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EC number: 435-580-8 | CAS number: 56553-60-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-24 - 2004-10-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study according GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 1 animal was treated, remaining two animals were not treated due to severe effects
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 1 animal was treated, remaining two animals were not treated due to severe effects
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, 2003
Test material
- Reference substance name:
- -
- EC Number:
- 435-580-8
- EC Name:
- -
- Cas Number:
- 56553-60-7
- Molecular formula:
- C6H10BNaO6
- IUPAC Name:
- sodium bis(acetyloxy)boranuidyl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sodium triacetoxyborohydride
- Physical state: solid
- Analytical purity: 95%
- Lot/batch No.: LOT 30102
- Expiration date of the lot/batch: December 01, 2004
- Storage condition of test material: at room temperature at about 20°C, away from sunlight under nitrogen
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (female)
- Weight at study initiation: 2263 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bottles. Wood blocks (RCC Ltd., Füllinsdorf) and haysticks 4642 (batch no. 15/04, Provimi Kliba AG) were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet batch no. 33/04 (Provimi Kliba AG, CH-4303 Kaiseraugst, Switzerland); ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days - Number of animals or in vitro replicates:
- 1 female
- Details on study design:
- SCORING SYSTEM:
According to EEC Commision Directive 2004/73/EC, April 29, 2004
TOOL USED TO ASSESS SCORE: hand-slit lamp (Varta Cliptrix diagnostic lamp (Roth AG, CH-4135 Reinach, Switzerland)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Corneal opacity: very sligh to moderate from 1h to day 21
Iris: reduced light effect from 48 h to day 7 and on day 14. Absence of light reflex on day 10
Conjunctivy: sligh to moderate from 1h to day 21
Chemosis: marked swelling with half-closed lid or closed lid from1 to 72 h. Obvious swelling with partial eversion of lid up to day 21
Sclera: redding from 1 to 72 h, marked to slight redding from day 7 to 21
Discharge: marked from 48 to day 7 - Other effects:
- No cinical sings of systemic roxicity was observed and no mortality occured.
Any other information on results incl. tables
BAsed on the sever effects in the treated animl, no further animals were treated.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the effect on cornea and conjunctivae still persistent on day 21 at the end of observation period, Sodium triacetoxyborohydride was found to have irreversible effects on the eye.
- Executive summary:
Sodium triacetoxyborohydride was tested for irritating properties in a GLP study performed according to OECD 405. Since irritating effects were expected, 0.1 g of Sodium triacetoxyborohydride was instilled in the eye of only one New Zealand White rabbit. The mean scores for corneal opacity, iris, conjunctival erythema and chemosis were 2, 0.67, 1.67 and 4.0, respectively. In addition, the strong effects on cornea and conjunctivae still persistent on day 21 at the end of observation period, so that Sodium triacetoxyborohydride was found to have irreversible effects on the eye.
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