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Diss Factsheets
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EC number: 939-221-0 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Decaltal N
- IUPAC Name:
- Decaltal N
- Details on test material:
- - Name of test material (as cited in study report): Decaltal N
- Physical state: solid, white
- Analytical purity: 99.57%
- Composition of test material, percentage of components: 15.5 g/100 g (tri ammonium 4-sulphonatophthalate), 4.5 g/100 g (tri ammonium 3-sulphonatophthalate), 0.7 g/100 g (di ammonium phthalate), 78.4 g/100g (ammonium sulfate), 0.47 g/100 g (water) (as determined by 1H-NMR-spectroscopy)
- Lot/batch No.: 89273636W0
- Expiration date of the lot/batch: November 09, 2013
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2-2.52 kg
- Housing: single housing
- Diet: STANRAB (P) SQC
- Water: tap water al libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (approx 16 mg of the comminuted test item) was applied to one eye - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hrs after test item application the treated eye of the animal(s) was rinsed then with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
SCORING SYSTEM:
Cornea opacity (op):
0 No ulceration or opacity
1 slight: Scattered or diffuse areas of opacity (other than slight dulling of normal
lustre), details of iris clearly visible
2 moderate: easily discernible translucent area, details of iris slightly obscured
3 marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 severe: opaque cornea, iris not discernible through the opacity
Area of cornea involved (ar):
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Area with fluorescein:
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Iris:
0 Normal
1 moderate: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 severe: no reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness (red):
0 Blood vessels normal
1 slight: some blood vessels definitely hyperemic (injected)
2 obvious: diffuse, crimson color, individual vessels not easily discernible
3 severe: diffuse beefy red
Chemosis (sw):
0 No swelling
1 slight: any swelling above normal (includes nictitating membranes)
2 moderate: obvious swelling with partial eversion of lids
3 marked: swelling with lids about half closed
4 severe: swelling with lids more than half closed
Discharge (di):
0 No discharge
1 slight: any amount different from normal (does not include small amounts observed
in inner canthus of normal animals)
2 obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 severe: discharge with moistening of the lids and hairs, and considerable area
around the eye
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.23
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: only one anmals showed slight conjunctival redness
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight conjunctival redness (grade 1) was noted in all animals at hour 1 and persisted up to 48 hours in one of these animals.
Slight conjunctival chemosis (grade 1) and slight or obvious discharge (grade 1 or 2) were noted in all animals 1 hour after application.
Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals during the observation period.
The ocular reactions were reversible in all animals within 72 hours after application at the latest.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, Decaltal N (multikonstituenter Stoff) does not show an eye irritating potential under the test conditions chosen.
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