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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The single dermal application and the pre- and post- observation periods were between 06 April and 28 April 1989.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A OECD guideline study, to GLP. However, the data did not permit the calculation of a primary dermal irritation index; the degree of erythema could not be assessed due to discolouration of the skin by the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 003
- Cas Number:
- 16919-73-6
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): potassium hexachloropalladate (IV)
- Substance type: red powder
- Physical state: solid
- Analytical purity: 26.8% Pd
- Impurities (identity and concentrations): no data
- Purity test date: Apparently 07 July 1989
- Lot/batch No.: 041368
- Expiration date of the lot/batch: no data
- Stability under test conditions: Stable
- Storage condition of test material: kept desiccated in a closed container in a fridge
- Other: “substance archives no.”: 87786
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 6 months (single male); 7 or 10 months ( two females)
- Weight at study initiation: 2.55 kg (single male); 2.50 or 2.55 kg (two females)
- Housing: Stainless steel ASTA cages with grating floor, size 48.5(L)x40(B)x36.5(H) cm
- Diet (e.g. ad libitum): Approximately 120 g/animal/day of standard diet ssniff K “Special Diet for Rabbits”, supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): ad libitum from Stadtwerke Beilefeld (Municipal Works)
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-24
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6 am- 6 pm: artificial lighting; 6 pm-6 am: “natural light-dark-rhythm”)
IN-LIFE DATES: From: To: no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Backs of the rabbits were clipped one day before treatment.
- Vehicle:
- water
- Remarks:
- [demineralized; to moisten test material only]
- Controls:
- other: a comparable area of skin treated identically but without test substance served as concurrent control.
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.14 ml- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- One male and two females
- Details on study design:
- TEST SITE
- Area of exposure: linen cloth covering application site was approximately 6.25 cm2
- Type of wrap if used: Acrylastic bandage, No. 2408, width 8 cm, supplied by P. Beiersdorf and Co. AG, Hamburg. This was placed over a linen cloth fixed with “a synthetic film glue” that covered the application site.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes – performed gently
- Time after start of exposure: 4 hours
SCORING SYSTEM: Oedema was evaluated qualitatively and quantitatively, according to the Draize method (see below, in “Any other information ...” section), at 1, 24, 48 and 72 hours after removal of the occlusive covering. Neither qualitative nor quantitative evaluation of erythema (and eschar formation) were possible because the test substance caused yellow-orange discolouration of the exposed skin area.
[Normally, erythema (and eschar formation) and oedema values for each animal and each time-point would be added. An “irritation index” would then be calculated by dividing by this value by the number of observations (in this case the number of observations would equal 12, the product of “4 time-points x 3 animals”). The study report notes that irritation indices of: up to 0.5 would indicate a non-irritant; 0.6-3.0 would indicate a slight irritant; 3.1-5.0 would indicate a moderate irritant; 5.1-8.0 would indicate a severe irritant].
Animals were assessed daily for the 10-day observation period for other skin reactions (such as corrosion) and clinical symptoms.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks on result:
- other: [It was not possible to assess the degree of redness (erythema) resulting from exposure due to discolouration of the skin by the test substance]
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after termination of exposure
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The maximum oedema score was seen in a single animal 24 hours post-application.
- Irritant / corrosive response data:
- Oedema was seen in all animals. It was very slight in two (in one, upon removal of the occlusive covering and persisting until day 6 of observation; in the other, at 24- and 48-hours post-exposure only). In the third animal, moderate oedema was seen at 24-hours post-exposure; this gradually reduced in severity until no oedema was apparent on day 7 of observation.
It was reported that a slight or moderate oedema [see Remarks, below] was seen beyond the boundary of the exposure site at one- and two-days post-exposure in a single animal [it was not clear which animal].
In two animals, skin scales formed but apparently peeled off “immediately” [presumably upon removal of the occlusive bandage].
The effects were considered by the authors to be of “only slight to moderate intensity”. - Other effects:
- No systemic toxic effects were seen.
Any other information on results incl. tables
In their summary, the authors note that “slight erythema” beyond the area of exposure was seen in one animal. The authors' summary also reports “very slight or moderate to severe” oedema, but neither the results section nor the data table [Table 1, attached] report severe oedema in any of the animals at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD Guideline study, to GLP, the irritant effect of dipotassium hexachloropalladate to the skin of rabbits was described as of “only slight to moderate intensity”. It was not possible to assess the degree of redness (erythema) resulting from exposure due to discolouration of the skin by the test substance, but the oedema score indicates that this is probably a reasonable conclusion.
- Executive summary:
In a GLP skin irritation study in rabbits,conducted according to OECD Test Guideline 404, dipotassium hexachloropalladate (0.5 g, moistened) was applied (occluded) to the clipped but intact skin of one male and two female rabbits. After 4 hours, the dressings were removed and the skin sites gently washed. Each site was quantitatively assessed for oedema at 1, 24, 48 and 72 hours (and subsequently once/day up to 10 days post-application). Erythema and eschar formation could not be assessed quantitatively or qualitatively because the test material caused yellow or orange discolouration of the application site. Consequently the calculation of a primary irritation index was not possible.
The authors concluded that the irritant effects of this material were of “only slight to moderate intensity”.
Due to the skin site discolouration, it is not possible to give a definitive classification interpretation according to EU CLP criteria. However, it is considered precautionary to classify the test material as a skin irritant (Category 2), according to CLP criteria (EC 1272/2008).
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