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Skin sensitisation

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Administrative data

skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (missing positive control)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
missing positive control treatment
GLP compliance:
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol, ethoxylated, esters with acrylic acid
EC Number:
EC Name:
Glycerol, ethoxylated, esters with acrylic acid
Cas Number:
Molecular formula:
UVCB substance
Glycerol, ethoxylated, esters with acrylic acid
Details on test material:
- Name of test material (as cited in study report): Glycerin3EOTA
- Lot/batch No.: GK0561/1128

In vivo test system

Test animals

other: CBA/Ca
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Details on study design:
1st application: Induction 1 % open epicutaneous

Study design: in vivo (LLNA)

other: acetone
In the first step concentrations of 1, 3 and 10% of the test substance in acetone were used. As
Iymph fade reactions and increases in ear weight were produced by all concentrations, in the second step concentrations of 0.1, 0.3 and 1 % were examined in order to determine a concentration not inducing lymph node reactions.
No. of animals per dose:
6 females
Details on study design:
Each test animal was applied with 25 µl per ear of the respective test substance preparation to the dorsum of both ears tor three consecutive days. The control group was treated with 25 µl per ear of the vehicle alone.
Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the cellular content (indicator of cell proliferation) and weight of each animal's pooled Iymph nodes. Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and tor each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin Irritation. In addition the body weight change over the study period was determined.
The statistical evaluations were performed using the WILCOXON-test ( # for p <= 0.05, ## for p <= 0.01).

Results and discussion

In vivo (LLNA)

Remarks on result:
other: EC1.5 (ear weight) >1% <3% EC1.5 (cell count) >0.3% <1%

Any other information on results incl. tables

Lymph Node Weight
Treatment mean (mg) Index Significance
vehicle 5.4 1.00  
vehicle 5.1 1.00  
0.1% 5.3 1.05  
0.3% 5.9 1.17 ##
1% 7 1.38 #
1% 7.6 1.41 ##
3% 10.5 1.95 ##
10% 11.9 2.20 ##
Cell Count
Treatment mean (counts/lymph node pair) Index Significance
vehicle 9,790 1.00  
vehicle 10,101 1.00  
0.1% 10,805 1.07  
0.3% 11,706 1.16  
1% 15,351 1.52 #
1% 17,096 1.75 ##
3% 23,836 2.43 ##
10% 32,162 3.29 ##

No signs of systemic toxicity were noticed. The test substance induced a statistically significant and biologically relevant proliferation of the auricular lymph nodes and cell counts when applied as 1, 3 and 10% test substance preparation in acetone to the ear of the mice. A statistically significant increase in lymph node weights but not in lymph node cellularity was observed at the test substance concentration of 0.3%. The increased ear weights (6 to 38% in the treatments 1 to 10%) and clinical signs of skin irritation (incrustation in 5 animals, scaling in 1 animal applied with the 10% test substance preparation and incrustation in 1 animal applied with the 3% test substance preparation) indicated a significant irritant property of the test substance at concentrations of 1%, 3% and 10%.

Applicant's summary and conclusion

Interpretation of results:
Migrated information