Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

Not specified in report.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: MAFF Primary Dermal Irritation Study, 1985. EEC Methods Number B.4 Dermal Irritation 19 Sept 1988.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-430-6

EC Name:

-

Cas Number:

65143-89-7

Molecular formula:

UVCB

IUPAC Name:

Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt

Test material form:

other: aqueous solution

Details on test material:

Test material: Dowfax 8390
Reference: lot# 68364M960202-1-2
10% aqueous material as diluted by the sponsor
Source: DPO/HTF/Surfactants, Larkin Lab, The Dow Chemical Company
Appearance: clear liquid
pH: ~9

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The dermal irritation study was conducted on male and female New Zealand White rabbits which weighed from 2.030 to 2.359 kg, at study start, and were obtained from Covance Research Products, Inc., Denver, PA. Rabbits were born on April 12, 1997; dosed on July 22, 1997 and the study was terminated on July 28, 1997. Upon arrival to the laboratory, the animals were examined for health status by the laboratory veterinarian. All rabbits were acclimated to the laboratory environment for at least two weeks prior to study start. Animals were identified by a uniquely numbered metal eartag. Animals were housed individually in animal care facilities fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International. The animal rooms of the testing facility were designed to maintain adequate environmental conditions concerning temperature, humidity, photocycle and air exchanges. The relative humidity was maintained within a range of 40-60%, for rabbits. The building alarm system was set to
activate if relative humidity went below 39% or above 61%. The room temperature was maintained at 19±3°C, for rabbits. The building alarm system was set to activate if the temperature went below 16°C or above 22°C. A 12 hour light/dark photocycle was maintained for all animal rooms with lights on at 7:00 a.m. and off at 7:00 p.m. Room air was exchanged 15 times/hour, and the water lines automatically bled every six hours. Animals received approximately four ounces of Certified LabDiet #5322 (PMI Feeds, St. Louis, MO) per day. Tap water from the municipal water supply was supplied ad libitum. Water and feed analyses were performed as stated in the Standard Operating Procedures of The Toxicology Research Laboratory. No contaminants were found which would have affected the integrity of the study. Copies of the results of these analyses are maintained in the Toxicology Research Laboratory. Routine monitoring on weekends was limited to animal husbandry procedures required to ensure the availability of feed and water.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

The application sites were graded for erythema and edema within thirty minutes, 24, 48 and 72 hours, and when necessary, at 7 days after test
material removal.

Number of animals:

9/sex/application (3/sex were dosed with Dowfax 8390, STEOL CS-370 or VISTA C-550 SLURRY)

Details on study design:

The day prior to study start, an area approximately 10 cm x 10 cm of the back, of nine male and nine female New Zealand White rabbits, was clipped free of fur. On test day 1, a 0.5 ml aliquot of each respective test material was applied to an intact site on the backs of six rabbits per test material and covered with a gauze patch with cotton backing. The gauze patch was held in place with an elastic rabbit jacket. The jacket and patch were
removed after four hours and the back was wiped with a damp disposable towel to remove any residual test substance. The application sites were graded for erythema and edema within thirty minutes, 24, 48 and 72 hours, and when necessary, at 7 days after test material removal. Animals were weighed on the day of treatment and at study termination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: within 30 minutes, 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: within 30 minutes, 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

There were no signs of dermal irritation of the test site in any of the six rabbits that were dosed with DOWFAX 8390. The rabbits administered
DOWFAX 8390 were terminated after 72 hours.

Other effects:

Dermal application of Dowfax 8390 did not have any effect on body weight.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

other: not classifiable

Remarks:

Criteria used for interpretation of results: other: EU GHS

Conclusions:

There were no signs of dermal irritation of the test site in any of the six rabbits that were dosed with DOWFAX 8390.

Executive summary:

DOWFAX* 8390, lot #68364M960202-1-2, was evaluated for primary dermal irritation. Aliquots of 0.5 ml of the test material (10% aqueous materials as diluted by the sponsor) were applied for four hours to the intact skin on the backs of groups of six New Zealand White rabbits per test material. There were no signs of dermal irritation of the test site in any of the six rabbits that were dosed with DOWFAX 8390. The rabbits administered DOWFAX 8390 were terminated after 72 hours. . There was no effect on the body weights of the rabbits.

*Trademark of The Dow Chemical Company