.appl. n=6
Animal no. Specific Findings
1-5 no specific findings
6 uterus: hydrometra
Applicant's summary and conclusion
- Interpretation of results:
- other: LD50 > 2000 mg/kg may be classified as "non-toxic" under EU (CLP) criteria. However, a conclusion cannot be made on GHS criteria.
- Conclusions:
- LD 50 >2000 mg/kg When administered by the oral route the test article may therefore be classified as "non-toxic."
- Executive summary:
The acute oral toxicity of "LITHARGE lead oxide was investigated according to ATC method in one step using 3 male and 3 female rats. Three female animals were given a single oral administration of the test article Litharge lead oxide at a dose of 2000 mg/kg. Clinical observations were carried out at regular intervals during the 14-day observation period. Body weights were determined immediately before treatment and on 7 days and 14 p.a. Gross pathological examinations were carried out immediately at termination on all animals.
The following results were obtained:
-No animals died during the course of the 14-day observation period following the dose of 2000 mg/kg.
-No abnormal clinical signs were observed
-There was no influence of the treatment on the body weight development in all male and female animals during the 14-day observation period.
-Gross pathological examinations on day 14 p.a. did not reveal test article-related findings.
According to the EEC Directive 2001/59, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p.2233), the test article LITHARGE lead oxide can be classified as "non-toxic", since the oral LD50 value after 24 h and 14 days is expected to be higher than 2000 mg/kg in male and female Wistar rats.
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