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EC number: 946-533-0
CAS number: -
PRELIMINARY IRRITATION STUDY
No irritation was observed in any of the
animals examined. The results of the epidermal exposures for the
selection of highest test substance concentration to be tested in the
main study are described in the table. Based on the results, the highest
test substance concentration selected for the main study was a 100%
- Skin reactions/Irritation:
No skin reactions were observed in any of the animals examined.
- Macroscopy of the auricular lymph nodes
and surrounding area: The majority of nodes were considered normal in
size, except for enlarged nodes of two animals at 50% and two animals at
100%. No macroscopic abnormalities of the surrounding area were noted.
- Body weights: Body weights and body weight
gain of experimental animals remained in the same range as controls over
- Toxicity and Mortality: No mortality
occurred and no symptoms of systemic toxicity were observed in the
animals of the main study.
In a local lymph node assay according
to OECD guideline 429 (2002) and EU
Method B.42 (2004) Amphopropionate C8 dissolved in
dimethylformamide was assessed for its possible contact allergenic
potential using test item concentrations of 25, 50 and 100%.
The animals did not show any clinical
signs during the course of the study and no cases of mortality were
In this study Stimulation Indices
(S.I.) of 1.9, 6.8, and 8.5 were determined with the test item at
concentrations of 25, 50, and 100% in dimethylformamide, respectively.
These results indicate that the test substance could elicit an SI ≥ 3
and Amphopropionate C8 is therefore regarded as skin sensitiser under
the conditions of this study. The data showed a dose-response and an EC3
value of 30.6% was calculated.
Based on these results Amphopropionate C8
is classified as Category 1B based on CLP, EU GHS (Regulation (EC) No
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