Ethylbenzenesulphonic acid

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:

Dermal Irritation Assessment of Three Benzene Sulfonate Compounds

Author:

Chin H. Tay,Barbara T. Pugh,Stephen R. Clough and Brian H. Magee

Year:

2004

Bibliographic source:

International Journal of Toxicology ,January 2004 vol. 23 no. 1 pp.11-16

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Principles of method if other than guideline:

A Skin irritation study was performed on New Zealand White rabbits to assess the irritation potential of Sodium benzene sulfonate

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium benzenesulphonate

EC Number:

208-198-2

EC Name:

Sodium benzenesulphonate

Cas Number:

515-42-4

Molecular formula:

C6H6O3S.Na

IUPAC Name:

Sodium benzene sulfonate

Test material form:

solid

Details on test material:

Name of the test chemical: Sodium benzene sulfonate
Molecular Formula:C6H6O3S.Na
Molecular Weight:180.1585 g/mol
InChI:1S/C6H6O3S.Na/c7-10(8,9)6-4-2-1-3-5-6;/h1-5H,(H,7,8,9);/q;+1/p-1
Substance Type:Organic
Physical State:Solid

Specific details on test material used for the study:

Name of the test chemical: Sodium benzene sulfonate
Molecular Formula:C6H6O3S.Na
Molecular Weight:180.1585 g/mol
InChI:1S/C6H6O3S.Na/c7-10(8,9)6-4-2-1-3-5-6;/h1-5H,(H,7,8,9);/q;+1/p-1
Substance Type:Organic
Physical State:Solid
Lot Number: DU 11227LN
Purchased from: purchased from Sigma-Aldrich

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Rabbit Breeding Labs in Amherst, MA.
- Age at study initiation:10 weeks old
- Weight at study initiation: between 2.03 and 2.24 kg
- Fasting period before study:No data
- Housing: Rabbits were housed individually in suspended stainless steel cages with noncontact hardwood chips as bedding
- Diet (e.g. ad libitum): TEK 8630 Rabbit Diet;ad libitum
- Water (e.g. ad libitum): tap water, ad libitum.
- Acclimation period:No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 deg.F (±5 deg.F) (20deg.C)
- Humidity (%):between 30% and 70%
- Air changes (per hr): 10 to 15 air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle of full spectrum fluorescent lights

IN-LIFE DATES: From: To:No data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Distillled water

Controls:

yes

Amount / concentration applied:

four doses were applied: 5000 mg/L, 2000 mg/L, 1000 mg/L, and 500 mg/l

Duration of treatment / exposure:

4-hrs.

Observation period:

1, 24, 48, and 72 hours after patch removal

Number of animals:

6 male and 6 female per dose group

Details on study design:

TEST SITE
- Area of exposure: small area of skin(rabbits trunk)
- % coverage: approximately 6cm2
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the patches were
removed and the skin wiped to remove any test substance still remaining
- Time after start of exposure: At the end of the 4-hour exposure period

SCORING SYSTEM: Draize Scale for Scoring Skin Reactions (USEPA 1998)
This scale assesses irritation as follows: 0, no erythema or edema; 1, very slight erythema and/or edema (barely perceptible); 2, well-defined erythema and/or slight edema; 3, moderate to severe erythema or moderate edema, and 4, severe erythema and/or edema.

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour after patch removal

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: very slight erythema was observed

Remarks:

dose level 5000mg/l

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour after patch removal

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: very slight erythema was observed

Remarks:

dose level 2000mg/l

Irritant / corrosive response data:

At a dose of 5000 mg/L, very slight erythema (Draize Score 1) was observed in all three test animals 1 hour after removal of the gauze containing the benzene sulfonate solution. At the 24-hour observation point, very slight irritation (Draize Score 1) was observed in one of the three test animals. At the 48- and 72-hour observation points, the irritation was reversed, and no irritation was observed in any of the animals. Edema was not observed at any time. Control skin showed no signs of irritation. At 2000 mg/L, very slight erythema (Draize Score 1) was observed in two of the three test animals 1 hour after removal of the benzene sulfonate solution. The irritation was reversed by 24 hours. No erythema was observed in any test animals at this dosage at 24, 48 or 72 hours.

