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EC number: 238-269-3 | CAS number: 14323-43-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-15 August 2012
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: Acute dermal toxicity study: limit test
- Limit test:
- yes
Test material
- Reference substance name:
- Diamminedichloropalladium
- EC Number:
- 238-269-3
- EC Name:
- Diamminedichloropalladium
- Cas Number:
- 14323-43-4
- Molecular formula:
- Cl2H6N2Pd
- IUPAC Name:
- Diamminedichloropalladium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Diamminedichloropalladium
- Substance type: Technical product
- Physical state: Solid (yellow powder)
- Analytical purity: >99.5% (Palladium content 50.33%)
- Impurities (identity and concentrations): A certificate of analysis, detailing levels of metals (some present in trace amounts), constitutes Appendix 4 of the study report
- Composition of test material, percentage of components: A certificate of analysis, detailing levels of metals (some present in trace amounts), constitutes Appendix 4 of the study report
- Purity test date: 14 December 2011
- Lot/batch No.: 11011
- Expiration date of the lot/batch: 31 October 2012
- Stability under test conditions: No data
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI) rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Hygienic level at arrival: SPF
- Age at study initiation: Not reported
- Weight at study initiation: Between 222 g and 247 g
- Fasting period before study: None
- Housing: "Standard housing conditions": Individual caging; Type II. polypropylene/polycarbonate cage; Laboratory bedding:
Lignocel(R) Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH&Co.KG
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany ad libitum,
- Water (e.g. ad libitum): tap water from the municipal supply, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- But "Sufficient water to damp the material was used to ensure good contact with the skin."
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the back
- % coverage: approximately 10 % area of the total body surface
- Type of wrap if used: sterile gauze, held in place with a patch of adhesive hypoallergenic plaster, wrapped with semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water at body temperature
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Paste formed: presumably yes - "Sufficient water to damp the material was used to ensure good contact with the skin." - Duration of exposure:
- 24 hours (occlusive contact)
- Doses:
- 2000 mg/kg bw only
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: on the day of treatment at 1 and 5 hours after application of the test item, and once each day thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Frequency of weighing: The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14.
- Necropsy of survivors performed: yes. Macroscopic examination was performed on all animals. All surviving animals were anaesthetised with Euthasol®40% and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded. - Statistics:
- None reported.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL not applicable
- Mortality:
- None
- Clinical signs:
- other: No adverse clinical signs were observed after the treatment with the test item or during the 14-day observation period.
- Gross pathology:
- There were no macroscopic abnormalities in any animals
- Other findings:
- No signs of dermal irritation were observed following patch removal or during the 14 day observation period.
Any other information on results incl. tables
There were no control animals; the benchmark by which there was considered to be no effect on body weights is not clear from the study report.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD Test Guideline 402 study, to GLP, there were no deaths over a 2-week observation period following application of neat diamminedichloropalladium for 24 hours under occlusion at a limit dose of 2000 mg/kg bw to the skin of groups of 5 male and 5 female rats.
- Executive summary:
In an acute toxicity test by the dermal route, conducted according to OECD Test Guideline 402 and to GLP, groups of 5 male and 5 female rats were dermally exposed to neat diamminedichloropalladium for 24 hours (under occlusion).
There were no deaths, clinical signs, gross pathological effects or indications of skin irritation in any of the animals over a 2 -week post-dose observation period. The acute dermal median lethal dose (LD50) of diamminedichloropalladium is greater than 2000 mg/kg bw in rats.
Based on the results of this study, diamminedichloropalladium does not need classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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