Registration Dossier

Administrative data

Description of key information

Skin irritation: A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant study with alkenes, C11-12, hydroformylation products, distillation residues in NZW rabbits was conducted according to EPA OPPTS 870.2500 (Acute Dermal Irritation). Following a 4 hour semi-occlusive exposure the test item was found to be not-irritating to skin (according to EU criteria).
Eye Irritation: A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant eye irritation study was conducted with alkenes, C11-12, hydroformylation products, distillation residues. The study was conducted in NZW rabbits according to EPA OPPTS 870.2400 (Acute Eye Irritation). The test item in this instance was reported to be not-irritating to eyes (according to EU criteria).

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

Alchisor CAL 145 comprises alkenes C13-14 hydroformylation products with read-across from the chemically-similar Alchisor CAL 123 as defined in the `Read-Across Justification Document'. Where toxicological data exist for Alchisor CAL 123, these are representative of the Alchisor CAL 145 substance.

Skin Irritation

A primary dermal irritation study was conducted in three albino rabbits using test substance Alkenes, C11 -12, hydroformylation products, distillation residues (CAS No: 90622 -27 -8). There was one intact test site per animal. Each test site was treated with 0.5 mL of the undiluted test substance and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings. Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study. One animal was found dead on Day 1 of the study; the death was not considered related to the administration of the test substance. A replacement animal was dosed. The test item was found to be non-irritating to skin (according to EU criteria).

Eye Irritation

An acute eye irritation study was conducted on three albino rabbits using test substance alkenes, C11 -12, hydroformylation products, distillation residues (CAS No: 90622 -27 -8). 0.1 mL of the test substance was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation. There were no positive effects exhibited in any eyes at 48 hours after treatment. Non-positive irritation was clear by 72 hours. According to EU criteria the test item in this instance was reported to be non-irritating to eyes.

Justification for classification or non-classification

These findings do not warrant the classification of alkenes, C11 -12, hydroformylation products, distillation residues (CAS No: 90622 -27 -8) as skin or ocular irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.