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EC number: 241-047-9 | CAS number: 16970-55-1
- 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:
- 25 November 2002 to 3 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD,EU, EPA, Japan), to GLP,
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Dressings on 8 animals were removed early by mistake, test substance reapplied within 1 hr and exposure continued. Scoring of edema not written down
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Dressings on 8 animals were removed early by mistake, test substance reapplied within 1 hr and exposure continued. Scoring of edema not written down
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 2003
Test material
- Reference substance name:
- Dihydrogen tetrachloropalladate(2-)
- EC Number:
- 241-047-9
- EC Name:
- Dihydrogen tetrachloropalladate(2-)
- Cas Number:
- 16970-55-1
- Molecular formula:
- Cl4Pd.2H
- IUPAC Name:
- dihydrogen tetrachloropalladate(2-)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): dihydrogen tetrachloropalladate(II)
- Substance type: brown liquid
- Physical state: liquid
- Analytical purity: 99.95%
- Impurities (identity and concentrations): 0.05%
- Composition of test material, percentage of components: 47% by weight of dihydrogen tetrachloropalladate(II) in solution
- Purity test date: no data
- Lot/batch No.: 4515932529
- Expiration date of the lot/batch: 12 September 2003
- Stability under test conditions: at least 96 hr (in water)
- Storage condition of test material: room temperature, in dark
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
Kisslegg
Germany
- Age at study initiation: about 4 weeks
- Weight at study initiation: 361-393 g
- Housing: caged on purified sawdust
- 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): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.05% and 0.1% for injection and 5% epidermal application (induction)
5% for epidermal application (challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.05% and 0.1% for injection and 5% epidermal application (induction)
5% for epidermal application (challenge)
- No. of animals per dose:
- 10 (test substance)
5 (controls) - Details on study design:
- RANGE FINDING TESTS:
a) one animal each injected with either 0.1 and 0.2%, or 0.02 and 0.5%, or 0.5 and 1%, or 2 and 5%. Examined 24 and 48 hr later
b) two animals each dosed topically with either 0.5 and 1%, or 2 and 5%, or 10 and 20%. Assessed at 24 and 48 hr
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal followed by topical application to the injection site one week later. Three pairs of simultaneous injections were given as follows: Freunds complete adjuvant; 0.05% test substance; 0.1% test substance emulsified in the adjuvant.
- Exposure period: 48 hr
- Test groups: 1 test and 1 control group
- Control group: treated in same way but without the test substance
- Site: scapular region, each side of the midline
- Frequency of applications: once
- Duration: 21 days
- Concentrations: 0.05% and 0.1% for injection and 5% epidermal application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hr
- Test groups: 1 test and 1 control group
- Control group: treated in same way
- Site: flank
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hr after removal of the dressing
OTHER: - Challenge controls:
- 5%
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- body weight gains normal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 9.0. Clinical observations: body weight gains normal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- body weight gains normal
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 9.0. Clinical observations: body weight gains normal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
Brown/orange staining was observed at the treated sites after challange, but this evidently did not hamper scoring of the reactions.
One animal died on the day of first induction treatment. No further mortality was reported and no systemic toxicity was observed in the surviving animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Dihydrogen tetrachloropalladate(II) induced skin sensitisation in a OECD guideline GPMT, in which a group of ten guinea pigs were dermally challenged with 5% of the test compound following a two stage induction with 0.05% by intradermal injection and 5% applied topically.
- Executive summary:
The ability of dihydrogen tetrachloropalladate to induce contact sensitisation was assessed in a OECD Test Guideline 406 guinea pig maximisation test (GPMT), conducted to GLP, using groups of 10 test and 5 control animals.
Animals were induced with 0.05% by intradermal injection, followed one week later by a second induction by topical application of 5% of the test substance under a 48-hr occlusive patch. Control animals were similarly treated but without the test substance. A challenge dose of 5% was applied under an occlusive patch for 24 hr three weeks after topical induction to both test and control animals. These doses were selected after a preliminary range-finding study.
Positive reactions were seen in 3 of the 9 animals exposed to the test substance after exposure to the challenge dose. One animal died on the day of first induction from abdominal bleeding. No reactions were observed in the control animals when examined at 24 and 48 hr after exposure to the challenge dose. No systemic toxicity was evident.
Overall, dihydrogen tetrachloropalladate induced skin sensitisation in 3 of 9 animals in the GPMT, thus requires classification as a skin sensitiser according to EU CLP criteria (EC 1272/2008).
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