Butanedioic acid, 2-sulfo-, 1(or 4)-[2-(C12-18 and C18-unsatd. amido)ethyl] 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:

1962

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basis scientific principles, however the method does not comply to current requirements on limited details were available on materials and methods.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

4 animals tested and evaluated after 48h and 5 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts

IUPAC Name:

Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts

Test material form:

other: liquid

Test animals

Species:

human

Strain:

not specified

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Type of coverage:

occlusive

Preparation of test site:

other: swabbing with warm distilled water and dried

Vehicle:

other: neutral distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A 1 cm2 of unmedicated white lint was soaked in the test solution, lightly blotted and applied to the skin.
- Concentration (if solution): Solutions were made in neutral distilled water so that in each instance the “active matter” content was maintained at levels of 5% and 10% for each test substance.

Duration of treatment / exposure:

48 hours

Observation period:

72 hours

Number of animals:

4 volunteers per test substance

Details on study design:

TEST SITE
- Area of exposure: outer surface of the left upper arm
- Type of wrap if used: waterproof adhesive dressing of some 4.5 cm diameter, the adhesive centre portion of which was covered with a circle of cellulose film of 2.2 cm diameter.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: individual scores

Time point:

other: 48 hours & 5 days

Score:

0

Irritant / corrosive response data:

No reactions were detected.

Any other information on results incl. tables

Table 1. Irritation

Subject	5% solution		10% solution
	48 hours	5 days	48 hours	5 days
102	-	-	-	-
103	-	-	-	-
104	-	-	-	-
105	-	-	-	-
Result-No reaction detected

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

No reactions were detected.

Executive summary:

A 1 cm2 of unmedicated white lint was soaked in the 5 and 10% test substance solution in comparison with toilet soaps, and applied to the skin of the left arm of 4 volunteers for 48 hours under waterproof adhesive dressing, followed by an observation period of 72 hours. No reactions were detected.