N-(2-phenoxyphenyl)methanesulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Investigations into the Immunotoxicity and Allergic Potential Induced by Topical Application of N-Butylbenzenesulfonamide (NBBS) in a Murine Model

Author:

Antonella Marrocco, B. Jean Meade, Carrie M. Long, Ewa Lukomska, Nikki B. Marshall, and Stacey E. Anderson

Year:

2015

Bibliographic source:

J Toxicol Environ Health A; 2015; 78(17): 1122–1132

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: method described in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Peer Review Panel report .

Principles of method if other than guideline:

N-butylbenzenesulphonamide [NBBS] was tested in a combined irritancy/local lymph node assay (LLNA) on Female BALB/c mice.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-butylbenzenesulphonamide

EC Number:

222-823-6

EC Name:

N-butylbenzenesulphonamide

Cas Number:

3622-84-2

Molecular formula:

C10H15NO2S

IUPAC Name:

N-butylbenzenesulfonamide

Test material form:

liquid: viscous

Details on test material:

Name of the test chemical:N-butylbenzenesulphonamide [NBSS]
Molecular Formula:C10H15NO2S
Molecular Weigth:213.299 g/mol
InChI: 1S/C10H15NO2S/c1-2-3-9-11-14(12,13)10-7-5-4-6-8-10/h4-8,11H,2-3,9H2,1H3
Substance Type: Organic
Physical State: Liquid

Specific details on test material used for the study:

Name of the test chemical: N-butylbenzenesulphonamide [NBSS]
Molecular Formula:C10H15NO2S
Molecular Weigth:213.299 g/mol
InChI: 1S/C10H15NO2S/c1-2-3-9-11-14(12,13)10-7-5-4-6-8-10/h4-8,11H,2-3,9H2,1H3
Substance Type: Organic
Physical State: Liquid

Test animals

Species:

mouse

Strain:

Balb/c

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Female
- Source: Taconic Farms (Germantown, NY)
- Age:5–9 weeks
- Weight at study initiation: 18-20g
- Fasting period before study: none
- Housing: housed 5 per cage in ventilated plastic shoebox cages with hardwood chip bedding
- Diet (ad libitum): NIH-31 modified 6% irradiated rodent diet (Harlan Teklad), ad libitum
- Water: tap water, ad libitum
- Acclimation period: allowed to acclimate for a minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained between 18 and 73°C
- Humidity (%): relative humidity between 30 and 70%.
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): The light/dark cycle was maintained on 12-h intervals

All animal experiments were performed in the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited National Institute for Occupational Safety and Health animal facility in accordance with an animal protocol approved by the Institutional Animal Care and Use Committee

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

other: acetone

Controls:

yes

Amount / concentration applied:

25, 50 and 100% (w/v) solution of NBSS - test group
Acetone (25 microliters) - vehicle control
dinitrofluorobenzene (DNFB) - 0.3% - positive control

Duration of treatment / exposure:

3 days

Observation period:

3 days

Number of animals:

3/group

Details on study design:

TEST SITE
- Area of exposure: ears

SCORING SYSTEM: Mice were observed daily for signs of distress or extreme irritation, for any signs of chemical-induced toxicity (ruffled fur, abnormal posture, isolation in the cage, abnormal exudates from the eyes, nose, or anus), and for local signs of irritation, including ear erythema and swelling.

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:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Dermal exposure of female BALB/c mice to the high concentration of NBBS (100%) produced no signs of overt toxicity or visual signs of inflammation at the exposure sites. A numerical increase in ear swelling was observed following exposure to NBBS (8.4, 7.2, and 5.6% for 25, 50, and 100% respectively). DNFB (0.3%), used as a positive control for irritancy studies, showed a mean significant rise of 241% ear swelling after exposure

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

N-butylbenzenesulphonamide [NBBS] was tested in a combined irritancy/local lymph node assay (LLNA) on Female BALB/c mice.
Dermal exposure of female BALB/c mice to the high concentration of NBBS (100%) produced no signs of overt toxicity or visual signs of inflammation at the exposure sites.
Hence, N-butylbenzenesulphonamide [NBSS] can be considered not irritating to skin of BALB/c mice.

Executive summary:

N-butylbenzenesulphonamide[NBBS] was tested in a combined irritancy/local lymph node assay (LLNA) on Female BALB/c mice,according to the method described in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Peer Review Panel report. Mice (3 per group) were exposed topically on each ear to 25 μl vehicle (acetone) or 25,50 or 100% NBSS. Dinitrofluorobenzene [DNFB] (0.3%) was used as a positive control. Animals were allowed to rest for 2 d following the last exposure and then euthanized via CO2 inhalation. Mice were observed daily for signs of distress or extreme irritation, for any signs of chemical-induced toxicity (ruffled fur, abnormal posture, isolation in the cage, abnormal exudates from the eyes, nose, or anus), and for local signs of irritation, including ear erythema and swelling. Animals were weighed the day prior to the first exposure and on d 4 prior to euthanasia.

Dermal exposure of female BALB/c mice to the high concentration of NBBS (100%) produced no signs of overt toxicity or visual signs of inflammation at the exposure sites. A numerical increase in ear swelling was observed following exposure to NBBS (8.4, 7.2, and 5.6% for 25, 50, and 100% respectively). DNFB (0.3%), used as a positive control showed a mean significant rise of 241% ear swelling after exposure.

Hence,N-butylbenzenesulphonamide[NBSS] can be considered not irritating to skin of BALB/c mice.