Registration Dossier
Registration Dossier
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EC number: 432-400-1 | CAS number: 10102-09-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study performed: 26-Jul-1999 to 28-Aug-1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD), to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 1999
Test material
- Reference substance name:
- -
- EC Number:
- 432-400-1
- EC Name:
- -
- Cas Number:
- 10102-09-7
- Molecular formula:
- [Pt(NO3)x(OH)y]H2 where x = 2-5, y = 4-1, and x + y = 6
- IUPAC Name:
- platinum(4+) dihydrate tetranitrate
- Test material form:
- other: liquid
- Details on test material:
- Dark red liquid, batch number CH0139. The test material is only stable in nitric acid and is non-isolatable.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: ~8-12 weeks
- Weight at study initiation: 318-382 g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet: free access to food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water: free access to mains tap water was allowed throughout the study.
- Acclimation period: >=5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1%
Topical induction: 5%
Topical challenge: 1% and 0.5% (“the highest non-irritant concentration…and one lower concentration”, one on each flank of each test animal)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1%
Topical induction: 5%
Topical challenge: 1% and 0.5% (“the highest non-irritant concentration…and one lower concentration”, one on each flank of each test animal)
- No. of animals per dose:
- Main study: 10 test and 5 control
- Details on study design:
RANGE FINDING TESTS: performed to select concentrations for main study
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole at 5% in arachis oil
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period..
- Reading:
- other: Positive Control
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Historical positive control data for the CRO was supplied in the test report and was seen to be valid
- Remarks on result:
- not measured/tested
- Remarks:
- Historical positive control data for the CRO was supplied in the test report and was seen to be valid
Any other information on results incl. tables
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
No results tables attached, since all scores were 0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Platinum dinitrate 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 0.5 or 1% of the test compound following a two stage induction with 1% by intradermal injection and 5% applied topically.
- Executive summary:
The ability of platinum dinitrate to induce contact sensitisation was assessed in a guinea pig maximisation test (GPMT), conducted according to OECD Test Guideline 406 and to GLP, using groups of 10 test and 5 control animals.
Guinea pigs were induced with 1% 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. Challenge doses of 0.5 or 1% were 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. Platinum dinitrate was not a contact sensitiser in this GPMT.
Based on the results of this study, no classification for skin sensitisation is required according to EU CLP criteria (EC 1272/2008).
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