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EC number: 931-722-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August-December 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. 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). On some days of the study the relative humidity was higher than 70%.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trilead dioxide phosphonate
- EC Number:
- 235-252-2
- EC Name:
- Trilead dioxide phosphonate
- Cas Number:
- 12141-20-7
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): ALLSTAB LP 3139 dibasic lead phosphite
- Molecular formula (if other than submission substance): 2PBO X PbPO3 X 0,5 H2O
- Physical state: fine white powder
- Analytical purity: 99.3%
- Composition of test material, percentage of components: 82.7% Pb; 0.2% water
- Lot/batch No.: 210510067
- Expiration date of the lot/batch: 24 months after shipping
- Storage condition of test material: At room temperature; minimum 24 months (after shipment), when stored insealed containers at temperatures below 40 degrees.
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: 2.74. 2.75 and 3.26 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 ad libitum
- Water (e.g. ad libitum): Tap water as used for human consumption was continuously available ad libitum.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals have been housed at the testing facility for 20 days or several months.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): 44-72%
- Air changes (per hr): 16 times/h and filtered adequately
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light with light on at 7:00 AM
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- The skin of the back of all animals was clipped 24 h before treatment and examined for potential lesions.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were assessed 1, 24, 48 and 72 hours after the end of the exposure.
- Number of animals:
- Three animals
- Details on study design:
- TEST SITE
- Area of exposure: Right side of the back. The untreated left side served as a control.
- % coverage:
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- very slight signs of erythema observed 1 hour after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- very slight signs of erythema observed 1 hour after patch removal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- very slight signs of erythema observed 1 hour after patch removal
- Irritant / corrosive response data:
- Very slight signs of erythema were seen 1 hour after patch removal in all three animals. Thereafter, no signs of erythma or oedema were observed. The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal.
- Other effects:
- No toxic effects with respect to the general condition were observed.
Any other information on results incl. tables
Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.
See IUCLID Section 13 for Analogue approach report.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was classified 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 criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".
- Executive summary:
The potential toxicity of "ALLSTAB LP 3139 dibasic lead phosphite" 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 the 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: -There were no skin irritating findings with the exception of very slight erythema observed 1 hour after patch removal in all three animals. -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 classified 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 criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".
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