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EC number: 240-974-6 | CAS number: 16919-73-6
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Administrative data
Description of key information
In a GLP mouse LLNA, performed according to OECD Test Guideline 429, significant evidence (a calculated EC3 value of 11.9%) for the skin sensitising potential of diammonium hexachloropalladate was reported (Váliczkó, 2013).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8-14 May 2013 (preliminary experiment was 12-17 December 2012)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- temperature reached 26.2°C (i.e. >25°C) on one occasion. Deviation not considered to impact on validity of study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Route de Chènes Secs B.P. 4105, 53940 Le Genest-St-Isle, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 19.7-21.8 g
- Housing: individual caging (polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (a maximum of 26.2 was recorded on 30 April 2013)
- Humidity (%): 30-70
- Air changes (per hr):15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- propylene glycol
- Concentration:
- Range-finding study: 25 or 50% (w/v)
Main study: 0, 10, 25 or 50% (w/v) - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: short preliminary compatibility test performed in which solubility was assessed in acetone:olive oil (4:1), N,N-dimethylformamide, methyl ethyl ketone, propylene glycol, dimethyl sulfoxide and 1% Pluronic. Propylene glycol gave the highest concentration which was suitable for dosing (50%).
- Irritation: groups of mice (2/dose) were treated topically with 25 or 50% test substance. Mice were observed daily for signs of local irritation, changes in ear thickness, and systemic toxicity up until day 6. No adverse effects were observed.
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: the test item is regarded as a sensitiser if both of the following criteria are fulfilled:
1. That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
2. The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: groups of mice were given topical applications to the ear of 25 µl of formulation om three consecutive days (1, 2 and 3). On day 6, animals were injected with tritiated thymidine (3HTdR) and killed 5 hours later. Lymph node cell proliferation was then assessed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- As expected. See Table 1 in "Any other information on results incl. tables".
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 10.6, 14.9 and 1.3 at concentrations of 50, 25 and 10 % (w/v), respectively. Also see Table 1 in "Any other information on results incl. tables".
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 1 in "Any other information on results incl. tables".
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP mouse LLNA, performed according to OECD Test Guideline 429, significant evidence (a calculated EC3 value of 11.9%) for the skin sensitising potential of diammonium hexachloropalladate was reported.
- Executive summary:
The skin sensitising potential of diammonium hexachloropalladate has been assessed in a GLP mouse local lymph node assay (LLNA), performed according to OECD Test Guideline 429. Following a preliminary range-finding study to assess irritancy, female mice (5/group) were treated topically with 0, 10, 25 or 50% diammonium hexachloropalladate (in propylene glycol) on three consecutive days (1, 2 and 3). On day 6, cell proliferation in the local lymph nodes was measured by incorporation of injected tritiated methyl thymidine (3HTdR). No mortality or clinical signs of toxicity were observed, and there were no signs of local irritation at the application site. Observed stimulation index values were 10.6, 14.9 and 1.3 at 50, 25 and 10%, respectively. The calculated EC3 value (the concentration producing a stimulation index of 3) was 11.9%. Positive and vehicle controls performed as expected.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 8-14 May 2013 (preliminary experiment was 12-17 December 2012)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
- Justification for type of information:
- Diammonium and dipotassium hexachloropalladate are considered to fall within the scope of the read-across category "hexachloropalladate salts". See section 13 for full justification report.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- temperature reached 26.2°C (i.e. >25°C) on one occasion. Deviation not considered to impact on validity of study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Route de Chènes Secs B.P. 4105, 53940 Le Genest-St-Isle, France
- Age at study initiation: 10 weeks
- Weight at study initiation: 19.7-21.8 g
- Housing: individual caging (polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (a maximum of 26.2 was recorded on 30 April 2013)
- Humidity (%): 30-70
- Air changes (per hr):15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- propylene glycol
- Concentration:
- Range-finding study: 25 or 50% (w/v)
Main study: 0, 10, 25 or 50% (w/v) - No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: short preliminary compatibility test performed in which solubility was assessed in acetone:olive oil (4:1), N,N-dimethylformamide, methyl ethyl ketone, propylene glycol, dimethyl sulfoxide and 1% Pluronic. Propylene glycol gave the highest concentration which was suitable for dosing (50%).
