Registration Dossier

Administrative data

Description of key information

Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates is not considered to possess skin or eye irritating properties.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

No information on skin irritation / corrosion of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates was identified. However, one study from a structural analogue is available.

Dermal irritation of the test substance Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 9174 4 -23 -9), was investigated in a study according to OECD 404 and GLP. 0.5 g of the test substance was applied to the shaved skin of three New Zealand White rabbits (semi-occlusive coverage). Total exposure was 4 h. Thereafter, the test substance was removed using warm water. Observations were made after 30-60 minutes, 24, 48, and 72 h, as well as 6, 8, and 14 days after patch removal. An adjacent area of untreated skin served as control. Mean erythema and edema scores after 24, 48, and 72 h were 1.67 and 1.11, respectively. Both were fully reversible within 14 days.

Based on the results of this test the substance is slightly irritating but does not warrant classification according to CLP.

Eye irritation

No information on eye irritation of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates was identified. However, one study from a structural analogue is available.

Eye irritation of the test substance Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salt

(CAS 91744-23-9), was investigated in a study according to OECD 405 and GLP. 0.1 cm³ of the test substance were instilled in one eye each of the three New Zealand White rabbits. Total exposure was 24 h. Thereafter, the test substance was removed using warm physiological saline. Observations were made after 1, 24, 48, and 72 h after administration. The untreated eye of each animal served as control. Marked hyperaemias of some blood vessels could be observed in all animals 1 h after application, after 24 hours no effects was noticed. Mean scores for cornea, iris, conjunctivae redness and conjunctivae chemosis after 24, 48, and 72 h were 0 for each endpoint. Based on the results of this test the substance is considered not to be an eye irritant.

Justification for classification or non-classification

Based on the available information classification for skin and eye irritation / corrosion is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.