Registration Dossier
Registration Dossier
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EC number: 614-970-3 | CAS number: 69444-47-9
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-09-15 to 2006-09-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- The temperature range was 16 - 20 °C instead of 17 - 20 °C.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2005-06-01
Test material
- Reference substance name:
- tetrafluoroboranuide; triethyl(methyl)azanium
- Cas Number:
- 69444-47-9
- Molecular formula:
- C7H18BF4N
- IUPAC Name:
- tetrafluoroboranuide; triethyl(methyl)azanium
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): DIGIRENA SA TEMABF4 anhydrous
- Physical state: White powder (odourless)
- Intended use: Conductive salt in organic electrolytes for energy storage devices.
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark, desiccated, under inert gas
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: Approximately 31 to 36 weeks of age
- Weight at study initiation: Weight range of 4.70 to 5.52 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors.
- Diet: Each rabbit was offered 125 g of a standard laboratory rabbit diet (Rabbit GD Diet Pellets supplied by Highgate Farm) per day. The animals were given a dietary supplement of hay up to 48 hours before dosing.
- Water (ad libitum): Drinking water
- Acclimation period: At least ten weeks prior to the start of the study
During the acclimatisation and study period the animals were given small soft white untreated wood blocks for environmental enrichment.
ENVIRONMENTAL CONDITIONS
- Temperature: 16 to 20 °C
- Relative humidity: 40 to 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml of the test substance, weighing approximately 85 mg, was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated. The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions. - Duration of treatment / exposure:
- Not applicable
- Observation period (in vivo):
- Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. A sentinel animal was used in this study with two additional animals.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.
OBSERVATIONS:
Clinical signs: The behaviour of each rabbit was observed immediately following instillation of the test substance to allow assessment of the initial pain response (for criteria for assessment of pain response see "Any other information on materials and methods incl. tables" below).
The animals were checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed unnoticed.
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight initial pain was observed in this animal.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight initial pain was observed in this animal.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Slight initial pain was observed in this animal.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Injection of the conjunctival blood vessels was apparent in all animals during the first 24 hours after instillation persisting in one case until the 48 hour observation. Slight discharge was also evident one hour after instillation.
The treated eye of each animal was overtly normal 72 hours after instillation.
Instillation of the test substance gave rise to slight initial pain response. - Other effects:
- Clinical signs:
There was no sign of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the eyes.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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