Registration Dossier

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:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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)

Resultsopen allclose all
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.
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.