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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Irritation / corrosion:
- skin: not irritating (OECD 404; Analogy CAS 57-11-4);
- eye: not irritating (OECD 405; Analogy CAS 57-11-4);

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

Due to lack of reliable data with fatty acids C16-22 on skin irritation, a study with one of the main constituents of fatty acids C16-22, C18 fatty acid (stearic acid) is used for the hazard assessment. Moreover, fatty acids C16-22 and C18 fatty acid (stearic acid) belong to the same category based on structural and toxicological properties. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

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.

Since stearic acid is a main constituent of fatty acids C16-22 and both substances belong to the same category based on structural and toxicologicall properties, the same result can be expected for fatty acids C16-22. Thus, it is not irritating to skin.

 

 

Eye

Due to lack of reliable data with fatty acids C16-22 on skin irritation, a study with one of the main constituent of fatty acids C16-22, C18 fatty acid (stearic acid) is used for the hazard assessment. Moreover, fatty acids C16-22 and C18 fatty acid (stearic acid) belong to the same category based on structural and toxicological properties. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

 

In a published study performed according to national guidelines, stearic acid was instilled into the eyes of six rabbits (Briggs, G.B., 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 calculated. Based on the results, stearic acid can be regarded as not irritating to eyes.

Since stearic acid is a main constituent of with fatty acids C16-22 and both substances belong to the same category based on structural and toxicological properties, the same result can be expected for fatty acids C16-22. Thus, it is not irritating to eyes.

Justification for classification or non-classification

Fatty acids C16-22 do not contain any components, which are classified as as irritant on skin or as seriously damaging to the eye. According to DPD (1999/45/EC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, fatty acids C16-22 do not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint.