Registration Dossier

Administrative data

Description of key information

Oral: A reliable (Klimisch 1) GLP compliant OECD 425 acute oral toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with alkenes, C11-12, hydroformylation products, distillation. residues. The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats (Kuhn 2010a).
Dermal: A reliable (Klimisch 1) GLP compliant OECD 402 semi-occlusive acute dermal toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with alkenes, C11-12, hydroformylation products, distillation. residues. The acute dermal LD50 was greater than 2020 mg/kg bw in male and female rats (Kuhn 2010b).

Key value for chemical safety assessment

Additional information

Oral

A reliable (Klimisch 1) GLP compliant OECD 425 acute oral toxicity (Up-and-Down Procedure) study was conducted in Sprague-Dawley rats (5/sex/dose). The test item in this study was alkenes, C11-12, hydroformylation products, distillation. residues (CAS No. 90622 -27 -8, commercial name: Alchisor CAL). No mortality occurred during the study. There were no clinical signs of toxicity during the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

 

Dermal

The test substance, alkenes, C11 -12, hydroformylation products, distn. Residues (CAS No. 90622 -27 -8), was evaluated for its dermal toxicity potential and relative skin irritancy when a single undiluted dose of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There were no clinical signs of toxicity of signs of dermal irritation at any time throughout the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.

 

Inhalation

Physico-chemical properties of alkenes, C11 -12, hydroformylation products, distillation. residues can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance alkenes, C11 -12, hydroformylation products, distillation. residues is of low volatility with a measured vapour pressure <0.5 pa. Consequently acute inhalation toxicity testing for this test item is not required.

Justification for classification or non-classification

The test substance, alkenes, C11-12, hydroformylation products, distillation. residues is of low acute toxicity via ingestion (oral LD50 >2000mg/kg bw) or via dermal exposure (dermal LD50 >2020mg/kg bw). These findings do not warrant classification of alkenes, C11-12, hydroformylation products, distillation. residues under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).