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EC number: 231-596-2 | CAS number: 7647-10-1
- 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
Endpoint summary
Administrative data
Description of key information
In a guideline study, to GLP, palladium dichloride applied to the clipped skin of three rabbits (4-hr semi-occluded) produced a primary irritation index of 3 and was considered as a moderate irritant according to the Draize classification system. No corrosive effects were noted (Allen, 1994b). However, as the test material produced “positive criteria” in only 1 of 3 rabbits according to the EU CLP criteria (i.e. a mean grade of >2.3 at the 24, 48 and 72 hr times for oedema in one animal only), classification as a skin irritant is not required.
According to an expert review of an
early unpublished eye irritation study, conducted to US guidelines (CFR
21, part 191 12), a single instillation of palladium dichloride (100 mg)
to the eyes of six rabbits produced irreversible effects (Hysell et al.,
1974).
No relevant respiratory tract data were
identified.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 February to 28 February 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD), to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No untreated (control) areas; no evidence that systemic adverse effects were recorded.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No untreated (control) areas; no evidence that systemic adverse effects were recorded.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 49-56
- Air changes (per hr): 15 changes
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- 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): 0.5 ml - Duration of treatment / exposure:
- Single 4 hour exposure
- Observation period:
- 7 days
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage:
- Type of wrap if used: The patch was secured with a strip of surgical adhesive tape (2.5 cm x 4 cm), and the trunk of each rabbit wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water followed by diethyl ether
- Time after start of exposure: 4 hr
SCORING SYSTEM: The treated skin area was qualitatively and quantitatively scored using the Draize method at 1, 24, 48, and 72 hrs following removal of the patches (see OECD guidelines for grading of skin reactions). The primary irritation index is given by the sum of the values for erythema and oedema at the 24 and 72-hr readings and divided by 6.
Primary irritation index Classification
0 non-irritant
>0-2 mild irritant
>2-5 moderate irritant
>5-8 severe irritant
In addition, attention was paid to the occurrence of other skin reactions and irreversible alteration of the dermal tissue (which would lead to a classification of corrosive effects); systemic toxic effects were evidently not assessed. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hrs
- Score:
- ca. 3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days (for erythema/ oedema), although crust formation and desquamation seen on day 7
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr
- Score:
- 3.2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days (for erythema/ oedema), although crust formation and desquamation seen on day 7
- Irritant / corrosive response data:
- Very slight to well-defined erythema was noted in all three rabbits assessed at 1, 24, 48 and 72 hr after patch removal. Very slight (1 animal) to slight oedema (2 animals) was noted 1 hour after patch removal, with very slight to moderate oedema at the 24- and 48-hr observations. Very slight (1 animal), slight (1 animal), or no oedema (1 animal) was seen at the 72-hr observation.
Skin reactions noted in all three rabbits 7 days after treatment were crust formation and desquamation. No corrosive effects were noted. - Other effects:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guideline study, to GLP, palladium dichloride applied to the clipped skin of three rabbits (4-hr semi-occluded) produced a primary irritation index of 3 and was considered as a moderate irritant according to the Draize classification system. No corrosive effects were noted. However, as the test material produced “positive criteria” in only 1 of 3 rabbits according to the EU CLP criteria (i.e. a mean grade of >2.3 at the 24, 48 and 72 hr time for oedema in one animal only), classification as a skin irritant is not required.
- Executive summary:
Palladium dichloride was investigated for irritant (and corrosive) effects following 4-hr (semi-occluded) application (0.5 g), moistened with 0.5 ml distilled water, to the clipped skin of three New Zealand white rabbits (one male and two females) in accordance with OECD Test Guideline 404 (with slight deviations), and to GLP. Following removal of the patch (and residual test material), the sites were observed for signs of erythema and oedema at 1, 24, 48 and 72 hrs using the Draize grading scores. The test site was again assessed at day 7; no untreated site (as recommended by the OECD) was apparently assessed.
Very slight to well-defined erythema and very slight to moderate oedema were seen. Crust formation or desquamation were observed on all three animals 7 days after treatment. The test material produced a primary irritation index of 3 (from the mean of the 24- and 72 -readings) and was considered as a moderate irritant according to the Draize classification system. No corrosive effects were noted.
