Registration Dossier

Administrative data

Description of key information

Irritation / corrosion:
- skin: not irritating;
- eyes: not irritating;

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

Skin irritation by stearic acid was evaluated in a study performed in accordance with federal guidelines (International Bio-Research, 1974). 0.5 mL of stearic acid was applied to the abraded skin of 6 New Zealand White rabbits under occlusion for 24 hours.at 24 and 72 hours after application revealed no signs of irritation. Although a longer application under occlusion than suggested according to actual guidelines, the resulting scores are 0, both for erythema and edema, respectively. Based on this, stearic acid can be regarded as not irritating to skin.

 

Eye

In a published study performed according to national guidelines, stearic acid was instilled into the eyes of six rabbits (Briggs et al., 1976). Mild conjunctival erythema was found in 2 animals at 24 and 48 hours while all signs of irritation hat subsided completely in 72 hours. Thus, a mean score of 0.2 for conjunctival erythema could be

Justification for classification or non-classification

The substance may contain few of lauric acid (C12), which is classified as R41/eye damage Cat 1. The specific concentration limit for the lauric acid is established as 70% based on a reliable experimental data. According to DPD (1999/45/EC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, stearic acid dose not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint, as the concentration of C12 is lower than 70%.