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EC number: 425-270-0 | CAS number: 134620-00-1
- 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 (OECD TG 404), no irritation potential was observed when 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened in water, was applied (semi-occluded for 4 hr) to the intact shaved skin of three rabbits (Allen, 1995b).
In an OECD guideline study, no irritation potential was observed when tetraamminepalladium dichloride was applied (under occlusion for 4 hr) to the intact shaved skin of three rabbits (Driscoll, 1981).
In a guideline study (OECD TG 405), to GLP, undiluted tetraamminepalladium hydrogen carbonate (0.1 mL; 91 mg) produced severe eye irritation following instillation into the eye of one rabbit. The animal was killed at 24 hours for humane reasons (Allen, 1995c).
In an OECD Guideline study, to GLP, instillation of undiluted tetraamminepalladium dichloride to one eye of each of three rabbits (without subsequent washing) caused moderate to severe irritation, and severe irritation in three rabbits when the eye was rinsed after 30 seconds (Driscoll and Collier, 1981).
No relevant respiratory tract irritation 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- OECD guideline study to GLP. Limited reporting (e.g. test purity and exposure area)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sanbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.6 and 2.71 kg (females) and 2.69 kg (male)
- Fasting period before study: no data
- Housing: individually housed in suspened metal cages
- Diet (e.g. ad libitum): ab libitum
- Water (e.g. ad libitum): ab libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 49-56
- Air changes (per hr): about 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with 0.5 ml of distilled water) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 (2 females and 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: cotton gauze patch (2.5 x 2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing. Residual test material removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.
SCORING SYSTEM: Individual scores for erythema/eschar and oedema were made for the three rabbits according to the Draize classification scheme at the 1, 24, 48 and 72-hr readings. The mean of the scores at the 24 and 72-hr observations were summed, and divided by 6 to give the primary irritation index. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72-hour observations
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- female 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- female 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- female 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- female 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation or corrosive effects seen during the study.
- Other effects:
- Yellow-staining was noted at all treated sites at 1, 24, 48 and 72-hr observations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an OECD guideline study, to GLP, no irritation was observed when 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened in water, was applied (semi-occluded for 4 hr) to the intact shaved skin of three New Zealand white rabbits.
- Executive summary:
In an OECD Test Guideline 404 study, to GLP, 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened with 0.5 mL of distilled water, was applied (semi-occluded) to the intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours.
Yellow-staining was noted at all treated skin sites at 1, 24, 48 and 72 hrs. No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the study period. The primary irritation index was therefore 0, and tetraamminepalladium(II) hydrogen carbonate was classified as non-irritating.
No skin irritation classification required, according to EU CLP criteria (EC 1272/2008), on the basis of this study.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 to 21 November 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- individual experimental studies were not inspected for GLP compliance. Inspections of skin irritation studies were reported to be carried out 19-20 February 1981
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University
School of Agriculture
Sutton Bonington
Leicestershire
UK
- Age at study initiation: no data
- Weight at study initiation: 2.34-3.19 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): no data
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: no concurrent control site
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water to make a paste
VEHICLE
no data - Duration of treatment / exposure:
- 4 hr
- Observation period:
- 72 hr with an additional 7 day observation period if irritation was still apparent at 72 hr
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: absorbent lint covered with polythene, secured by adhesive tape. The trunk of each rabbit was wrapped in an elasticated bandage (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hr
SCORING SYSTEM: assessed at 1, 24, 48 and 72 hr. Scored using the method of Draize (1959) for erythema/eschar formation and edema at all time points and the total scores were divided by 12 to hive the primary irritation index.
Primary irritation index Classification
0 non-irritant
> 0-2 mild irritant
> 2-5 moderate irritant
> 5-8 severe irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hr time points
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no irritation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- None seen at any time point
- Other effects:
- No indication of whether systemic effects were assessed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, no irritation potential was observed when tetraammine palladous chloride was applied (under occlusion for 4 hr) to the intact shaved skin of three rabbits.
- Executive summary:
In an OECD Test Guideline 404 study, tetraammine palladous chloride (0.5 g, moistened) was applied (occluded) to the clipped but intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours.
No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the 72 hr study period. The primary irrational index was therefore 0, and tetraammine palladous chloride is classified as non-irritating.
