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Description of key information

Palladium dinitrate dihydrate failed to induce skin sensitisation in an OECD Test Guideline 406 GPMT, to GLP, in which a group of ten guinea pigs were dermally challenged with 2% of the test compound following a two stage induction with 0.1% by intradermal injection and 2% applied topically (van Huygevoort, 2003b).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 January 2003 to 13 March 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD, EU, EPA), to GLP, on the dihydrate, with minor deviations (humidity) that are not considered to affect the validity of the study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
deviations form the minimum humidity level recommended, which were not considered to have affected the study integrity.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
deviations form the minimum humidity level recommended, which were not considered to have affected the study integrity.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
yes
Remarks:
deviations form the minimum humidity level recommended, which were not considered to have affected the study integrity.
Qualifier:
according to guideline
Guideline:
other: Japanese MAFF
Deviations:
yes
Remarks:
deviations form the minimum humidity level recommended, which were not considered to have affected the study integrity.
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 5 weeks
- Weight at study initiation: 310-355 g
- Housing: 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


Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
0.1% for injection and 2% epidermal application (induction)
2% for epidermal application (challenge)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.1% for injection and 2% epidermal application (induction)
2% for epidermal application (challenge)
No. of animals per dose:
10 in test group
5 in control group
Details on study design:
RANGE FINDING TESTS: three animals each injected with either 0.1 and 0.2%, or 0.5 and 1%, or 2 and 5%. Examined 24 and 48 hr later
b) two animals each dose conbination dosed topically with either 0.5 and 1%, or 2 and 5%. Assessed at 24 and 48 hr

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection followed by topical application to the injection site one week later. Three pairs of simultaneous injections were given as follows: Freunds complete adjuvant; 0.1% test substance; test substance emulsified in the adjuvant.
- Exposure period: 48 hr - dermal application
- 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: 0.1% for injection and 2% epidermal application

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hr
- Test groups: 1 test and 1 control group
- Control group: treated in same way
- Site: flank
- Concentrations: 2%
- Evaluation (hr after challenge): 24 and 48 hr after removal of the dressing

OTHER:

Challenge controls:
Treated with 2%
Positive control substance(s):
no
Remarks:
Not as part of study but routine checked (last check October/November 2002)
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No systemic toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No systemic toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic toxicity.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No systemic toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No systemic toxicity.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No systemic toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No systemic toxicity.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Palladium dinitrate dihydrate failed to induce skin sensitisation in an OECD Test Guideline 406 GPMT, to GLP, in which a group of ten guinea pigs were dermally challenged with 2% of the test compound following a two stage induction with 0.1% by intradermal injection and 2% applied topically.
Executive summary:

The ability of palladium dinitrate dihydrate 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 females.

Animals were induced with 0.1% by intradermal injection, followed one week later by a second induction by topical application of 2% of the test substance under a 48 -hr occlusive patch. Control animals were similarly treated but without the test substance. A challenge dose of 2% was applied under an occlusive patch for 24 hr, three weeks after the start of induction to both test and control animals. These doses were selected after a preliminary range-finding study to determine irritation. Scoring of the treated areas was carried out 24 and 48 hr after removal of the patches.

No positive reactions were observed in the test or control animals on examination at 24 and 48 hr after removal of the challenge patches.

Overall, palladium dinitrate dihydrate was not a contact sensitiser in a reliable GPMT, andthus would not require classification as a skin sensitiser according to EU CLP criteria (EC 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No relevant human sensitisation data were identified. No in vitro skin sensitisation studies were identified, or are required, as an adequate in vivo study is already available.

 

The ability of palladium dinitrate dihydrate to induce contact sensitisation was assessed in an OECD Test Guideline 406 guinea pig maximisation test (GPMT), conducted to GLP, using groups of 10 test and 5 control females. Animals were induced with 0.1% by intradermal injection, followed one week later by a second induction by topical application of 2% of the test substance under a 48-hr occlusive patch. Control animals were similarly treated but without the test substance. A challenge dose of 2% was applied under an occlusive patch for 24 hr, three weeks after the start of induction, to both test and control animals. These doses were selected after a preliminary range-finding study to determine irritation. Scoring of the treated areas was carried out 24 and 48 hr after removal of the patches. No positive reactions were observed in the test or control animals on examination at 24 and 48 hr after removal of the challenge patches. Overall, palladium dinitrate dihydrate was not a contact sensitiser in a reliable GPMT (van Huygevoort, 2003b), and thus would not require classification as a skin sensitiser 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. 



Migrated from Short description of key information:
No respiratory tract sensitisation data are available.

Justification for classification or non-classification

Based on the results of the available and reliable GPMT, palladium dinitrate dihydrate does not require classification as a skin sensitiser according to EU CLP criteria (EC 1272/2008).