Registration Dossier

Administrative data

Description of key information

Vinyl Neodeconoate is practically not toxic by the oral. dermal and inhalation routes of exposure in laboratory animals.  The acute rat oral LD50 was > 8.8 - 23 grams/kg of body weight.  The acute rat 4 hr inhalation LC50 was > 2.6 mg/L (> 2600 mg/m3).  The acute dermal LD50 ranged from > 3.5 grams/kg to > 15 grams/kg of body weight.   

Key value for chemical safety assessment

Additional information

Vinyl Neodeconoate is not acutely toxic to laboratory animals by the oral, dermal and inhalation routes of exposure. Based on lack of hazard and exposure, and ECHA RIP 3.2 Guidance (Chapter R.8, Section R.8.1.2.5, "Duration of exposure", Acute DNELs are derived for the "Inhalation route only". ) acute oral and dermal DNELs are not required. The Worker Acute Inhalation DNEL is based on the rat 4 hr acute inhalation study with an LC50 value of > 2.6 gm/m3. Following ECHA RIP 3.2 Guidance (Chapter R.8, page 27) this value is converted to a human equivalent value of 108 ppm. The total Interspecies/Intraspecies Adjustment Factor (2.5 x 5) of 12.5 is applied = 8.6 ppm. Since the Acute DNEL value is protective for short-term exposure only, no adjustment for prolonged - repeated -dose effects is required. However, since the exposure of rats was for 4 hr and the Acute Worker DNEL is intended for fifteen minute exposures only (ECHA RIP Chapter R.8, Section R.8.1.2.5, page 16) this value is adjusted by 4 hr/15min = 16 -fold or 8.6 ppm x 16 = approximately 140 ppm/15 minutes. An Acute Consumer/General Public Inhalation DNEL is not required because these populations will not be exposed to high levels of vinyl neodecanoate encouterd by maintenance workers.

Justification for classification or non-classification

No classification and labeling required for acute toxicity hazard based on available data and EU regulatory established limits (EU Directive 67/548/EEC and the CLP, Directive EC 1272/2008 16 December 2008).