Docusate sodium

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Remarks:

3 short-term dermal studies in rabbits

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

before publication of 1962

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Amended Final Report on the Safety Assessment of Dioctyl sodium sulfosuccinate.

Author:

CIR (Cosmetic Ingredient Review)

Year:

1998

Bibliographic source:

International Journal of Toxicology, 147(Suppl. 4):1-20,1998.

Reference 2

Reference Type:

publication

Title:

Toxicological properties of several commercially available surfactants.

Author:

Olson, K. J., B. S. Dupree, E. T. Plomer, and V. K. Rowe.

Year:

1962

Bibliographic source:

J. Soc. Cosmet. Chem. 13:469-476.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

1) Heterogeneous-stock albino rabbits were shaved and abrasions were made to two areas of the caudal region of the belly. Cotton pads containing 5 mL of 1, 5, and 25% Dioctyl Sodium Sulfosuccinate were taped to the abraded areas. Dosed pads were replaced once a day for 3 days.
2) A similar experiment was conducted on two areas of intact rabbit skin; fresh applications of dosed pads were made 10 times in 14 days.
3) A third experiment was conducted on the intact skin of the external ear of a rabbit using the same concentrations of Dioctyl Sodium Sulfosuccinate in a similar application procedure.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Docusate sodium

EC Number:

209-406-4

EC Name:

Docusate sodium

Cas Number:

577-11-7

Molecular formula:

C20H38O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate

Test animals

Species:

rabbit

Strain:

other: Heterogeneous-stock albino rabbits

Sex:

not specified

Administration / exposure

Type of coverage:

other: Cotton pads containing 5 mL of 1, 5, and 25% Dioctyl Sodium Sulfosuccinate were taped to the exposed areas.

Vehicle:

not specified

Details on exposure:

TEST SITE
- Area of exposure:
Experiment 1: two shaved and abraded areas of the caudal region of the belly.
Experiment 2: two areas of intact rabbit skin.
Experiment 3: intact skin of the external ear of a rabbit
- Type of wrap if used: Cotton pads containing 5 mL of 1, 5, and 25% Dioctyl Sodium Sulfosuccinate were taped to the exposed areas.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL
- Concentration (if solution): 1, 5, and 25% Dioctyl Sodium Sulfosuccinate
- Constant volume or concentration used: yes

VEHICLE: not specified


USE OF RESTRAINERS FOR PREVENTING INGESTION: not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Experiment 1: 3 days
Experiment 2: 14 days
Experiment 3: 14 days

Frequency of treatment:

Experiment 1: once a day
Experiment 2: 10 times in 14 days
Experiment 3: 10 times in 14 days

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

5 other: mL of 1% Dioctyl Sodium Sulfosuccinate

Doses / concentrations 2

Dose / conc.:

5 other: mL of 5% Dioctyl Sodium Sulfosuccinate

Doses / concentrations 3

Dose / conc.:

5 other: mL of 25% Dioctyl Sodium Sulfosuccinate

No. of animals per sex per dose:

not specified

Control animals:

yes

Results and discussion

Any other information on results incl. tables

For the abdominal skin, the 1% solution had an index number of 4 (moderate hyperemia on intact skin, may or may not burn abraded skin), the 5% solution had an index of 5 (burn from two to four 24-hour applications to intact skin), and the 25% solution had an index of 6 (burn from one 24-hour application to intact skin). For the external ear, the 1% solution had an index number of 1 (essentially no irritation to intact skin), the 5% solution had an index of 4, and the 25% solution had an index of 6 (Olson et al. 1962).

 

Reference:

Olson, K. J., B. S. Dupree, E. T. Plomer, and V. K. Rowe. 1962. Toxicological properties of several commercially available surfactants. J. Soc. Cosmet. Chem. 13:469-476.

Applicant's summary and conclusion

Executive summary:

Heterogeneous-stock albino rabbits were shaved and abrasions were made to two areas of the caudal region of the belly. Cotton pads containing 5 mL of 1, 5, and 25% Dioctyl Sodium Sulfosuccinate were taped to the abraded areas. Dosed pads were replaced once a day for 3 days.

A similar experiment was conducted on two areas of intact rabbit skin; fresh applications of dosed pads were made 10 times in 14 days.

A third experiment was conducted on the intact skin of the external ear of a rabbit using the same concentrations of Dioctyl Sodium Sulfosuccinate in a similar application procedure.

For the abdominal skin, the 1% solution had an index number of 4 (moderate hyperemia on intact skin, may or may not burn abraded skin), the 5% solution had an index of 5 (burn from two to four 24-hour applications to intact skin), and the 25% solution had an index of 6 (burn from one 24-hour application to intact skin). For the external ear, the 1% solution had an index number of 1 (essentially no irritation to intact skin), the 5% solution had an index of 4, and the 25% solution had an index of 6 (Olson et al. 1962).

 

Reference:

Olson, K. J., B. S. Dupree, E. T. Plomer, and V. K. Rowe. 1962. Toxicological properties of several commercially available surfactants. J. Soc. Cosmet. Chem. 13:469-476.