Tetrabutylammonium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To dertermine the skin irritation potential of test chemical.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrabutylammonium bromide

EC Number:

216-699-2

EC Name:

Tetrabutylammonium bromide

Cas Number:

1643-19-2

Molecular formula:

C16H36N.Br

IUPAC Name:

tetrabutylazanium bromide

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source : Institute for Industrial Research & Toxicology
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg±200g
Identification : By cage tag and corresponding colour body marking
Environmental conditions : Air conditioned rooms with 10-15 air changes per hour, temperature between 22-25 deg C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum

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:

no data

Observation period:

upto 14 days after application

Number of animals:

Three

Results and discussion

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:

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.

Other effects:

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.

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

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The result obtained from present study concludes that the test chemical is slightly irritatant on intact skin of New Zealand white rabbit under the test condition and has therefore been classified in the category of Skin irritant 2

Executive summary:

The skin irritation study of test chemical was performed as per OECD Guidelines 404 in three female New Zealand White rabbits and complying with the GLP procedures. The animals were prepared 24 hours prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 500gm (0.5g) of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application and the responses were scored according to Draize method. Very slight erythema was observed after 4th to 24 hours of application of test compound. The skin irritation index of test compound was calculated as 0.50. Hence, under the test conditions,the test substancecan be concluded to be slightly irritating to New Zealand White rabbit skin.