Registration Dossier
Registration Dossier
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EC number: 200-313-4 | CAS number: 57-11-4
Endpoint summary
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%.
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