citric acid, esters with dodecan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Principles of method if other than guideline:

Test substance was applied to preincubated skin models for 15 minutes. After rinsing the tissues were post-incubated . After this the viability was determined employing the MTT-Test.
In parallel to the experiment, the amount of LDH releaase into the culture medium was determined at different stages of the study: prior to test substance application, at the end of substance application and at the end of the post incubation period.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl hydrogen citrate

EC Number:

247-146-3

EC Name:

Didodecyl hydrogen citrate

Cas Number:

25637-88-1

Molecular formula:

C30H56O7

IUPAC Name:

didodecyl hydrogen citrate

Constituent 2

Reference substance name:

Tridodecyl 2-hydroxypropane-1,2,3-tricarboxylate

EC Number:

265-671-6

EC Name:

Tridodecyl 2-hydroxypropane-1,2,3-tricarboxylate

Cas Number:

65277-53-4

Molecular formula:

C42H80O7

IUPAC Name:

tridodecyl citrate

Constituent 3

Reference substance name:

Dodecyl dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

EC Number:

278-950-2

EC Name:

Dodecyl dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

Cas Number:

78568-45-3

Molecular formula:

C18H32O7

IUPAC Name:

2-[2-(dodecyloxy)-2-oxoethyl]-2-hydroxysuccinic acid

Test material form:

solid

In vitro test system

Test system:

human skin model

Cell type:

other: reconstituted human cornea epithelium models

Vehicle:

other: ultrapure water

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg of the test substance were applied and moistened with 25 µl ultrapure water.

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hour

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

104

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The endpoints LDH, viability and IL-1alpha release confirmed that the viable cell layers were not affected. Therefore the test item has to be classified as not irritant in terms of acute irritation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The endpoints LDH, viability and IL-1alpha release confirmed that the viable cell layers were not affected. Therefore the test item has to be classified as not irritant in terms of acute irritation.

Executive summary:

The endpoints LDH, viability and IL-1alpha release confirmed that the viable cell layers were not affected. Therefore the test item has to be classified as not irritant in terms of acute irritation.