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EC number: 240-974-6 | CAS number: 16919-73-6
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8-14 May 2013 (preliminary experiment was 12-17 December 2012)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- temperature reached 26.2°C (i.e. >25°C) on one occasion. Deviation not considered to impact on validity of study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reference substance 003
- Cas Number:
- 16919-73-6
- Test material form:
- other: solution
- Details on test material:
- - Name of test material (as cited in study report): diammonium hexachloropalladate
- Substance type: no data
- Physical state: brown-red powder
- Analytical purity: ~100%
- Impurities (identity and concentrations) (ppm wirth respect to metal): aluminium (3), gold (3), calcium (7), iron (2), potassium (43), sodium (56), platinum (34), rhodium (2), silicon (53), titanium (4)
- Composition of test material, percentage of components: palladium at 29.86%
- Isomers composition: no data
- Purity test date: 7 September 2004
- Lot/batch No.: DP0367
- Expiration date of the lot/batch: 30 September 2024
- Stability under test conditions: stable in propylene glycol for at least 2 hours
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Route de Chènes Secs B.P. 4105, 53940 Le Genest-St-Isle, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 19.7-21.8 g
- Housing: individual caging (polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (a maximum of 26.2 was recorded on 30 April 2013)
- Humidity (%): 30-70
- Air changes (per hr):15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- Range-finding study: 25 or 50% (w/v)
Main study: 0, 10, 25 or 50% (w/v) - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: short preliminary compatibility test performed in which solubility was assessed in acetone:olive oil (4:1), N,N-dimethylformamide, methyl ethyl ketone, propylene glycol, dimethyl sulfoxide and 1% Pluronic. Propylene glycol gave the highest concentration which was suitable for dosing (50%).
- Irritation: groups of mice (2/dose) were treated topically with 25 or 50% test substance. Mice were observed daily for signs of local irritation, changes in ear thickness, and systemic toxicity up until day 6. No adverse effects were observed.
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: the test item is regarded as a sensitiser if both of the following criteria are fulfilled:
1. That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
2. The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: groups of mice were given topical applications to the ear of 25 µl of formulation om three consecutive days (1, 2 and 3). On day 6, animals were injected with tritiated thymidine (3HTdR) and killed 5 hours later. Lymph node cell proliferation was then assessed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- As expected. See Table 1 in "Any other information on results incl. tables".
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 10.6, 14.9 and 1.3 at concentrations of 50, 25 and 10 % (w/v), respectively. Also see Table 1 in "Any other information on results incl. tables".
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 1 in "Any other information on results incl. tables".
Any other information on results incl. tables
No adverse effects on body weight were observed.
The calculated EC3 value is 11.9% (w/v).
Table 1. Results of a mouse local lymph node assay on diammonium hexachloropalladate
Test Group Name |
Measured DPM |
DPM |
Number of lymph nodes |
DPN |
Group DPN |
Stimulation Index |
Background (5% trichloroacetic acid) |
42 35 |
- |
- |
- |
- |
- |
Propylene glycol |
227 |
188.5 |
2 |
94.3 |
38.4 |
1.0 |
104 |
65.5 |
32.8 |
||||
106 |
67.5 |
33.8 |
||||
80 |
41.5 |
20.8 |
||||
59 |
20.5 |
10.3 |
||||
50% DAHP |
884 |
845.5 |
2 |
422.8 |
405.0 |
10.6 |
474 |
435.5 |
217.8 |
||||
1179 |
1140.5 |
570.3 |
||||
645 |
606.5 |
303.3 |
||||
1060 |
1021.5 |
510.8 |
||||
25% DAHP |
133 |
94.5 |
2 |
47.3 |
571.5 |
14.9 |
2516 |
2477.5 |
1238.8 |
||||
2740 |
2701.5 |
1350.8 |
||||
223 |
184.5 |
92.3 |
||||
295 |
256.5 |
128.3 |
||||
10% DAHP |
66 |
27.5 |
2 |
13.8 |
51.2 |
1.3 |
121 |
82.5 |
41.3 |
||||
325 |
286.5 |
143.3 |
||||
93 |
54.5 |
27.3 |
||||
99 |
60.5 |
30.3 |
||||
25% HCA |
1137 |
1098.5 |
2 |
549.3 |
808.2 |
21.1 |
1855 |
1816.5 |
908.3 |
||||
1186 |
1147.5 |
573.8 |
||||
2840 |
2801.5 |
1400.8 |
||||
1256 |
1217.5 |
608.8 |
||||
Notes: 1. DPM (Disintegrations Per Minute) 2. DPN (Disintegrations Per Node) = DPM divided by the number of lymph nodes. 3. DAHP (Diammonium hexachloropalladate) 4. HCA (α-Hexylcinnamicaldehyde) 5. Stimulation Index = mean DPN of a treated group divided by mean DPN of the appropriate control group. |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP mouse LLNA, performed according to OECD Test Guideline 429, significant evidence (a calculated EC3 value of 11.9%) for the skin sensitising potential of diammonium hexachloropalladate was reported.
- Executive summary:
The skin sensitising potential of diammonium hexachloropalladate has been assessed in a GLP mouse local lymph node assay (LLNA), performed according to OECD Test Guideline 429. Following a preliminary range-finding study to assess irritancy, female mice (5/group) were treated topically with 0, 10, 25 or 50% diammonium hexachloropalladate (in propylene glycol) on three consecutive days (1, 2 and 3). On day 6, cell proliferation in the local lymph nodes was measured by incorporation of injected tritiated methyl thymidine (3HTdR). No mortality or clinical signs of toxicity were observed, and there were no signs of local irritation at the application site. Observed stimulation index values were 10.6, 14.9 and 1.3 at 50, 25 and 10%, respectively. The calculated EC3 value (the concentration producing a stimulation index of 3) was 11.9%. Positive and vehicle controls performed as expected.
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