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EC number: 292-966-7 | CAS number: 91031-62-8
- 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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Endpoint summary
Administrative data
Description of key information
Reliable animal data were found indicating that lead oxide (and lead phosphite and dibasic lead phthalate) lack irritating properties for the skin or the eyes.
Sparingly soluble lead compounds do not exhibit irritant or corrosive properties in acute inhalation studies. There are no reports of respiratory irritation in occupationally exposed workers.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- skin irritation: in vivo
- 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
- Justification for type of information:
- Appropriate in vivo study was already available. No need to perform in vitro study.
- 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)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): LITHARGE lead oxide
- Physical state: fine, yellow powder
- Analytical purity: 99.8% lead (II) oxide
- Composition of test material, percentage of components: PbO: 99.8; metallic Pb: 0.01; Pb3O4:0.003; Cu: 0.001: Fe: 0.0008
- Lot/batch No.: 210213
- Expiration date of the lot/batch: May 2005
- Storage condition of test material: At room temperature - 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: - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- 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. The untreated left side of the back served as control.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- 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: - 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
- Interpretation of results:
- other: Not classified under EU (CLP) criteria. However, a conclusion cannot be made on GHS criteria.
- Conclusions:
- The test substance 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 to the skin, the test substance "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 substance 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 substance "LITHARGE lead oxide" is classified as "non-irritant."
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2002-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 type of information:
- Appropriate in vivo study was already available. No need to perform in vitro study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Litharge-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; Pb304:0.003; 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 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.67, 3.00 and 3.84 kg
- Housing: Rabbits kept individually in a battery of cages with a cage size of 100 x 45 x 40 cm equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet (pelleted diet) offerred ad libitum. Batches of diet are analysed periodically for a wide range of contaminants by Harlan Teklad
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples. Samples of drinking water are subjected periodically to bacteriological tests and to chemical analyses, including the determination of chlorinated hydrocarbons, heavy metals, and arsenic.
- Acclimation period: animals have been housed at the testing facility for 27 days or several months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 degrees C +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 16 times/hour
- Photoperiod (hrs dark / hrs light):12/12 with light on at 7:00 AM
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Remarks:
- The untreated left eye served as the control
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Three male rabbits used in the test were acclimatised to laboratory conditions for 27 days or several months. Twenty four hours before treatment, the eyes of all animals were examined for potential ocular lesions. Since the animals did not show ocular abnormalities, they were allocated to the test.The solid article was used as supplied by the Sponsor. One of the animals (rabbit no.1) was treated in advance in order to assess ocular reactions to the test article. The animal was treated with 0.1g of the solid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 second in order to limit loss of the test article. The untreated left eye served as the control. Since there was no remarkable response to the instillation of the test article within a few days, the further two animals were treated subsequently in the same manner.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Slight redness (grade 1) of the conjunctiva occurred in animal no.1 at 1 h after instillation and disappeared subsequently. No ocular findings were seen between 24 h after instillation and the end of observation 72 h after instillation. The mean grades of erythema at 24, 48 and 72 h after instillation were "0" in all animals.
- Other effects:
- No general toxic effects were observed.
- Interpretation of results:
- other: Not classified under EU (CLP) criteria. However, a conclusion cannot be made on GHS criteria.
- Conclusions:
- The test substance was classified according to the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GEfStoffV) of 15 November 1999 (BGB1, p.2233). When administered to the eye, the test substance is classified as "non-irritant."
- Executive summary:
The purpose of this study was to assess irritant and/or corrosive effects of LITHARGE lead oxide on eyes and associated mucous membranes following ocular administration to rabbits. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the eye to the test substance.
The potential toxicity of LITHARGE lead oxide was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1g of the test article was introduced into the conjunctival sac of the right eye, the untreated left eye served as control. Both eyes were examined at 1, 24, 48 and 72 hours post applicationem. The following results were obtained:
Between 24 and 72 hours after instillation no ocular findings were seen. The only finding was slight redness of the conjunctivae in one animal 1 h after instillation.
No general toxic effects were observed.
The mean grades of ocular reactions 24, 48 and 72 hours after instillation were "0" in each animal.
The test substance was classsified according to the EEC directive 2001/59/ECC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When administered to the eye, the test substance LITHARGE lead oxide may therefore be classified as "non-irritant."
Reference
Lead oxide is a non-irritant.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable animal data were found indicating that lead oxide, lead phosphite and dibasic lead phthalate lack irritating properties for the skin or the eyes. The experimental data are reinforced by a lack of reports of skin or eye irritation in the many occupational exposure environments which provide opportunities for exposure of lead and sparingly soluble lead compounds to the skin and eyes. Classification for these endpoints is clearly not needed. Specific studies of lung irritation were not found, but the lack of inhalation toxicity from lead oxide in both acute toxicity testing and inhalation cancer bioassays combine with an absence of reports of lung irritation in occupational settings to suggest classification is not needed.
The substances for which data are available should permit data waiving for a number of other substances. The three tested compounds are all sparingly soluble (and thus unlikely to undergo significant dissolution when applied to the skin, eyes or inhaled. The tested compounds further include one compound with an organic anion and one with an inorganic anion. Literature searches have failed to identify anions in other sparingly soluble substances that would alter the irritant properties of other sparingly soluble lead salts. Finally, dermal, oral and inhalation toxicity studies for lead compounds are uniformly negative and further support a finding of no irritant properties. Data waiving for all irritant classification endpoints should thus be possible for metallic lead and other sparingly soluble lead salts (unless anions are present that literature searches suggest might impart irritating properties.
No studies were found documenting corrosive properties of lead and sparingly soluble lead compounds in either experimental animals or humans. Given the negative findings of acute toxicity and irritation studies and the absence of reports from occupationally exposed workers, corrosive properties are not to be expected of lead or its sparingly soluble compounds.
Justification for selection of skin irritation / corrosion
endpoint:
Well-documented and corresponded to the requirements of the
recommended Annex V test guidelines
Justification for selection of eye irritation endpoint:
Well-documented and corresponded to the requirements of the
recommended Annex V test guidelines
Justification for classification or non-classification
No skin or eye irritation observed in experimental studies conducted according to Annex V test guidelines.
No evidence of respiratory irritation in rat acute toxicity studies up to 5mg/L and no reports of respiratory irritaion following extensive use of this substance in the workplace.
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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