However, as the test material produced “positive criteria” in only 1 of 3 rabbits according to the EU CLP criteria (i.e. a mean grade of >2.3 at the 24-, 48- and 72-hr time for oedema in one animal only), classification as a skin irritant is not required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (US CFR), pre-GLP, with limited reporting.
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 21, part 191 12 (revised as of April 1, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- (prior to GLP)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Albino rabbits with no known ocular abnormalities.
- Vehicle:
- not specified
- Controls:
- other: The left eye of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (deposited on the eye surface) - Duration of treatment / exposure:
- Presumably the observation period
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Not removed
SCORING SYSTEM: No data
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- other: Number of animals showing irritant reactions
- Basis:
- other: Total number of test animals
- Time point:
- other: 24 hours
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- not reversible
- Irritation parameter:
- other: Number of animals showing irritant reactions
- Basis:
- other: Total number of test animals
- Time point:
- other: 48 hours
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- not reversible
- Irritation parameter:
- other: Number of animals showing irritant reactions
- Basis:
- other: Total number of test animals
- Time point:
- other: 72 hours
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- All six animals receiving palladium dichloride showed corrosive conjunctival lesions and severe inflammation of the cornea and anterior chamber of the eye.
- Other effects:
- No data
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to an expert review of an early unpublished eye irritation study, conducted to US guidelines (CFR 21, part 191 12), a single instillation of palladium dichloride (100 mg) to the eyes of six rabbits produced irreversible effects.
- Executive summary:
According to an expert review of an early unpublished eye irritation study, conducted to US test guidelines (CFR 21, part 191 12), palladium dichloride (100 mg) was instilled into one eye of each of six rabbits. The other eye remained untreated and acted as the control. The treated eye was then assessed for ocular inflammation 24, 48 and 72 hr after application. All six animals showed severe conjunctival lesions and severe inflammation of the cornea and anterior chamber of the eye. The effects persisted throughout the observation period indicating that the test material induced irreversible effects on the eye.
Based on the results of this study, palladium dichloride should be classified as Category 1 (irreversible effects on the eye) according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant human irritation/corrosion data were identified. No in vitro skin or eye irritation studies were identified, or are required, as reliable in vivo studies are already available.
In a guideline study, to GLP, palladium dichloride applied to the clipped skin of three rabbits (4-hr semi-occluded) produced a primary irritation index of 3 and was considered as a moderate irritant according to the Draize classification system. No corrosive effects were noted (Allen, 1994b). However, as the test material produced “positive criteria” in only 1 of 3 rabbits according to the EU CLP criteria (i.e. a mean grade of >2.3 at the 24, 48 and 72 hr times for oedema in one animal only), classification as a skin irritant is not required.
In support, palladium dichloride was not irritant in a limited (pre-GLP) study, involving 24-hr occluded application to the intact skin of 6 male rabbits. To abraded skin, it caused at most only a mild irritant reaction (Campbell et al., 1975).
According to an expert review of an early unpublished eye irritation study, conducted to US test guidelines (CFR 21, part 191 12), palladium dichloride (100 mg) was instilled into one eye of each of six rabbits. The other eye remained untreated and acted as the control. The treated eye was then assessed for ocular inflammation 24, 48 and 72 hr after application. All six animals showed severe conjunctival lesions and severe inflammation of the cornea and anterior chamber of the eye. The effects persisted throughout the observation period indicating that the test material induced irreversible effects on the eye. Based on the results of this study, palladium dichloride should be classified for eye damage as Category 1 (irreversible effects on the eye) according to EU CLP criteria (EC 1272/2008).
No respiratory tract data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement. Further, the compound is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure.
Justification for selection of skin
irritation / corrosion endpoint:
OECD guideline study, to GLP.
Justification for selection of eye irritation endpoint:
US Guideline study and the only eye irritation study available.
Justification for classification or non-classification
Based on the results of the available in vivo skin and eye irritation studies, palladium dichloride should not be classified as irritant/corrosive to the skin, but should be classified for ‘irreversible effects on the eye’ (category 1), according to EU CLP criteria (EC 1272/2008).
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