N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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:

N,N,N-tributylbutan-1-aminium bromide

Test material form:

other: crystalline powder

Details on test material:

- Name of test material: Tetrabutylammonium bromide
- Molecular formula: C16H36N.Br
- Molecular weight: 322.368
- 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 g

Duration of treatment / exposure:

3 minutes, 1 hour (1 rabbit) and 4 hours (3 rabbits)

Observation period:

14 days after application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: appr. 6cm2 (shaven back skin, hairs removed one day before treatment)
- Type of wrap if used: site of application was covered with impervious dressing secured in position with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm water
- Time after start of exposure: 3 minutes, 1 hour or 4 hours

OBSERVATION TIME POINTS
60 min., 24, 48 and 72 hours

SCORING SYSTEM:
- Draize (according to guideline)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 rabbits

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: each rabbit had score "1"

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 rabbits

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No serious skin reaction was seen after 3 minute or one hour exposure at the site of application. Four hour exposure resulted in slight erythema (barely perceptible) in all 3 rabbits directly after remmoval of the test substance, which was still seen after 24 hours. This effecst was fully reversible within 48 hours. There were no other signs of edema and other irritation.

Other effects:

No clinical signs of toxicity were noted.

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:

GHS criteria not met

Conclusions:

Based on the result from the present study it is concluded that tetrabutylammonium bromide does not have to be classified for skin irritating properties and has no obligatory labelling requirement for skin irritation.

Executive summary:

The results obtained from present study reveal that tetrabutylammonium bromide when applied to shaven back skin of rabbits in the amount of 0.5g produced very slight erythema after 4 to 24 hrs of application of the test compound. There were no other signs of edema and other irritation.

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.

Based on the result from the present study it is concluded that tetrabutylammonium bromide does not have to be classified for skin irritating properties and has no obligatory labelling requirement for skin irritation.