Benzenesulfonic acid, para-, monoalkylation products with C14-C18 branched olefins (C15 rich) derived from propene oligomerization, calcium salt, overbased including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted to guidelines and GLP and is considered reliable without restriction for assessment of the test material. Because teh study is being used for read-across to a similar material, the reliability is reduced to reliable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

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: room temperature and humidity
- Other: Brown liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour 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/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled 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: 24h/48h/72h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Remarks:

Animal 2

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Remarks:

Animal 3

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Remarks:

Animal 1

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Remarks:

Animal 2

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Remarks:

Animal 3

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.

Other effects:

Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.

Any other information on results incl. tables

Table 1: 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: 4	Max. score: 2
60 min	1/0/1	0/0/1
24 h	1/0/1	0/0/1
48 h	1/0/2	0/0/1
72 h	0/0/2	0/0/1
Average 24h, 48h, 72h	0.7/1/0.7	0.3/0.3/0.3
Reversibility*)	c/c/c	c/c/c
Average time (unit) for reversion	72/0/14d	0/0/14d

 

*) 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

Executive summary:

In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of sodium 4-icosylbenzenesulfonate for 4 hours.  Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

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