- Irritation: groups of mice (2/dose) were treated topically with 25 or 50% test substance. Mice were observed daily for signs of local irritation, changes in ear thickness, and systemic toxicity up until day 6. No adverse effects were observed.
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: the test item is regarded as a sensitiser if both of the following criteria are fulfilled:
1. That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
2. The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: groups of mice were given topical applications to the ear of 25 µl of formulation om three consecutive days (1, 2 and 3). On day 6, animals were injected with tritiated thymidine (3HTdR) and killed 5 hours later. Lymph node cell proliferation was then assessed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- As expected. See Table 1 in "Any other information on results incl. tables".
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 10.6, 14.9 and 1.3 at concentrations of 50, 25 and 10 % (w/v), respectively. Also see Table 1 in "Any other information on results incl. tables".
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 1 in "Any other information on results incl. tables".
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP mouse LLNA, performed according to OECD Test Guideline 429, significant evidence (a calculated EC3 value of 11.9%) for the skin sensitising potential of diammonium hexachloropalladate was reported.
- Executive summary:
The skin sensitising potential of diammonium hexachloropalladate has been assessed in a GLP mouse local lymph node assay (LLNA), performed according to OECD Test Guideline 429. Following a preliminary range-finding study to assess irritancy, female mice (5/group) were treated topically with 0, 10, 25 or 50% diammonium hexachloropalladate (in propylene glycol) on three consecutive days (1, 2 and 3). On day 6, cell proliferation in the local lymph nodes was measured by incorporation of injected tritiated methyl thymidine (3HTdR). No mortality or clinical signs of toxicity were observed, and there were no signs of local irritation at the application site. Observed stimulation index values were 10.6, 14.9 and 1.3 at 50, 25 and 10%, respectively. The calculated EC3 value (the concentration producing a stimulation index of 3) was 11.9%. Positive and vehicle controls performed as expected.
Referenceopen allclose all
No adverse effects on body weight were observed.
The calculated EC3 value is 11.9% (w/v).
Table 1. Results of a mouse local lymph node assay on diammonium hexachloropalladate
Test Group Name |
Measured DPM |
DPM |
Number of lymph nodes |
DPN |
Group DPN |
Stimulation Index |
Background (5% trichloroacetic acid) |
42 35 |
- |
- |
- |
- |
- |
Propylene glycol |
227 |
188.5 |
2 |
94.3 |
38.4 |
1.0 |
104 |
65.5 |
32.8 |
||||
106 |
67.5 |
33.8 |
||||
80 |
41.5 |
20.8 |
||||
59 |
20.5 |
10.3 |
||||
50% DAHP |
884 |
845.5 |
2 |
422.8 |
405.0 |
10.6 |
474 |
435.5 |
217.8 |
||||
1179 |
1140.5 |
570.3 |
||||
645 |
606.5 |
303.3 |
||||
1060 |
1021.5 |
510.8 |
||||
25% DAHP |
133 |
94.5 |
2 |
47.3 |
571.5 |
14.9 |
2516 |
2477.5 |
1238.8 |
||||
2740 |
2701.5 |
1350.8 |
||||
223 |
184.5 |
92.3 |
||||
295 |
256.5 |
128.3 |
||||
10% DAHP |
66 |
27.5 |
2 |
13.8 |
51.2 |
1.3 |
121 |
82.5 |
41.3 |
||||
325 |
286.5 |
143.3 |
||||
93 |
54.5 |
27.3 |
||||
99 |
60.5 |
30.3 |
||||
25% HCA |
1137 |
1098.5 |
2 |
549.3 |
808.2 |
21.1 |
1855 |
1816.5 |
908.3 |
||||
1186 |
1147.5 |
573.8 |
||||
2840 |
2801.5 |
1400.8 |
||||
1256 |
1217.5 |
608.8 |
||||
Notes: 1. DPM (Disintegrations Per Minute) 2. DPN (Disintegrations Per Node) = DPM divided by the number of lymph nodes. 3. DAHP (Diammonium hexachloropalladate) 4. HCA (α-Hexylcinnamicaldehyde) 5. Stimulation Index = mean DPN of a treated group divided by mean DPN of the appropriate control group. |
No adverse effects on body weight were observed.
