Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-07-24 to 2006-08-24
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 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
yes
Remarks:
The temperature range was 16 - 20 °C instead of 17 - 20 °C. The test site of the initial animal was only immediately examined after the 3-minute and one-hour exposure and not after the four hour exposure.
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 odourless powder
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: At least 26 weeks of age
- Weight at study initiation: Weight range of 4.10 to 4.47 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.
- Water (ad libitum): Drinking water
- Acclimation period: At least 14 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

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The treatment site was ‘wetted’ with 0.5 mL of reverse osmosis water and approximately 0.5 g of the test
substance was applied.
Duration of treatment / exposure:
One animal (acted as a preliminary screen): three minutes, one or four hour exposure
Two additional animals: 4 hour exposure
Observation period:
Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later.
Number of animals:
3 male rabbits
Details on study design:
A single animal received three exposures (of three minutes, one or four hours duration) in a step-wise manner and acted as a preliminary screen. In the absence of a severe effect on removal of the dressings the next exposure was initiated.
Two additional animals were treated with the test item for four hours.

TEST SITE
On the day before application of the test substance, hair was removed with clippers from the dorso-lumbar region of each rabbit exposing an appropriate sized area of skin. The treatment site was ‘wetted’ with the vehicle and the test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape to intact skin sites on three animals. An additional site was similarly treated with the exception of test substance and acted as a control.
For exposures of one hour or more each treatment site was covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period. The animals were returned to their cages immediately after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: Draize scoring system

OBSERVATIONS:
Clinical signs: All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal reaction was observed in any animal throughout the duration of the study.
Other effects:
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 skin.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.