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EC number: 407-130-0 | CAS number: 65232-89-5 BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
GPMT: negative
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- 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.
: - 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
- 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
- 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
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: May cause sensitization by skin contact
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The potential of E-326 catalyst (Divanadyl pyrophosphate, CAS 65232-89-5) to cause delayed contact hypersensitivity in guinea-pigs was assessed by the Magnusson-Kligman Maximisation Test according to OECD 406. The closely-clipped dorsa of ten male and ten female Dunkin-Hartley guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 0.5% w/v E-326 catalyst in distilled water and 0.5% w/v E-326 catalyst in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 30% w/v E-326 catalyst in distilled water and the test site was covered by an occlusive dressing for 48 hours. The same induction procedures were carried out on a contemporaneous control group, except that the test material was replaced by vehicle in all doses. On Day 22, all animals were challenged by occluded application of distilled water to the left flank and, 30% and 50% w/v E-326 catalyst in distilled water to two sites on the right flank. The occlusive dressings were removed on the following day and the condition of the test sites was assessed approximately 24 and 48 hours later. Challenge application of 30% w/v E-326 catalyst in distilled water caused a significant response (slight erythema or a more marked reaction) in twelve test and three control animals. Challenge application of 5% w/v E-326 catalyst in distilled water caused a significant response in three test and no control animals. Challenge application of distilled water alone caused no dermal reaction.
It was concluded that, under the conditions of this study, repeated administration of E-326 catalyst caused delayed contact hypersensitivity in guinea-pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data andaccording to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 Divanadyl pyrophosphate (CAS 65232-89-5) has to classified as Skin Sens 1B (H317).
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