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EC number: 910-853-9 | CAS number: 8011-63-0
- 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
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:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not conducted because adequate data from a guine-pig maximisation test are already available. The available study was conducted prior to the date on whch the LLNA became the method of choice.
Test material
- Reference substance name:
- calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
- EC Number:
- 910-853-9
- Cas Number:
- 8011-63-0
- Molecular formula:
- Ca3Cu4H6O22S4.nH2O where n = 1 to 6
- IUPAC Name:
- calcium tetracopper(2+) dioxocopperbis(olate) hexahydroxide sulfate
- Details on test material:
- - Name of test material (as cited in study report): Bordeaux Mixture
- Composition of test material, percentage of components: 26.35% w/w as copper
- Lot/batch No.: 44
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Adult Dunkin-Hartley guinea pigs, weighing 374 + 17 g (males) and 360 + 21 g (females) at initiation were used for the main test.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9% sodium chloride solution
- Concentration / amount:
- See Details on Study Design.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% sodium chloride solution
- Concentration / amount:
- See Details on Study Design.
- No. of animals per dose:
- See Details on Study Design.
- Details on study design:
- RANGE FINDING TESTS:
An initial irritation screening test was performed to determine the highest non-irritant concentration for the challenge phase of the study and an irritant concentration for the induction phase. A concentration of 0.1% w/w in the vehicle produced moderate irritation by injection and was selected for the intradermal induction phase. By the topical route, 30% w/w in the vehicle produced no irritation (the highest non-irritant concentration) and was selected for the topical induction phase and challenge.
MAIN STUDY:
A. INDUCTION EXPOSURE
Intradermal injections of test substance (0.1% w/w) in 0.9% sodium chloride, FCA at 50% v/v dilution with 0.9% sodium chloride and test substance (0.1% w/w) in FCA/0.9% sodium chloride (50:50 v/v) were administered to the interscapular region of 20 animals (10 male, 10 female). Ten control animals (five males, five females) received FCA at 50% v/v dilution with 0.9% sodium chloride, 0.9% sodium chloride and 0.9% sodium chloride at 50% w/w in FCA/0.9% sodium chloride (50:50 v/v). After six days, the interscapular region of the animals was clipped and treated with 0.5 mL of sodium lauryl sulphate at a concentration of 10% w/w in vaseline to induce local irritation. The next day, the topical induction phase was performed on the test animals: a filter paper pad (8 cm2 in area) was fully loaded with a 30% concentration of the test substance and applied to the shaved interscapular area previously injected and held in place for 48 hours with an occlusive dressing. Control animals received a filter paper pad fully loaded with 0.9% sodium chloride for the same period.
B. CHALLENGE EXPOSURE
21 days after initiation, the filter paper pad of a ‘Finn Chamber’ was fully loaded with the challenge dose of 30% w/w test substance in vehicle and applied to a naïve shaved site on test and control animals and held in place for 24 hours with an occlusive dressing. The challenge patch was removed and the animals were examined for erythema as indication of a sensitisation response 24 and 48 hours after removal of the dressings. Results were compared with earlier controls run at the same laboratory with mercaptobenzothiazole.
Results and discussion
- Positive control results:
- Positive reactions were recorded with mercaptobenzothiazole consistent with its known sensitising potential.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% w/w
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Discrete or moderate erythema (score 1 or 2)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% w/w. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Discrete or moderate erythema (score 1 or 2).
Any other information on results incl. tables
No skin reaction was recorded in the control animals 24 hours or 48 hours after challenge or in the test animals 24 hours after challenge. 48 hours after challenge, a discrete or moderate erythema (score 1 or 2) was recorded in four of the 20 test animals. See Table 1.
Table 1. Skin Sensitisation Challenge Response
Group |
Topical induction treatment |
Incidence of significant response |
Total responders |
|
24 hours |
48 hours |
|||
Control |
vehicle (sodium chloride) |
0/10 |
0/10 |
0/10 |
Bordeaux Mixture (30% w/w) |
0/10 |
0/10 |
0/10 |
|
Treated |
vehicle (sodium chloride) |
0/20 |
0/20 |
0/20 |
Bordeaux Mixture (30% w/w) |
0/20 |
4/20 |
4/20 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bordeaux Mixture induced skin sensitisation in 20% of animals in the maximisation test i.e. less than the 30% threshold.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified. - Executive summary:
A GLP-compliant guinea-pig maximisation test was carried out in accordance with the requirements of OECD 406, EU B.6 and US EPA OPPTS 870.2600 without significant deviation. An initial irritation screening test was performed to determine the highest non-irritant Bordeaux Mixture concentration for the challenge phase of the study and an irritant concentration for the induction phase. A concentration of 0.1% w/w in the vehicle (0.9% sodium chloride solution) produced moderate irritation by injection and was selected for the intradermal induction phase. By the topical route, 30% w/w in the vehicle produced no irritation (the highest non-irritant concentration) and was selected for the topical induction phase and challenge. Adult Dunkin-Hartley guinea pigs, weighing 374 + 17 g (males) and 360 + 21 g (females) at initiation were used for the main test. Intradermal injections of test substance (0.1% w/w) in 0.9% sodium chloride, FCA at 50% v/v dilution with 0.9% sodium chloride and test substance (0.1% w/w) in FCA/0.9% sodium chloride (50:50 v/v) were administered to the interscapular region of 20 animals (10 male, 10 female). Ten control animals (five males, five females) received FCA at 50% v/v dilution with 0.9% sodium chloride, 0.9% sodium chloride and 0.9% sodium chloride at 50% w/w in FCA/0.9% sodium chloride (50:50 v/v). After six days, the interscapular region of the animals was clipped and treated with 0.5 mL of sodium lauryl sulphate at a concentration of 10% w/w in vaseline to induce local irritation. The next day, the topical induction phase was performed on the test animals: a filter paper pad (8 cm2in area) was fully loaded with a 30% concentration of the test substance and applied to the shaved interscapular area previously injected and held in place for 48 hours with an occlusive dressing. Control animals received a filter paper pad fully loaded with 0.9% sodium chloride for the same period. 21 days after initiation, the filter paper pad of a ‘Finn Chamber’ was fully loaded with the challenge dose of 30% w/w test substance in vehicle and applied to a naïve shaved site on test and control animals and held in place for 24 hours with an occlusive dressing. The challenge patch was removed and the animals were examined for erythema as indication of a sensitisation response 24 and 48 hours after removal of the dressings. Results were compared with earlier controls run at the same laboratory with mercaptobenzothiazole.
No skin reaction was recorded in the control animals 24 hours or 48 hours after challenge or in the test animals 24 hours after challenge. 48 hours after challenge, a discrete or moderate erythema (score 1 or 2) was recorded in four of the 20 test animals. As skin sensitisation was induced in only 20% of animals in the maximisation test, it is concluded that Bordeaux Mixture is not classified as a skin sensitizer.
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