#607 Dermal sensitization
Objective of the study
The study should provide information to assess the potential of the pesticide to provoke skin sensitization reactions.
Circumstances under which the study is recommended to be required
The dermal sensitization study is recommended if repeated dermal exposure is likely under conditions of use.
The study is normally not required if the pesticide is corrosive to skin or has a pH of < 2 or > 11.5.
If an active ingredient is identified as a skin sensitizer, it can potentially induce a hypersensitivity reaction. Therefore, potential respiratory sensitisation should be taken into account when appropriate tests are available or when there are indications of respiratory sensitisation effects.
Test organism
The local lymph node assay (LLNA) study is conducted in mice. The conventional study is conducted in guinea pig.
Test substance
- Technical grade active ingredient
- Formulated product
Typical endpoints of the study
LLNA: Proliferation of lymphocytes in the lymph nodes is assessed. Conventional test: Skin reaction (e.g. erythema) is assessed. In chemico: protein reactivity is assessed; In vitro method: luciferase gene induction is assessed.
Test guidelines
The following test guidelines may be used for determination dermal irritation:
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OECD Guidelines for the Testing of Chemicals. Test No. 429: Skin Sensitization: Local Lymph Node Assay.
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OECD Guidelines for the Testing of Chemicals. Test No. 406: Skin Sensitization
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OECD Guidelines for the Testing of Chemicals. Test No. 442: Skin Sensitization: Local Lymph Node Assay: 442A: DA 442B: BrdU-ELISA;
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OECD Guidelines for the Testing of Chemicals. Test No. 442C: In Chemico Skin Sensitisation. Direct Peptide Reactivity Assay (DPRA).
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OECD Guidelines for the Testing of Chemicals. Test No. 442D: In Vitro Skin Sensitisation. ARE-Nrf2 Luciferase Test Method.
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US EPA Health Effects Test Guidelines. OPPTS 870.2600 Skin sensitization
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EC Testing Method B.6. Skin sensitisation. Council Regulation (EC) No 440/2008).