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Toxicological information

Eye irritation

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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:
2006
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

Constituent 1
Chemical structure
Reference substance name:
Triethylmethylammonium Tetrafluoroborate
Cas Number:
69444-47-9
Molecular formula:
C7H18BF4N
IUPAC Name:
Triethylmethylammonium Tetrafluoroborate
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.
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.