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EC number: 692-731-2 | CAS number: 76950-43-1
- 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:
- 25 Mar - 08 Apr 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- Aug 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Argricultural Materials Inspection Centre (FAMIC), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Health Care Inspectorate, Ministry of Health, Welfare and Sport, Den Haag, The Netherlands
Test material
- Reference substance name:
- {1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
- EC Number:
- 692-731-2
- Cas Number:
- 76950-43-1
- Molecular formula:
- C7H14N2O
- IUPAC Name:
- {1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Substance type: off-white powder with lumps
- Analytical purity: 90.7% (subsequent information by sponsor)
- Impurities (identity and concentrations): 1,5-diazabicyclo[3.2.2]nonane-3-ol 8.9% (subsequent information by sponsor)
- Expiration date of the lot/batch: 20 Dec 2014
- Storage condition of test material: at room temperature in the dark
- Other: pH: 11.0 at concentration of 10%
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 France, L'Arbresle, France
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.59 kg - 2.92 kg
- Housing: individually in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters
- Diet: pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy) approx. 100 g per day; hay and wooden sticks were available
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 Mar 2014 To: 08 Apr 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- the test material was ground to a powder
- Amount applied: 31.9 mg (range 31.8 - 32.1 mg) (equivalent to a volume of approx. 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: solution of 2% fluorescein in water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- There was no evidence of ocular corrosion. Instillation of the test substance into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in two animals and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals.
No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. - Other effects:
- No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
Any other information on results incl. tables
Table 1. Results of eye irritation study
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
|
redness |
swelling |
||||
1 |
1 |
2 |
2 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
7d |
0 |
0 |
0 |
0 |
|
average |
1,7 |
0,3 |
0,0 |
0,0 |
|
2 |
1 |
2 |
2 |
1 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
2 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
7d |
0 |
0 |
0 |
0 |
|
average |
1,7 |
0,7 |
0,0 |
0,0 |
|
3 |
1 |
2 |
2 |
1 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
7d |
0 |
0 |
0 |
0 |
|
average |
1,7 |
0,3 |
0,0 |
0,0 |
|
|
|
||||
Time [h] |
conjunctivae |
iris
|
cornea
|
||
|
redness |
swelling |
|||
average |
1 |
2,00 |
2,00 |
0,67 |
0,00 |
24 |
2,00 |
1,00 |
0,00 |
0,00 |
|
48 |
2,00 |
0,33 |
0,00 |
0,00 |
|
72 |
1,00 |
0,00 |
0,00 |
0,00 |
|
7d |
0,00 |
0,00 |
0,00 |
0,00 |
|
24+48+72 |
1,67 |
0,44 |
0,00 |
0,00 |
No mortality occurred and no signs of systemic toxicity were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
DSD: not classified
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