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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Tetrabutylammonium bromide was tested for its dermal irritation potential in New Zealand White Rabbits.The study was conducted according to Guideline OECD- 404 for Testing of Chemicals.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: Tetrabutylammonium bromide
- Molecular formula: C16H36N.Br
- Molecular weight: 322.368 g/mol
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: Tetrabutylammonium bromide
- Molecular formula: C16H36N.Br
- Molecular weight: 322.368 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Sec: Female
- Source: Institute for Industrial Research & Toxicology
- Age at study initiation: 0 to 12 weeks
- Weight at study initiation: 1.80kg±200g
- Housing:Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
- Identification : By cage tag and corresponding colour body marking
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
- Water (e.g. ad libitum): Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature between 22-25 deg C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
:

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 gm of test compound
Duration of treatment / exposure:
four hours
Observation period:
upto 14 days after application
Number of animals:
Three
Details on study design:
Skin reaction
The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.
Clinical signs:
In addition to the observation of irritation, all local toxic effects, such as defatting of the skin, and any systemic adverse effects were fully described and recorded.
After four hours the patch was removed and the skin reactions were graded according to Draize’s method.

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 min - 14 days
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: The skin irritation index of test compound Tetrabutylammonium bromide was calculated as: 2.00/4 = 0.50
Irritant / corrosive response data:
The test compound Tetrabutylammonium bromide applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.
Very slight erythema after 4th to 24 hrs of application of test compound. There were no other signs of edema and other irritation. These responses were graded according to Draize’s Scoring method.

Any other information on results incl. tables

TABLE – 1 : INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

Rabbit No.

Sex

INTACT SKIN

3 Min.

4 Hours

24 Hours

48 Hours

72 Hours

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

01

F

0

0

1

0

1

0

0

0

0

0

0

0

02

F

-

-

1

0

1

0

0

0

0

0

0

0

03

F

-

-

1

0

1

0

0

0

0

0

0

0

Total

0

0

3

0

3

0

0

0

0

0

0

0

Mean

0

0

1.00

0

1.00

0

0

0

0

0

0

0

Grand Total

2.00

Dermal Irritation Index: 2.00/4 = 0.50

TABLE – 2: CLINICAL SIGNS

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

Time (Day)

3

1

4

24

48

72

14

 

FEMALE

 

01

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

 

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test compound Tetrabutylammonium bromide applied on the shaven area of skin of New Zealand white rabbits in the amount of 0.5 gm showed slight skin erythema at the site of application.
The skin irritation index of test compound Tetrabutylammonium bromide was calculated as 0.50.
The results obtained from present study concluded that Tetrabutylammonium bromide was slightly irritating to skin of New Zealand white rabbits.
Executive summary:

Tetrabutylammonium bromide was tested for its dermal irritation potential in New Zealand White Rabbits. The study was conducted according to OECD Guideline 404.

In the initial test one healthy rabbit of body weight 1.80kg±200gm selected for study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment.

The site of application was covered with impervious dressing secured in position with adhesive tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. The test compound produced slight erythema at the site of application. Finally, the animal was observed for 14 days, for any irritation and corrosion. The test compound Tetrabutylammonium bromide produced slight erythema on skin at 24 hrs. Based on the above observations a confirmatory test was performed using two additional animals following same procedure. In the confirmatory test; the test compound in the amount of 0.5 gm after moistened with water was applied on the shaven back skin of two animals, each with one patch, for an exposure period of four hours.After four hours the patch was removed and the skin reactions were graded according to Draize’s method.

The test compound Tetrabutylammonium bromide applied on the shaven area of skin of New Zealand white rabbits in the amount of 0.5 gm showed slight skin erythema at the site of application. The skin irritation index of test compound Tetrabutylammonium bromide was calculated as 0.50.

The results obtained from present study concluded that Tetrabutylammonium bromide was slightly irritating to skin of New Zealand white rabbits.