Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts

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:

other: Study conducted to guidelines and GLP and reported fully.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

EC Number:

274-263-7

EC Name:

Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

Cas Number:

70024-69-0

IUPAC Name:

sodium 4-icosylbenzenesulfonate

Details on test material:

- Storage condition of test material: Ambient
- Other: Dark brown viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2071 to 2480 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): LabDiet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes, 24h, 48h, 72h and 8 days

Number of animals:

3/sex

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze binder.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with with paper towels moistened with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Animal 1

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Remarks:

Animal 2

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

erythema score

Remarks:

Animal 3

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

erythema score

Remarks:

Animal 4

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

erythema score

Remarks:

Animal 5

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 5 days

Results 6

Irritation parameter:

erythema score

Remarks:

Animal 6

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 7

Irritation parameter:

edema score

Remarks:

Animal 1

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 8

Irritation parameter:

edema score

Remarks:

Animal 2

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 9

Irritation parameter:

edema score

Remarks:

Animal 3

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 10

Irritation parameter:

edema score

Remarks:

Animal 4

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 11

Irritation parameter:

edema score

Remarks:

Animal 5

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

edema score

Remarks:

Animal 6

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Mean score calculated by average of results at 24h, and 72h for each animal.

Any other information on results incl. tables

Table 2: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility	Erythema	Oedema
	Max. score: 2	Max. score: 1
24 h	1/1/1/2/1/1	1/0/1/0/1/0
48 h	1/1/1/2/1/1	1/0/0/0/0/0
72h	1/1/1/1/1/1	1/0/0/0/0/0
Average 24h, 48h, 72h	1.2/1.2/1	0.5/0.2/0.2
Reversibility*)	c	c
Average time (unit) for reversion	7 days	48h

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mean scores for each animal at 24h, 48h and 72 h for erythema and oedema, respectively, were 0. Therefore, this substance is not irritating to skin under the conditions of this test.

Executive summary:

In a primary dermal irritation study, 6 young adult New Zealand white rabbits were dermally exposed to 0.5 mlof sodium 4-icosylbenzenesulfonate for 4hours.Animals then were observed for 8 days.

 

In this study, sodium 4-icosylbenzenesulfonate is not a dermal irritant.