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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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:
other: Solid, powder, yellow
Details on test material:
Identification: Macrolex Gelb G
CAS-No.: 17772-51-9
EC-No.: 241-753-7
Chemical Name: 3-Hydroxy-2-(3-hydroxy-2-quinolinyl)-1 H-inden-1-one
Appearance: Solid, powder, yellow
Purity: 99.1 (weight %)
Dose calculation was not adjusted to purity.

In vivo test system

Test animals

Species:
mouse
Strain:
other: Mice, CBA/CaOlaHsd
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used, was a 25% suspension in propylene glycol. Vortexing of the test item was used to formulate the test item.

Thus, the test item in the main study was assayed at 5, 10, and 25% (w/w). The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Test item concentration Mean DPM per animal (2 lymph nodes) a) SD S.I. Vehicle Control Group (PG) 1113.5 321.3 1.00 5% Macrolex Gelb G 6273.1 857.0 5.63 10% Macrolex Gelb G 6225.9 1228.1 5.59 25% Macrolex Gelb G 5079.3 1439.8 4.56
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Calculation and Results of Individual Data Vehicle: PG Test item concentration DPM values measured DPM-BG per animal (2 lymph nodes) a) S.I.b) % Group no. Animal no. --- --- BG I 17 --- --- --- --- BG II 20 --- --- 0 1 1 889 870.5 --- 0 1 2 977 958.5 --- 0 1 3 1153 1134.5 --- 0 1 4 1680 1661.5 --- 0 1 5 961 942.5 --- 5 2 6 6124 6105.5 5.5 5 2 7 5798 5779.5 5.2 5 2 8# 7775 7756.5 7.0 5 2 9 5628 5609.5 5.0 5 2 10 6133 6114.5 5.5 10 3 11 4900 4881.5 4.4 10 3 12 6416 6397.5 5.7 10 3 13 5278 5259.5 4.7 10 3 14 6616 6597.5 5.9 10 3 15 8012 7993.5 7.2 25 4 16 3566 3547.5 3.2 25 4 17 7283 7264.5 6.5 25 4 18 5680 5661.5 5.1 25 4 19 4296 4277.5 3.8 25 4 20 4664 4645.5 4.2 # = Outlier as detected by Dean-Dixon- and Grubb’s Test. The value in question (animal no. 8) was not excluded from the calculations, since exclusion of the outlier did not change the overall result. 1 = Control Group 2-4 = Test Group a) = values corrected for mean background value (BGI and BGII) b) = Stimulation Indices relative to the mean of the control group (Group 1)

Any other information on results incl. tables

Viability / Mortality

No deaths occurred during the study period.

Clinical Signs

The animals did not show any signs of local skin irritation during the course of the study and no cases of mortality were observed. On day 1, one animal (no. 14), treated with the test item concentration of 10%, showed a bulging eye (right side). The other animals of that test group and the animals treated with 5 and 25% test item concentration did not show any signs of systemic toxicity. Redness of the ear skin could not be observed, due to the colour of the test item.

Body Weights

The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Executive summary:

In the study the test item Macrolex Gelb G formulated in PG was assessed for its possible skin sensitising potential.

For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w).

The animals did not show any signs of local skin irritation during the course of the study and no cases of mortality were observed. On day 1, one animal (no. 14), treated with the test item concentration of 10%, showed a bulging eye (right side). The other animals of that test group and the animals treated with 5 and 25% test item concentration did not show any signs of systemic toxicity. Redness of the ear skin could not be observed, due to the colour of the test item.

In this study Stimulation Indices (S.I.) of 5.63, 5.59, and 4.56 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in PG, respectively.

The test item Macrolex Gelb G was found to be a skin sensitiser.