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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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 (Skin Sensitisation)
- 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)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to European Guideline OECD 406 Skin Sensitization a guinea pig test (GPMT or BT) must be conducted if no adverse effects were observed in corresponding prior experiments.
Test material
- 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 PbHPO3 x 0.5 H2O
- 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 white powder
- Analytical purity: 99.3%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 0210510067
- Expiration date of the lot/batch: > 24 months after shipping
- 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. Shelf Life: min. 24 months (sfter shipment), when stored in sealed containers at temperatures below 40 degrees centigrade.
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation:
- Weight at study initiation: males: 459-545 g; females: 416-530 g
- Housing: The guinea pigs were kept in collective housing up to a maximum of 5 animals per cage in a battery of cages, equipped with a paper disposal system.
- Diet (e.g. ad libitum): "2040 Teklad Global Guinea Pig Diet" (pelleted diet, batch no. K080) offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples.
- Acclimation period: 19 days (range finding); 22 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees centigrade
- Humidity (%): 37-76%
- Air changes (per hr): 16 times/ hour and filtered adequately
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light with light on at 7:00AM
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: For the intradermal injection, the test article was diluted with aqua ad iniectabilia and Freund's complete adjuvant to a final concentration of 5%. For the dermal application, the solid test article was used as 50% formulation in petrolatum.
- Concentration / amount:
- Intradermal injection- 5% of the test article
Dermal application 50% in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For the intradermal injection, the test article was diluted with aqua ad iniectabilia and Freund's complete adjuvant to a final concentration of 5%. For the dermal application, the solid test article was used as 50% formulation in petrolatum.
- Concentration / amount:
- Intradermal injection- 5% of the test article
Dermal application 50% in petrolatum
- No. of animals per dose:
- 10 test and 5 control animals
- Details on study design:
- RANGE FINDING TESTS: The range finding test was performed to determine the concentration of the test article to be used in the main test. For the intradermal injection, the test article was diluted with aqua ad iniectabilia (Delta-Pharma, Pfullingen) and Freund's complete adjuvant (FCA; batch no. 62K8933; SIGMA, Steinheim) to a final concentration of 5.0%. Two animals were employed, skin reactions being recorded 48 and 72 hours after treatment. For the dermal application, the solid test article was used 50% in petrolatum. A closed patch exposure was effected by means of an occlusive bandage using cellulose swabs, Leukosilk and non-irritating tape Elastoplast, which enveloped the whole animal's trunk. Two animals were employed and skin reactions were recorded 48 and 72 hours post applicationem.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injection sites
- Exposure period: Seven days after injection, the injection sites were covered occlusively for 48 hours.
- Test groups: 10
- Control group: 5
- Site: Clipped intracapsular region on either side of the spine.
- Frequency of applications: Three pairs of intradermal injections (0.1 ml)
- Duration: Seven days later, the previous injection sites were covered occlusively for 48 hours with a patch carrying the test article (50%) or, in control animals, the control article petrolatum.
- Concentrations: Test Group: 1) FCA 50% (v/v) diluted in aqua ad iniectabilia, 2) testt article 5% in peanut oil, 3) test article 5% in aqua ad iniectabilia/FCA. Control Group: FCA 50% (v/v) diluted in aqua ad iniectabilia, 2) peanut oil, 3) peanut oil 50% (v/v) diluted in FCA.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Both control and test animals were subjected to a challenge exposure 14 days after the second stage of the induction.
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Site: 5 x 5 cm clipped skin area on each flank
- Concentrations: The test article was applied at the concentration of 50% to the left flank and the control article petrolatum to the right in a volume of 0.5 g using the patch technique described under 6.2.1. In each case, the duration of the exposure was 24 hours under an occlusive dressing.
- Evaluation (hr after challenge): 24 and 48 hours after challenge.
OTHER: - Challenge controls:
- Both control and test animals were subjected to a challenge exposure 14 days after the second stage of the induction. The challenge test was performed on a 5 x 5 cm clipped skin area on each flank. The test article was applied at the concentration of 50% to the left flank and the control article petrolatum to the right in a volume of 0.5 g using the patch technique described under 6.2.1. In each case, the duration of the exposure was 24 hours under an occlusive dressing.
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Sensitisation rate (50%) at 24 hours: 70% Sensitisation rate (50%) at 48 hours: 70%
Sensitisation rate (25%) at 24 hours: 30% Sensitisation rate (25%) at 48 hours: 20%
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0 %
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 0 %.
Any other information on results incl. tables
There were no skin reactions after the dermal application in the induction phase. No allergic skin reactions were observed in test animals after the challenge exposure 24 and 48 hours after patch removal. No findings were observed in control animals.
The sesitisation rate, i.e. the number of animals showing an alergic response expressed as a percentage of the total number of animals, was determined 24 and 48 hours after patch removal and was 0% in test animals in each case. The corresponding reaction rate in control animals was 0%.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the EEC Directive 2001/59/EEC, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 november 1999 (BGB1. I, p. 2233), the test article "ALLSTAB LP 3139 dibasic lead phosphite" can be classified as a "non-sensitiser since no allergic responses were observed in test animals after the adjuvant test according to Magnusson & Kligman.
- Executive summary:
The potential skin sensitising properties of the test article "ALLSTAB LP 3139" were assessed in the guinea pig maximisation sensitisation test carried out as an adjuvant test according to the Magnusson & Kligman maximisation test method, using 10 test and 5 control animals in the main test. Following the induction exposure to the test article (50% in petrolatum) or the vehicle petrolatum (control article), the animals of both groups were subjected two weeks later to a challenge exposure with the test article (50% in petrolatum) as well as the control article. Responses to the challenge procedure were evaluated 24 and 48 hours after the end of the exposure period.
Results: No allergic reactions occurred in test animals 24 and 48 hours after the end of the challenge procedure. The sensitisation rate was 0%. No findings were observed in control animals (reaction rate: 0%).
Evaluation: According to nthe EEC Directive 2001/59/EEC, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p.2233), the test article "ALLSTAB LP 3139 dibasic lead phosphite" can be classified as a "non-sensitiser" since no allergic responses were observed in test animals under the experimental conditions described.
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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