No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 18 to 21 November 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Within the category of tetraamminepalladium(II) compounds, data on three tetraamminepalladium(II) salts, the acetate, chloride, and hydrogen carbonate salts will be used to fill data gaps. Tetraamminepalladium(II) diacetate, dinitrate, dihydroxide, dichloride and di(hydrogencarbonate) are the target substances within the group. In all substances covered, the palladium is in the 2+ oxidation state, co-ordinated to four neutral ammonia molecules (giving an overall 2+ charge on the complex). Thus, the difference in anion (acetate, nitrate, hydroxide, chloride or hydrogen carbonate) represents the only structural difference between the compounds in this group. As detailed in the read-across justification report (cfr IUCLID section 13), all the human health toxicity data included in the category member dossiers should be considered equally applicable to each of the category member substances.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- individual experimental studies were not inspected for GLP compliance. Inspections of skin irritation studies were reported to be carried out 19-20 February 1981
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University
School of Agriculture
Sutton Bonington
Leicestershire
UK
- Age at study initiation: no data
- Weight at study initiation: 2.34-3.19 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): no data
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: no concurrent control site
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water to make a paste
VEHICLE
no data - Duration of treatment / exposure:
- 4 hr
- Observation period:
- 72 hr with an additional 7 day observation period if irritation was still apparent at 72 hr
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: absorbent lint covered with polythene, secured by adhesive tape. The trunk of each rabbit was wrapped in an elasticated bandage (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hr
SCORING SYSTEM: assessed at 1, 24, 48 and 72 hr. Scored using the method of Draize (1959) for erythema/eschar formation and edema at all time points and the total scores were divided by 12 to hive the primary irritation index.
Primary irritation index Classification
0 non-irritant
> 0-2 mild irritant
> 2-5 moderate irritant
> 5-8 severe irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hr time points
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no irritation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- None seen at any time point
- Other effects:
- No indication of whether systemic effects were assessed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, no irritation potential was observed when tetraammine palladous chloride was applied (under occlusion for 4 hr) to the intact shaved skin of three rabbits.
- Executive summary:
In an OECD Test Guideline 404 study, tetraammine palladous chloride (0.5 g, moistened) was applied (occluded) to the clipped but intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours.
No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the 72 hr study period. The primary irrational index was therefore 0, and tetraammine palladous chloride is classified as non-irritating.
No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.
Referenceopen allclose all
Very slight yellowing staining of the test site which did not interfere with the assessment of irritation
Very slight yellowing staining of the test site which did not interfere with the assessment of irritation
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:
- 15-16 March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Motson, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.60 kg
- Housing: Individually housed in a suspended metal cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 deg C
- Humidity (%): 49-50%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 15 March 1995 To: 16 March 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye acted as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to 91 mg)
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours [animal was killed for humane reasons after 24 hours due to signs of pain and discomfort]
- Number of animals or in vitro replicates:
- One
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: Not applicable
SCORING SYSTEM: Modified Kay and Calandra classification system
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 53
- Max. score:
- 110
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 81
- Max. score:
- 110
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 40
- Max. score:
- 80
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 60
- Max. score:
- 80
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritant / corrosive response data:
- Translucent corneal opacity was noted at the 1-hour observation with opalescent corneal opacity at the 24-hour observation.
Iridial inflammation was noted at the 1 and 24-hour observations.
Moderate conjunctival irritation was noted at the 1-hour observation with severe conjunctival irritation at the 24-hour observation.
The nictitating and conjunctival membranes were pale in appearance with petechial haemorrhage of the nictitating membrane at the 1 and 24-hour observations.
Due to signs of pain and discomfort the animal was killed after 24-hour observation for humane reasons. - Other effects:
- Residual test material was noted in the treated eye 1 and 24 hours after treatment.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, undiluted tetraamminepalladium(II) hydrogen carbonate (0.1 mL; 91 mg) produced very severe eye irritation following instillation into the eye of one rabbit. The animal was killed at 24 hours for humane reasons.
- Executive summary:
In an OECD guideline study (TG 405), conducted according to GLP, undiluted tetraamminepalladium(II) hydrogen carbonate (0.1 mL; 91 mg), was instilled into one eye of a single New Zealand white rabbit. The other eye remained untreated and acted as the control.
The treated eye was assessed, after 1 and 24 hours, using a modified Kay and Calandra classification system for signs of irritation on the cornea, iris and conjunctiva.
Tetraamminepalladium(II) hydrogen carbonate produced a maximum group mean score of 81.0 [maximum total score possible = 110] at 24 hours. The animal was killed at 24 hours for humane reasons and no further animals were tested.
The substance was, therefore, considered a very severe irritant in this test system. As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 to 28 December 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study, to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.36-3.16 kg
- Housing: metal cages
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): no data
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, concurrent no treatment; other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- After 30 seconds (“with rinsing” group) or throughout observation period ("without rinsing” group)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 in the “without rinsing” group; 3 in the “with rinsing” group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes in one group
- Time after start of exposure: 30 seconds with 100 ml sterile distilled water at 37oC (one group)
SCORING SYSTEM: According to the numerical evaluation of Draize. For each tissue the total score was calculated as follows:
Total score for conjunctivae = (redness + chemosis + discharge) x 2
Total score for iris = any changes x 5
Total score for cornea = (degree of opacity x area of opacity) x 5
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hr, and 7 days
- Score:
- 27
- Reversibility:
- not fully reversible within: 7 days in two of the three animals
- Irritation parameter:
- overall irritation score
- Remarks:
- with rinsing
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hr, and 7 days
- Score:
- 31
- Reversibility:
- not fully reversible within: 7 days in two of the rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Without washing: One hour after treatment irritation showed as iridial congestion, conjunctival reness and severe chemosis. By seven days post treatment minimal chemosis was present in one animal and minimal chemosis and redness in another.
