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Diss Factsheets
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EC number: 266-047-6 | CAS number: 65997-18-4 Frit is a mixture of inorganic chemical substances produced by rapidly quenching a molten, complex combination of materials, confining the chemical substances thus manufactured as nonmigratory components of glassy solid flakes or granules. This category includes all of the chemical substances specified below when they are intentionally manufactured in the production of frit. The primary members of this category are oxides of some or all of the elements listed below. Fluorides of these elements may also be included in combination with these primary substances.@Aluminum@Manganese@Antimony@Molybdenum@Arsenic@Neodymium@Barium@Nickel@Bismuth@Niobium@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Cerium@Silver@Chromium@Sodium@Cobalt@Strontium@Copper@Tin@Gold@Titanium@Iron@Tungsten@Lanthanum@Vanadium@Lead@Zinc@Lithium@Zirconium@Magnesium
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- 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.
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.
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