Acid D,L-aspart

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acid D,L-aspart

EC Number:

210-513-3

EC Name:

Acid D,L-aspart

Cas Number:

617-45-8

Molecular formula:

C4H7NO4

IUPAC Name:

aspartic acid

Details on test material:

Test item D,L-aspartic acid
Alternative name D,L-aszparaginsav cfn. 100% Hat.
Batch No. S27170N
Physical state Solid
Loss on drying 13.5%
Active ingredient in dry substance 98.3%
Chloride ion 200 μg / g
Manufacturing date 20 July 2012
Expiry date 18 Month
Storage 15-30°C

Results and discussion

Any other information on results incl. tables

Disks of EPISKIN (three units / chemical) were treated with test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls respectively. For each treated tissue viability was expressed as a percentage relative to negative control. The test item is considered to be irritant to skin, if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control (mean value: 81 %). All obtained test item viability results were above 50 % when compared to the viability values obtained from the negative control, therefore the test item was considered to be non-irritant to skin. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

In this in vitro skin irritation test in the EPISKIN model with test item D,L-aspartic acid the results indicated that the test item is Non Irritant (NI) [UN GHS: No Category].

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In this in vitro skin irritation test in the EPISKIN model with test item D,L-aspartic acid the results indicated that the test item is Non Irritant (NI) [UN GHS: No Category].