Registration Dossier
Registration Dossier
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EC number: 407-130-0 | CAS number: 65232-89-5 BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was already available before registration
Test material
- Reference substance name:
- Divanadyl pyrophosphate
- EC Number:
- 407-130-0
- EC Name:
- Divanadyl pyrophosphate
- Cas Number:
- 65232-89-5
- Molecular formula:
- (VO)2P2O7
- IUPAC Name:
- (phosphonooxy)phosphonic acid dihydrate vanadium
- Details on test material:
- Physical state: grey/green powder
- Analytical purity: 96%
- Lot/batch No.: 326-104
- Storage condition of test material: room temperature
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: Harlan Olac Limited, Bicester, Oxfordshire, UK.
- Age at study initiation: seven to eight weeks.
- Weight at study initiation: 339 - 469 g.
- Housing: 5 animals per cage.
- Diet: Guinea pig F.D.1 (Special Diet Services, Essex, UK), ad libitum and regular supplement of autoclaved hay.
- Water: tap water ad libitum.
- Acclimation period: 13 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23 °C.
- Humidity (%): 40 - 70 %.
- Air changes (per hr): 15.
- Photoperiod (hrs dark / hrs light): 12 h / 12 h.
:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.2 mL FCA
0.2 mL of 0.5% TS in destilled water
0.2 mL of 0.5% TS in FCA - Day(s)/duration:
- day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.6 mL of 30% TS in distilled water
- Day(s)/duration:
- application on day 8, occlusive dressing for 48 hours
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.03 mL of 30% TS in distilled water and 0.03 mL of 5% TS in distilled water
- Day(s)/duration:
- application on day 22, occlusive dressing for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- destilled water (0%TS)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- destilled water (0% TS)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- destilled water (0% TS)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- destilled water (0% TS)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% TS in water
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: slight erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% TS in water
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: eschar formation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% TS in water
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: 4 animals with slight erythema, 1 with moderate erythema and 5 with eschar formation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% TS in water
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: 1 animal with slight erythema and 4 animals with eschar formation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% TS in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% TS in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% TS in water
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: 2 animals with slight erythema and 1 animal with eschar formation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% TS in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
Signs of irritation during induction: Intradermal administration in the range 5 % to 30 % w/v in distilled water caused moderate erythema and black and/or green discolouration 24 and 48 hours after administration.
Evidence of sensitisation of each challenge concentration: A significant dermal response (slight erythema or a more marked reaction) was apparent in 12 test and three control animals challenged with 30 % test substance in distilled water and in three test and no control animals challenged with the 5 % formulation. No dermal response was observed in any test or control animals following challenge with distilled water alone.
The incidence of significant responses in the test animals was markedly greater than in the controls and was in excess of the EC limit value (30 %) for classifying the test material as a dermal sensitiser. It is therefore, concluded that, under the conditions of this study, repeated administration caused delayed contact hypersensitivity in the guinea-pig.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: May cause sensitization by skin contact
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