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EC number: 241-047-9 | CAS number: 16970-55-1
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- Density
- Particle size distribution (Granulometry)
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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Endpoint summary
Administrative data
Description of key information
Dihydrogen tetrachloropalladate (solution) induced skin sensitisation in an OECD Test Guideline 406 GPMT, to GLP, in which a group of ten guinea pigs were dermally challenged with 5% of the test compound following a two-stage induction with 0.05% by intradermal injection and 5% applied topically (van Huygevoort, 2003b).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 November 2002 to 3 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD,EU, EPA, Japan), to GLP,
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Dressings on 8 animals were removed early by mistake, test substance reapplied within 1 hr and exposure continued. Scoring of edema not written down
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Dressings on 8 animals were removed early by mistake, test substance reapplied within 1 hr and exposure continued. Scoring of edema not written down
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 2003
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
Kisslegg
Germany
- Age at study initiation: about 4 weeks
- Weight at study initiation: 361-393 g
- Housing: caged on purified sawdust
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.05% and 0.1% for injection and 5% epidermal application (induction)
5% for epidermal application (challenge) - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.05% and 0.1% for injection and 5% epidermal application (induction)
5% for epidermal application (challenge) - No. of animals per dose:
- 10 (test substance)
5 (controls) - Details on study design:
- RANGE FINDING TESTS:
a) one animal each injected with either 0.1 and 0.2%, or 0.02 and 0.5%, or 0.5 and 1%, or 2 and 5%. Examined 24 and 48 hr later
b) two animals each dosed topically with either 0.5 and 1%, or 2 and 5%, or 10 and 20%. Assessed at 24 and 48 hr
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal followed by topical application to the injection site one week later. Three pairs of simultaneous injections were given as follows: Freunds complete adjuvant; 0.05% test substance; 0.1% test substance emulsified in the adjuvant.
- Exposure period: 48 hr
- Test groups: 1 test and 1 control group
- Control group: treated in same way but without the test substance
- Site: scapular region, each side of the midline
- Frequency of applications: once
- Duration: 21 days
- Concentrations: 0.05% and 0.1% for injection and 5% epidermal application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hr
- Test groups: 1 test and 1 control group
- Control group: treated in same way
- Site: flank
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hr after removal of the dressing
OTHER: - Challenge controls:
- 5%
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Clinical observations:
- body weight gains normal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 9.0. Clinical observations: body weight gains normal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Clinical observations:
- body weight gains normal
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 9.0. Clinical observations: body weight gains normal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Dihydrogen tetrachloropalladate(II) induced skin sensitisation in a OECD guideline GPMT, in which a group of ten guinea pigs were dermally challenged with 5% of the test compound following a two stage induction with 0.05% by intradermal injection and 5% applied topically.
- Executive summary:
The ability of dihydrogen tetrachloropalladate to induce contact sensitisation was assessed in a OECD Test Guideline 406 guinea pig maximisation test (GPMT), conducted to GLP, using groups of 10 test and 5 control animals.
Animals were induced with 0.05% by intradermal injection, followed one week later by a second induction by topical application of 5% of the test substance under a 48-hr occlusive patch. Control animals were similarly treated but without the test substance. A challenge dose of 5% was applied under an occlusive patch for 24 hr three weeks after topical induction to both test and control animals. These doses were selected after a preliminary range-finding study.
Positive reactions were seen in 3 of the 9 animals exposed to the test substance after exposure to the challenge dose. One animal died on the day of first induction from abdominal bleeding. No reactions were observed in the control animals when examined at 24 and 48 hr after exposure to the challenge dose. No systemic toxicity was evident.
Overall, dihydrogen tetrachloropalladate induced skin sensitisation in 3 of 9 animals in the GPMT, thus requires classification as a skin sensitiser according to EU CLP criteria (EC 1272/2008).
Reference
Brown/orange staining was observed at the treated sites after challange, but this evidently did not hamper scoring of the reactions.
One animal died on the day of first induction treatment. No further mortality was reported and no systemic toxicity was observed in the surviving animals.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No relevant human sensitisation data were identified. No in vitro skin sensitisation studies were identified, or are required, as a reliable in vivo study is already available.
The ability of dihydrogen tetrachloropalladate(solution)to induce contact sensitisation was assessed in a OECD Test Guideline 406 guinea pig maximisation test (GPMT), conducted to GLP, using groups of 10 test and 5 control animals. Animals were induced with 0.05% by intradermal injection, followed one week later by a second induction by topical application of 5% of the test substance under a 48-hr occlusive patch. Control animals were similarly treated but without the test substance. A challenge dose of 5% was applied under an occlusive patch for 24 hr three weeks after topical induction to both test and control animals. These doses were selected after a preliminary range-finding study. Positive reactions were seen in 3 of the 9 animals exposed to the test substance after exposure to the challenge dose. One animal died on the day of first induction from abdominal bleeding. No reactions were observed in the control animals when examined at 24 and 48 hr after exposure to the challenge dose. No systemic toxicity was evident. Dihydrogen tetrachloropalladate(solution)induced skin sensitisation in 3 of 9 animals in the GPMT (van Huygevoort, 2003b), thus would require classification as a skin sensitiser (category 1A) according to EU CLP criteria (EC 1272/2008).
Justification for selection of skin sensitisation endpoint:
GLP study, conducted according to OECD guidelines, and the only skin sensitising study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available and reliable GPMT, dihydrogen tetrachloropalladate requires classification as a skin sensitiser (category 1A) according to EU CLP criteria (EC 1272/2008).
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