Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Positive results in LN weight and LN cell count together with negative irritatiton effect (ear weight) and no clinical symptoms of systemic toxicity revealed that the test substance, Humic acids, sodium salts, is weak contact allergen in mice.

For the discussion about the skin sensitivity of the substance - Humic acids, sodium salts - three aspects were took into consideration. 

- The results of the alternative sensitivity test

The test was performed according to the EU method B.42 with modifications as described in publications of Ulrich P, Streich J, Suter W, 2001; Ehling et al., 2005; Ehling et al., 2005A (non Radioactive measuring of cell proliferation).

Positive results in LN weight and LN cell count together with negative irritatiton effect (ear weight) and no clinical symptoms of systemic toxicity revealed that the test substance is weak contact allergen in mice.

 - Although no epidemiological study was performed, the workers incoming in the contact with the substance for a long time never had the experience with allergy to this substance.  

 - The structurally very similar substance – Humic acids, potassium salts – was tested by the same test - and negative result on the skin sensitisation was found out.

Note: The registrant is owner of the LLNA studies of both substances (Humic acids, sodium salts and Humic acids, potassium salts - CAS No.: 68514-28-3, EC No.: 271-030-1).

To resolve about the skin sensitivity of the substance is very difficult.

For the confirmation of sensibilization effect the other test (in vivo) should be performed.

 


Migrated from Short description of key information:
EU method B.42 with modifications as described in publications of Ulrich P, Streich J, Suter W, 2001; Ehling et al., 2005; Ehling et al., 2005A.
(non Radioactive measuring of cell proliferation).
GLP study

Justification for classification or non-classification

The substance is not classified as skin senzitizing substance - see section Discussion skin sensitisation above.