Any other information on results incl. tables

Table 1: Clinical Observations

Compound	Dosage^a(mg/l)	N	Body weight (kg)b		Weight change^b	Signs of toxicity^c
			Day 0	Day 3
Benzene sulphonate	5000	3	2.18±0.030	2.22±0.036	0.04±0.010	none
Benzene sulphonate	2000	3	2.16±0.072	2.20±0.066	0.04±0.010	none
Benzene sulphonate	1000	3	2.11±0.072	2.16±0.064	0.05±0.012	none
Benzene sulphonate	500	3	2.12±0.072	2.17±0.072	0.05±0.012	none

 

a- Dermal application volume was 0.5 ml.

b- Values expressed as mean ± standard deviation.

c- Excluding dermal observations of erythema or edema.

 

Table 2: Summary of irritation tests for benzene sulphonate                                      

Time (in hours)^a	Concentration applied^b(mg/l)	Effects
1	5000	Very slight or well defined erythema in all animals
24		Very slight erythema in 1 of 3 animals
48		None observed
72		None observed
Conclusion		Slight irritant reversible in 48 hours
1	2000	Mild erythema in 2 of 3 animals
24		None observed
48		None observed
72		None observed
Conclusion		Slight irritant reversible in 24 hours
1	1000	None observed
24		None observed
48		None observed
Conclusion		Not an irritant
1	500	None observed
24		None observed
48		None observed
Conclusion		Not an irritant

 

a-     Time refers to time elapsed following the 4-hour exposure to the test substance.

b-     Dermal application volume was 0.5 ml.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

At a dose of 5000 mg/L, very slight erythema (Draize Score 1) was observed in all three test animals 1 hour after removal of the gauze containing the benzene sulfonate solution .
At 2000 mg/L, very slight erythema (Draize Score 1) was observed in two of the three test animals 1 hour after removal of the benzene sulfonate solution. The irritation was reversed by 24 hours. No erythema or edema was observed in any test animals at this dosage at 24, 48 or 72 hours.
Since the effects at all dose levels were fully reversible within 72 hours, Sodium Benzene sulfonate can be considered not irritating to rabbit skin.

Executive summary:

A Skin irritation study was performed on New Zealand White rabbits to assess the irritation potential of sodium Benzene sulfonate. The study was performed according to EPA OPPTS 870.2500, “Acute Dermal Irritation” Guidelines.Four doses were applied: 5000 mg/L, 2000 mg/L, 1000 mg/L, and 500 mg/l to 6 male and 6 female rabbits per dose group. The pH of the 1000 mg/L dosage was 7.01 and 6.98 prior to dosing and after the 4-hour exposure, respectively. For the 5000 mg/L dosage, the pH was 7.00 and 7.02 prior to dosing and after the 4-hour exposure, respectively.

Each dose of test compound (0.5 ml of each concentration for each dose cohort) was applied to a small area of skin (approximately 6cm2) and covered with four layers of gauze patch held in place with nonirritating tape. Since the compound was in liquid form, it was applied to the gauze before application to the skin. The patch was loosely held in contact with the skin using a semi-occlusive dressing for the exposure period of 4 hours.

At the end of the 4-hour exposure period, the patches were removed and the skin wiped to remove any test substance still remaining. Animals were observed for signs of erythema and edema at 1, 24, 48, and 72 hours after patch removal. Observations of erythema or edema were scored according to the Draize Scale for Scoring Skin Reactions (USEPA 1998). This scale assesses irritation as follows: 0, no erythema or edema; 1, very slight erythema and/or edema (barely perceptible); 2, well-defined erythema and/or slight edema; 3, moderate to severe erythema or moderate edema, and 4, severe erythema and/or edema. Animals were weighed before exposure and at the end of the exposure period (day 3) and observed daily for the incidence of any clinical signs of toxicity (other than erythema and edema). Control skin showed no signs of irritation.

At a dose of 5000 mg/L, very slight erythema (Draize Score 1) was observed in all three test animals 1 hour after removal of the gauze containing the benzene sulfonate solution.

At the 24-hour observation point, very slight irritation (Draize Score 1) was observed in one of the three test animals. At the 48- and 72-hour observation points, the irritation was reversed, and no irritation was observed in any of the animals. Edema was not observed at any time. Control skin showed no signs of irritation. At 2000 mg/L, very slight erythema (Draize Score 1) was observed in two of the three test animals 1 hour after removal of the benzene sulfonate solution. The irritation was reversed by 24 hours. No erythema was observed in any test animals at this dosage at 24, 48 or 72 hours.

 

Since the effects at all dose levels were fully reversible within 72 hours, Sodium Benzene sulfonate can be considered not irritating to rabbit skin.