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EC number: 237-489-7 | CAS number: 13815-17-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-16 June 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 2000
Test material
- Reference substance name:
- Tetraamminepalladium dichloride
- IUPAC Name:
- Tetraamminepalladium dichloride
- Reference substance name:
- Tetraamminepalladium(2+) dichloride
- EC Number:
- 237-489-7
- EC Name:
- Tetraamminepalladium(2+) dichloride
- Cas Number:
- 13815-17-3
- Molecular formula:
- H8Cl2N4Pd
- IUPAC Name:
- tetraaminopalladiumbis(ylium) dichloride
- Details on test material:
- - Name of test material (as cited in study report): tetra ammine palladium chloride
- Substance type: pale yellow crystalline solid
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: DK0164
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in dark
- Other:
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited
Burton-on-Trent
Staffordshire
UK
- Age at study initiation:
- Weight at study initiation: 347-421 g
- Housing: solid-floor polypropylene cages; bedding - woodchips
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.01% in distilled water - injection
10% in distilled water - topical induction
1% and 2% in distilled water - topical challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.01% in distilled water - injection
10% in distilled water - topical induction
1% and 2% in distilled water - topical challenge
- No. of animals per dose:
- 10 (5 animals in control group)
- Details on study design:
- RANGE FINDING TESTS:
Intradermal induction: one animal each treated with 0.01, 0.05, 0.1, 0.5, 1.0 or 5% and examined for erythema at 24, 48 and 72 hr and at 7 days
Topical induction: Two guinea pigs (injected with Freund’s complete adjuvant 14 days earlier) each received applications of 5, 10, 25 and 50% of the test material under an occlusive dressing. Examined for erythema and odema at 1, 24 and 48 hr.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One injection, followed 7 days later by topical application
- Exposure period: topical – 48 hr
- Test groups: Injection – three injections in shoulder region on each side of the mid-line as follows:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) 0.01% w/w formulation of the test material in distilled water
c) 0.01% w/w formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
- Control group: as above, but without the test material
- Site: shoulder region, on each side of the mid-line
- Frequency of applications: once
- Duration: topical – 48 hr
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after the topical induction
- Exposure period: 24 hr
- Test groups:
- Control group: treated with test substance as test group
- Site: flank
- Concentrations: 1% to left flank, 2% to right flank
- Evaluation (hr after challenge): 24 and 48 hr - Challenge controls:
- Treated as for test group
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive controls included in this study. A table giving historical positive control data for 2-mercaptobenzothiazole is included in the study report, showing between a 70-100% incidence of sensitisation in groups of ten female guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No evidence of adverse effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: No evidence of adverse effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No evidence of adverse effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: No evidence of adverse effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- One animal was found dead on day 14 from causes not related to the test material. No other clinical signs were evident.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 and 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: One animal was found dead on day 14 from causes not related to the test material. No other clinical signs were evident..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 and 2%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- One animal was found dead on day 14 from causes not related to the test material. No other clinical signs were evident.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 and 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: One animal was found dead on day 14 from causes not related to the test material. No other clinical signs were evident..
Any other information on results incl. tables
In test group with 2% challenge dose, at 48 hr 6 animals showed erythema (grades 1 and 2) and one animal had odema (at 24 hr the totals were 9 and 4, respectively for erythema and odema. Reactions that had disappeared by 48 hr were not attributed to sensitisation).
In test group with 1% challenge dose, at 48 hr 5 animals showed erythema (grade 1) and one animal had odema (at 24 hr the totals were 9 and 1, respectively for erythema and odema. Reactions that had disappeared by 48 hr were not attributed to sensitisation).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- In an in vivo guinea pig maximisation test (GPMT), conducted to GLP and according to OECD Test Guideline 406, tetraamminepalladium dichloride exhibited moderate skin sensitising potential
- Executive summary:
Tetraammine palladium chloride was assessed for its contact sensitising potential in a guinea pig maximisation test (GPMT) conducted according to OECD Test Guideline 406, and to GLP.
A group of ten male animals were induced by intradermal injection of 0.1% of the test material (in distilled water), with and without Freund's Complete Adjuvant, followed 7 days later by topical exposure to 10% (in distilled water) under an occluded patch. Challenge doses of 1 and 2% (in distilled water) were applied to different sites 14 days later and the areas examined at 24 and 48 hr for erythema and oedema. A further group of five males were used as controls, receiving the same induction procedure but without the test substance, and challenged similarly to the treatment group.
Six of the ten treated animals showed evidence of sensitisation at 48 hr (erythema, grade 1 or 2); three further animals exhibited erythema at 24 hr but not at 48 hr and these reactions were therefore considered not to be due to sensitisation. Tetraamminepalladium chloride exhibited moderate skin sensitising potential in this study.
According to EU CLP criteria (EC 1272/2008), tetraamminepalladium chloride should be classifed as a skin sensitiser (category 1A).
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