Butanedioic acid, sulfo-, 4-C12-14 (even numbered)-alkyl esters, disodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1991

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: The test method does not follow the internationally accepted test methods. Data on test substance identification, test organism and results were limited.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The methylene blue method quantifies the tensioactive skin effect. The larger the tensio-active effect, the more methylene blue is absorbed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid, sulfo-, 4-C12-14 (even numbered) -alkyl esters, disodium salts

IUPAC Name:

Butanedioic acid, sulfo-, 4-C12-14 (even numbered) -alkyl esters, disodium salts

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): [Trade name]

Test animals

Species:

human

Details on test animals or test system and environmental conditions:

20 test persons (19 females and 1 male) between 33 and 56 years of age. They had not used cosmetics during 3 days before the test.
ENVIRONMENTAL CONDITIONS (acclimatisation for 30 minutes before start of the test):
- Temperature (°C): 22
- Humidity (%): 60.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other (untreated) arm

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10mL
- Concentration (if solution): 2%

Duration of treatment / exposure:

15 min

Number of animals:

20

Details on study design:

TEST SITE
- Area of exposure: inside of forearm
- % coverage: Not provided
- Type of wrap if used: gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 500mL lukewarm water
- Time after start of exposure: 15 min

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: extinction data x100

Basis:

mean

Score:

163.49

Remarks on result:

other: test item

Results 2

Irritation parameter:

other: extinction data x 100

Basis:

mean

Score:

166.03

Remarks on result:

other: Na-Lauryl (positive control)

Results 3

Irritation parameter:

other: extinction data x 100

Basis:

mean

Score:

38.83

Remarks on result:

other: negative control

Irritant / corrosive response data:

Extinction data x 100 (mean):
- [Trade name]: 163.49
- Na-lauryl (+ control): 166.03
- Negative control: 38.83

Applicant's summary and conclusion

Interpretation of results:

other: irritating

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The test item shows a strong roughening effect and is therefore classified in the category significantly roughening. The test item in this test turns out to do only slightly better than sodium lauryl sulphate.

Executive summary:

In a human test 20 test persons (19 females and 1 male) between 33 and 56 years of age (that had not used cosmetics during 3 days before the test), were exposed on the forearms for 24 hours to the test item under gauze occlusion, followed by methylene blue exposure to measure tensio-active effect (Bielfeldt S., Schrader K., 1991). The test formulation showed a strong roughening effect. The test item in this test turned out to do only slightly better than sodium lauryl sulphate. The test method is not a regulatory standard method for skin irritation.