Reaction Product of Ca(OH)2, MgO and Tall Oil Pitch

Endpoint summary

Description of key information

Based on the available data from in vitro investigations Ca/Mg-salt of Tall OIL Pitch (TOP) has no skin irritant properties and is predicted as non-irritant in the human Corneal Epithelial model. Results obtained from tests using Tall-Oil Pitch supported these findings as Tall-Oil Pitch is not irritating to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

SKIN CORROSION / IRRITATION

An in-vitro study for predicting non-specific, corrosive potential of Ca/Mg-salt of Tall Oil Pitch (TOP) by using reconstructed human skin (RHS) EST-1000 in accordance with OECD TG 431 and with an EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion).

Ca/Mg-salt of Tall Oil Pitch (TOP) was tested undissolved (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin) and an incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 94% and 79 % (rounded), respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used (Bayer Pharma AG 2011).

The study which allows the hazard identification of irritant substances in accordance with GHS category 2, was performed in 2011. The experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).

Undissolved Ca/Mg-salt of Tall Oil Pitch (TOP) was applied topically to the RHS model, i.e. 30 mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 85 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.

Thus, the results show that Ca/Mg-salt of Tall Oil Pitch (TOP) is considered to have no skin irritation category. (Bayer Phaerma AG 2011).

EYE IRRITATION

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undisolved Ca/Mg-salt of Tall Oil Pitch (TOP) was applied topically to the HCE tissue, i.e. 30 mg per insert (three replicates). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 99 % (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Ca/Mg-salt of Tall Oil Pitch (TOP) is predicted as non-irritant under the conditions of this test method (Bayer Pharma AG 2011).

Justification for classification or non-classification

Based on the available data no classification or labelling is required.