The calculated EC3 value is 11.9% (w/v).
Table 1. Results of a mouse local lymph node assay on diammonium hexachloropalladate
Test Group Name |
Measured DPM |
DPM |
Number of lymph nodes |
DPN |
Group DPN |
Stimulation Index |
Background (5% trichloroacetic acid) |
42 35 |
- |
- |
- |
- |
- |
Propylene glycol |
227 |
188.5 |
2 |
94.3 |
38.4 |
1.0 |
104 |
65.5 |
32.8 |
||||
106 |
67.5 |
33.8 |
||||
80 |
41.5 |
20.8 |
||||
59 |
20.5 |
10.3 |
||||
50% DAHP |
884 |
845.5 |
2 |
422.8 |
405.0 |
10.6 |
474 |
435.5 |
217.8 |
||||
1179 |
1140.5 |
570.3 |
||||
645 |
606.5 |
303.3 |
||||
1060 |
1021.5 |
510.8 |
||||
25% DAHP |
133 |
94.5 |
2 |
47.3 |
571.5 |
14.9 |
2516 |
2477.5 |
1238.8 |
||||
2740 |
2701.5 |
1350.8 |
||||
223 |
184.5 |
92.3 |
||||
295 |
256.5 |
128.3 |
||||
10% DAHP |
66 |
27.5 |
2 |
13.8 |
51.2 |
1.3 |
121 |
82.5 |
41.3 |
||||
325 |
286.5 |
143.3 |
||||
93 |
54.5 |
27.3 |
||||
99 |
60.5 |
30.3 |
||||
25% HCA |
1137 |
1098.5 |
2 |
549.3 |
808.2 |
21.1 |
1855 |
1816.5 |
908.3 |
||||
1186 |
1147.5 |
573.8 |
||||
2840 |
2801.5 |
1400.8 |
||||
1256 |
1217.5 |
608.8 |
||||
Notes: 1. DPM (Disintegrations Per Minute) 2. DPN (Disintegrations Per Node) = DPM divided by the number of lymph nodes. 3. DAHP (Diammonium hexachloropalladate) 4. HCA (α-Hexylcinnamicaldehyde) 5. Stimulation Index = mean DPN of a treated group divided by mean DPN of the appropriate control group. |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No human sensitisation data were identified. No in vitro skin sensitisation studies were identified, or are required, as reliable in vivo studies are already available.
The skin sensitising potential of diammonium hexachloropalladate has been assessed in a GLP mouse local lymph node assay (LLNA), performed according to OECD Test Guideline 429. Following a preliminary range-finding study to assess irritancy, female mice (5/group) were treated topically with 0, 10, 25 or 50% diammonium hexachloropalladate (in propylene glycol) on three consecutive days (1, 2 and 3). On day 6, cell proliferation in the local lymph nodes was measured by incorporation of injected tritiated methyl thymidine (3HTdR). No mortality or clinical signs of toxicity were observed, and there were no signs of local irritation at the application site. Observed stimulation index values were 10.6, 14.9 and 1.3 at 50, 25 and 10%, respectively. The calculated EC3 value (the concentration producing a stimulation index of 3) was 11.9%. Positive and vehicle controls performed as expected (Váliczkó, 2013). Diammonium hexachloropalladate is considered to fall within the scope of the read-across category "hexachloropalladate salts". See section 13 for full justification report.
Migrated from Short description of key information:
In a GLP mouse LLNA, performed according to OECD Test Guideline 429, significant evidence (a calculated EC3 value of 11.9%) for the skin sensitising potential of diammonium hexachloropalladate was reported (Váliczkó, 2013).
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 (for dipotassium or diammonium hexachloropalladate). A new study was not conducted as no standard and validated test method is available and 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.
Migrated from Short description of key information:
No respiratory tract sensitisation data are available (for dipotassium or diammonium hexachloropalladate).
Justification for classification or non-classification
Based on the results of the available and reliable mouse LLNA on diammonium hexachloropalladate, dipotassium hexachloropalladate should also be classified as a skin sensitiser (category 1B) according to EU CLP criteria (EC 1272/2008).
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