Acid D,L-aspart

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

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 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

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

Test material form:

solid: crystalline

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: 20 January 2014
Storage: 15-30 °C
Dose correction factor: 1.176

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

other: aqueous 1 % Pluronic®PE 9200

Concentration:

0,5%

No. of animals per dose:

4

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

The stimulation index (SI = the DPN of a treated (positive control or test item) group divided by the DPN of the respective negative control group) for each treatment group was also calculated. A stimulation index of 3 or greater is an indication of a positive result. Based on the results EC3 value (dose calculated to induce a stimulation index of 3) of the test item could not be calculated.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

DPM (disintegration per minute) was measured for each treatment group. The measured DPM values were corrected with the background DPM value. The average of the two measured DPM values of 5 % (w/v) TCA solutions was used as the background DPM value. The results were expressed as DPN (DPM divided by the number of pooled lymph nodes).

Any other information on results incl. tables

Test Group Name	MeasuredDPM/group	Group*DPM	DPN(DPM/Node)	Stimulation Index Values
Negative (vehicle) control: for the Positive control: AOO	9329	9256.5	1157.1	1.0
Positive control: 25 % HCA in AOO	85719	85646.5	10705.8	9.3
0,5 % (4.25 mg/mL active ingredient) D,L-aspartic acid in aqueous 1% Pluronic	6709	6636.5	829.6	1.0
0.25 % (2.125 mg/mL active ingredient) D,L-aspartic acid in aqueous 1% Pluronic	5255	5182.5	647.8	0.8
0.1 % (0.85 mg/mL active ingredient) D,L-aspartic acid in aqueous 1% Pluronic	2480	2407.5	300.9	0.4
Negative (vehicle) control: for the Tes Item: aqueous 1% Pluronic	6602	6529.5	816.2	1.0

*Group DPM = measured DPM group- average DPM background

Average DPM background = 72.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

In conclusion, under the conditions of the present Local Lymph Node Assay, D,L-aspartic acid tested at the maximum attainable concentration of 0.5% (4.25 mg /mL active ingredient) based on solubility and at concentrations of 0.25 % and 0.1 % (2.125 mg /mL or 0.85 mg /mL active ingredient) as formulations in an appropriate vehicle (aqueous 1% Pluronic) was shown to have no sensitization potential.