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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)

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)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
8-sec-Butyl-5,6,7,8-tetrahydroquinoline
EC Number:
938-871-2
Molecular formula:
C13H19N
IUPAC Name:
8-sec-Butyl-5,6,7,8-tetrahydroquinoline

In vivo test system

Test animals

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

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 25%
No. of animals per dose:
5

Results and discussion

Any other information on results incl. tables

Table 2: Calculation of Stimulation Indices per Dose Group Group Calculation Test item concentration Mean DPM per animal (2 lymph nodes) a) SD S.I. Vehicle Control Group for the Test Item (acetone:olive oil (4+1 (v/v))) 479.3 79.3 1.00 5% GR-50-0572 1295.7 b) 258.3 2.70 10% GR-50-0572 1940.1 b) 503.8 4.05 25% GR-50-0572 5208.3 b) 925.6 10.87 Positive Control Group (25% X -HCA) 5160.1 b) 2268.0 10.77 a) Mean DPM/animal was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group (5 animals) b) Statistically significant increase in comparison to the control group (p

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study the test item GR-50-0572 dissolved in acetone:olive oil (4+1 (v/v)) 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 highest concentration tested was the highest concentration
that could be applied whilst avoiding systemic toxicity and excessive local skin irritation as
confirmed by two pre-experiments.
The animals did not show any signs of systemic toxicity or local skin irritation during the
course of the study and no cases of mortality were observed. A statistically significant
increase in ear weight was observed in the positive control group. For the measured ear
thickness, this was not observed. For the test groups, neither the measured ear weights
nor the ear thickness showed a statistically significant or biologically relevant increase in
comparison to the vehicle control group.
In this study Stimulation Indices (S.I.) of 2.70, 4.05, and 10.87 were determined with the
test item at concentrations of 5, 10, and 25% (w/w) in acetone:olive oil (4+1 (v/v)),
respectively. A statistically significant increase was observed in comparison to the vehicle
control group (p<0.05) and a clear dose response was obtained.
An outlier was identified in the vehicle control group and in the high dose group (DPM
value determined for animals number 2 and 19). However, as exclusion of the outliers did
not have an influence on the overall test result, the values in question were not excluded
from calculation.
The S.I. determined with the positive control was 10.77, demonstrating the validity of the
study.
The test item GR-50-0572 was found to be a skin sensitiser and an EC3 value of
6.1% (w/w) was derived.