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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 Husbandry). At some days of the study the relative humidity was higher than 70%.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): LITHARGE lead oxide
- Molecular formula (if other than submission substance):
- 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: 0.001: 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.67, 2.84 and 3.86 kg
- Housing: The rabbits were housed individually in a battery of cages with a cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet (pelleted diet, batch no. K088) offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumptiion was continuously available ad libitum via drinking nipples.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals were housed at the testing facility for 20 days or several months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): The relative humidity was kept between 44 and 72%.
- Air changes (per hr): Air was changed 16 times per hour and filtered adequately.
- Photoperiod (hrs dark / hrs light):12 hours dark/12 hours light with light on at 7:00 AM
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The skin of the back of all animals was clipped 24 hours before treatment and examined for potential lesions. Only healthy animals showing no evidence of abnormalities were allocated to the test.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left side of the back served as control.
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after exposure
- Number of animals:
- three albino rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Clipped skin on the right side of the back of rabbit
- % coverage:
- Type of wrap if used: Gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Grading of skin as stipulated by OECD 404
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after the end of the 4 hour exposure
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There were no skin irritating findings with the exception of very slight signs of erythema observed 1 hour after patch removal in all three animals.
The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal. - Other effects:
- No general toxic effects were seen
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD 404
- Conclusions:
- The test article was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure accordingto the EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied tothe skin, the test article "LITHARGE lead oxide" is classified as "non-irritant."
- Executive summary:
The potential toxicity of "LITHARGE lead oxide" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test article was applied on the right side of the dorsal clipped region, the untreated left side served as control. Exposure duration was 4 hours. Both sides were examined at 1, 24, 48, and 72 hours after the end of exposure. The following results were obtained:
-No signs of erythema and oedema were observed
-No general toxic effects were seen
-The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal.
The test article was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "LITHARGE lead oxide" is classified as "non-irritant."
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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