With washing: One hour following treatment irritation was exhibited as slight corneal opacity and iridial congestion in two rabbits, and slight to moderate conjunctival redness and moderate to severe chemosis in all three animals, which had not improved by 72 hours. By day 7 significant irritation was still persistent in the cornea and conjunctivae of two rabbits. - Other effects:
- There is no indication that clinical signs of systemic toxic effects were evident.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In an OECD Guideline study, to GLP, instillation of undiluted tetraammine palladous chloride to one eye of each of three rabbits without washing caused moderate to severe irritation and severe irritation in three rabbits when the eye was rinsed after 30 seconds
- Executive summary:
In an OECD Guideline study, to GLP, undiluted tetraammine palladous chloride (100 mg, powdered) was instilled into the right eye of each of six New Zealand. The contralateral eye remained untreated and was used for control purposes. In half of the animals, the eyes were rinsed after 30 seconds with 100 ml of sterile distilled water.
Moderate to severe irritation was observed in the ‘non-rinsed group’, which (although had reduced in severity) was not fully reversible in two of the 3 rabbits within seven days after treatment. When the eyes were rinsed after a 30 second exposure, the test substance caused severe eye irritation in all three rabbits which (although had reduced in severity) still persisted at day 7 in two of the animals. No clinical signs of systemic toxic effects were reported.
Overall, tetraammine palladous chloride caused severe irritation to the eye of rabbits observed for a seven day period. Classification as an eye irritant (category 2), is required on the basis of the findings of this study and according to EU CLP criteria (EC 1272/2008).
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Irritation Parameter | Time after treatment |
|
1 hour | 24 hours | |
Cornea | ||
Degree of opacity | 2 | 3 |
Area of opacity | 4 | 4 |
Score | 40 | 60 |
Iris | 1 | 1 |
Score | 5 | 5 |
Conjunctivae | ||
Redness | 2 | 2 |
Chemosis | 2 | 3 |
Discharge | 0 | 3 |
Score | 8 | 16 |
Total score | 53 | 81 |
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 an OECD Test Guideline 404 study, to GLP, 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened with 0.5 mL of distilled water, was applied (semi-occluded) to the intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours. Yellow-staining was noted at all treated skin sites at 1, 24, 48 and 72 hrs. No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the study period. The primary irritation index was therefore 0, and tetraamminepalladium(II) hydrogen carbonate was classified as non-irritating (Allen, 1995b).
In an OECD Test Guideline 404 study, neat tetraamminepalladium dichloride (0.5 g, moistened) was applied (occluded) to the clipped but intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours. No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the 72-hr study period. The primary irrational index was therefore 0, and tetraamminepalladium dichloride is classified as non-irritating (Driscoll, 1981). No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.
In an OECD guideline study (TG 405), conducted according to GLP, undiluted tetraamminepalladium(II) hydrogen carbonate (0.1 mL; 91 mg), was instilled into one eye of a single New Zealand white rabbit. The other eye remained untreated and acted as the control. The treated eye was assessed, after 1 and 24 hours, using a modified Kay and Calandra classification system for signs of irritation on the cornea, iris and conjunctiva. Tetraamminepalladium(II) hydrogen carbonate produced a maximum group mean score of 81.0 [maximum total score possible = 110] at 24 hours. The animal was killed at 24 hours for humane reasons and no further animals were tested. The substance was, therefore, considered a severe irritant in this test system (Allen, 1995c).
In an OECD Guideline study, to GLP, undiluted tetraamminepalladium dichloride (100 mg, powdered) was instilled into the right eye of each of six New Zealand rabbits. The contralateral eye remained untreated and was used for control purposes. In half of the animals, the eyes were rinsed after 30 seconds with 100 ml of sterile distilled water. Moderate to severe irritation was observed in the ‘non-rinsed group’, which (although had reduced in severity) was not fully reversible in two of the 3 rabbits within seven days after treatment. When the eyes were rinsed after a 30-second exposure, the test substance caused severe eye irritation in all three rabbits which (although reduced in severity) still persisted at day 7 in two of the animals. No clinical signs of systemic toxic effects were reported. Tetraamminepalladium dichloride caused severe irritation to the eye of rabbits observed for a 7-day period (Driscoll and Collier, 1981). Classification of tetraamminepalladium dichloride as an eye irritant (category 2), is required on the basis of the findings of this study and according to EU CLP criteria (EC 1272/2008).
No respiratory tract irritation data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available skin irritation studies (in rabbits), tetraamminepalladium(II) hydrogen carbonate does not require classification as a skin irritant.
Regarding eye irritation, as the results of the test with tetraamminapalladium(II) hydrogen carbonate were based on only one rabbit, it is not possible to give a definitive classification interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.
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