Sodium benzenesulphinate

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 Journal

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 disodium Benzene meta-disulfonate

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium benzene-1,3-disulphonate

EC Number:

212-606-4

EC Name:

Disodium benzene-1,3-disulphonate

Cas Number:

831-59-4

Molecular formula:

C6H6O6S2.2Na

IUPAC Name:

disodium benzene-1,3-disulfonate

Test material form:

solid: granular

Details on test material:

- Name of test material (as cited in study report): benzene meta-disulfonate
- Molecular formula : C6H6O6S2.2Na
- Molecular weight : 282.204 g/mol
- Smiles notation: S(=O)(=O)([O-])c1cc(S(=O)(=O)[O-])ccc1.[Na+].[Na+]
- InChl : 1S/C6H6O6S2.2Na/c7-13(8,9)5-2-1-3-6(4-5)14(10,11)12;;/h1-4H,(H,7,8,9)(H,10,11,12);;/q;2*+1/p-2
- Substance type: Organic
- Physical state: Solid
-Purity:Pure compound

Specific details on test material used for the study:

- Name of test material (as cited in study report): disodium benzene meta-disulfonate
- Molecular formula : C6H6O6S2.2Na
- Molecular weight : 282.204 g/mol
- Smiles notation: S(=O)(=O)([O-])c1cc(S(=O)(=O)[O-])ccc1.[Na+].[Na+]
- Lot number: G6341A
- InChl : 1S/C6H6O6S2.2Na/c7-13(8,9)5-2-1-3-6(4-5)14(10,11)12;;/h1-4H,(H,7,8,9)(H,10,11,12);;/q;2*+1/p-2
- Substance type: Organic
- Physical state: Solid
-Purity:Pure compound

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:

5000 and 2000 mg/L

Duration of treatment / exposure:

4-hrs.

Observation period:

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

Number of animals:

Total: 12
5000 mg/L: 3 Male and 3 female
2000 mg/L: 3 Male and 3 female

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 vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1,24,48,72 hrs

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: At dose concentration 2000 mg/l

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1,24,48,72 hrs

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: At dose concentration 2000 mg/l

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hr.

Score:

3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: At dose concentration 5000 mg/l

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hrs.

Score:

2

Max. score:

4

Reversibility:

no data

Remarks on result:

other: At dose concentration 5000 mg/l

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hrs.

Score:

1

Max. score:

4

Reversibility:

no data

Remarks on result:

other: At dose concentration 5000 mg/l

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hrs.

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: At dose concentration 5000 mg/l

Irritant / corrosive response data:

Control skin showed no signs of irritation.Irritation was completely reversible within 72 hours.

Other effects:

An increase in the body weight of the animals dosed 5000 and 2000 mg/L test material was observed. No signs of toxicity were noted.

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 meta-disulphonate	5000	3	2.17±0.038	2.23±0.053	0.06±0.015	none
Benzene meta-disulphonate	2000	3	2.16±0.075	2.20±0.075	0.04±0.012	none

 

a-     

b-     

c-      

Table 2: Summary of irritation tests for benzene meta-disulphonate                                      

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 2 of 3 animals
48		Very slight erythema in 1 of 3 animals
72		None observed
Conclusion		Slight irritant reversible in 72 hours
1	2000	None observed
24		None observed
48		None observed
72		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 5000 mg/L, very slight (one animal, Draize Score 1) and well defined erythema (two animals, Draize Score 2) were observed 1 hour after removal of the test substance. At the 24-hour observation point, only two animals demonstrated very slight irritation. By 48 hours, very slight irritation remained on only one of the two test animals. By 72 hours, no irritation was observed on any animal.
No erythema or edema was observed in any test animals at 2000 mg/L.
Since the effects at 5000mg/l were fully reversible within 72 hours and not observed at 2000 mg/l, disodium Benzene meta-disulfonate 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 disodiumBenzenemeta-disulfonate. The study was performed according to EPAOPPTS 870.2500, “Acute Dermal Irritation” Guidelines.

Two concentrations of disodium benzene meta-disulfonate were tested in separate groups of animals, 3 female and 3 male rabbits: 5000 and 2000 mg/L. The pH of the 5000 mg/L test substance ranged from 7.07 to 6.22 prior to dosing and after the 4-hour exposure. The pH of the 2000 mg/L test substances, measured prior to dosing and after the 4-hour exposure, ranged from 7.04 to 6.96.

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 5000 mg/L, very slight (one animal, Draize Score 1) and well defined erythema (two animals, Draize Score 2) were observed 1 hour after removal of the test substance. At the 24-hour observation point, only two animals demonstrated very slight irritation. By 48 hours, very slight irritation remained on only one of the two test animals. By 72 hours, no irritation was observed on any animal. No erythema or edema was observed in any test animals at 2000 mg/L.

 

Since the effects at 5000mg/l were fully reversible within 72 hours and not observed at 2000 mg/l,disodium Benzenemeta-disulfonate can be considered not irritating to rabbit skin.