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Diss Factsheets
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EC number: 235-038-9 | CAS number: 12060-00-3
- 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
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- August 2003-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.
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 husbandry). On some of the study days, the relative humidity was higher than 70%.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- Lead monoxide
- EC Number:
- 215-267-0
- EC Name:
- Lead monoxide
- Cas Number:
- 1317-36-8
- Details on test material:
- - Name of test material (as cited in study report): Litharge lead oxide
- Molecular formula (if other than submission substance): PbO
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: fine, yellow powder
- Analytical purity: 99.8% lead (II) oxide
- Impurities (identity and concentrations):
- Composition of test material, percentage of components: PbO: 99.8; metallic Pb: <0.01; Pb3O4: 0.003; Cu:<0.0001; Fe: 0.0008.
- Isomers composition:
- Purity test date:
- Lot/batch No.: 210213
- Expiration date of the lot/batch: May 2005
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: at room temperature
- Other:
Constituent 1
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
- Weight at study initiation: male 285-323 g; female: 187-218 g
- Housing:Before the animals arrived, the study room and cages were cleaned and disinfected. During the study, the room and cages were cleaned at regular intervals. The rats were hpoused individually in cages (Makrolon II).
- Diet (e.g. ad libitum): Teklad Global 18% Protein Rodent Diet (pelleted diet, batch no.204986) offered ad libitim.
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking bottles. Samples of drinking water are subjected to bacteriological tests, including the determination of chlorinated hydrocarbons, heavy metals and arsenic.
- Acclimation period: range finding: 15 days; main test: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was adjusted to 22 +/-3
- Humidity (%): The relative humidity was kept between 38 and 78%. Maximum and minimum temperature and humidity were monitored daily.
- Air changes (per hr): Air was changed about 16 times per hour and filtered adequately.
- Photoperiod (hrs dark / hrs light): Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7:00 AM.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: One day before each treatment, the fur was clipped from a dosal area of approx. 5X10 cm in each animal. The skin was subsequently examined for abrasions. Since the skin was healthy and intact, all animals were used for the test and coloured for individual identification.
- % coverage:
- Type of wrap if used: An occlusive dressing using a 4X5 cm patch (filter paper), Leukosilk and Elastoplast. To ensure good contact of the test article with the skin, a few drops of peanut oil were placed on the patch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patch Removal
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): The test article was used undiluted as supplied by the Sponsor
- Constant volume or concentration used: yes/no
- For solids, paste formed: No.
VEHICLE
- Amount(s) applied (volume or weight with unit): The solid test article was used undiluted as supplied by the Sponsor.
- Concentration (if solution):
- Lot/batch no. (if required): 210213
- Purity: 99.8% PbO
- Duration of exposure:
- The exposure period was 24 hours
- Doses:
- The rats were given a single dermal administration of the test artcle of 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- In each animal a number of clinical-toxicological signs were evaluated according to a modified IRWIN Screening procedure (S. Irwin; Comprehensive Observational Assessment, Psychopharmacologia 134, 222-257, 1968) and observed findings were recorded. The animals were examined until 10min. p.a. and at the following post-treatment intervals: 1h, 2h, 6h, 24h and thereafter once daily up to day 14. Because of the occlusive dressing, the evaluation of some parameters were excluded until the 24-h observation time point. After patch removal, dermal irritation was evaluated once daily for14 days according to a scheme based on Draize. Body weights were recorded immediately before treatment and on days 7 and 14 p.a. (termination).
Results and discussion
- Preliminary study:
- The range finding test was conducted using 2 female animals which were treat
ed with the dose of 2000 mg.kg body weight. There were no deaths in the preliminary study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No animal died during the course of the main test after the single dermal administration of 2000 mg/kg.
- Clinical signs:
- other: No abnormal clinical signs were observed. No skin irritation findings were seen.
- Gross pathology:
- Gross pathological examinations at day 14 p.a. (terminal necropsy) revealed no findings.
- Other findings:
- No specific findings.
Any other information on results incl. tables
On the basis of the results obtained after a single dermal administration of the test article "LITHARGE lead oxide" to Wistar rats, the LD50 values after 24 h and 14 days were as follows: Male and female > 2000 mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information LD50 > 2000 mg/kg may be classified "non-toxic." Criteria used for interpretation of results: other: Draize
- Conclusions:
- No specific findings. On the basis of the results, obtained after a single dermal administration of the test article "LITHARGE lead oxide" to Wistar rats, the LD50 values after 24 h and 14 days were as follows: Male and Female > 2000 mg/kg. This value is higher than the limit specified as harmful by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1.I, p. 2233). When administered by the dermal route, the test article "Litharge lead oxide" may be classified as "non-toxic".
- Executive summary:
The acute dermal toxicity of LITHARGE lead oxide was investigated in one group of rats comprising 5 males and 5 females. On the basis of the range finding test, the animals were given a single dermal administration of LITHARGE lead oxide at the dose of 2000 mg/kg. The skin was exposed to the test articles for 24 hours. Clinical observations were carried out at regular intervals during the 14 -day observation period. Signs of erythema and oedema were evaluated once daily for 14 days. Body weights were determoned immediately before treatment and on days 7 and 14 p.a. Gross pathological examinations were carried out at study termination on all animals. The following results were obtained:
- No animal died during the 14 -day observation period.
- No abnormal clinical signs were observed.
- No signs of or skin iiritation were observed.
- The body weight development was slightly influenced in most animals during the first week after treatment, possibly due to the administration procedure as such. At the end of the study, 14 days after treatment, the body weights were in the normal range
-Gross pathological examinations on day 14 p.a. did not reveal any findings in the rats.
Since no deaths were caused in Wistar rats after dermal treatment with the test article LITHARGE lead oxide of 2000mg/kg, the LD50 values after 24h and 14 days were as follows: Male and Female >2000 mg/kg
The above value is higher than the limit specified as harmful by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahstoffverordnung (GedStoffV) of 15 November 1999 (BGB1.I, p. 2233). When administered by the dermal route, the test article LITHARGE lead oxide may therefore be classified as "non-toxic".
These results can be assigned to lead titanium trioxide since a read across based on a grouping of substances (Pb substances) is applied.
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.
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