Registration Dossier
Registration Dossier
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EC number: 904-908-6 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
Although REACH does not specifically require generation of toxicokinetic information, it does require that all relevant available information is used to assess the toxicokinetic behaviour of a substance, and that human health hazard assessment considers the toxicokinetic profile of the substance.
Isoamyl Salicylate is a small organic molecule and the physico-chemical properties suggest it is likely to be absorbed via dermal, inhalation and gastric routes following exposure.
Acute and subchronic toxicity data indicate that Isoamyl Salicylate is absorbed following administration by gavage and metabolised by the liver. No specific studies on the absorption, distribution, metabolism and elimination (ADME) of are available. However the very low toxicity of Isoamyl Salicylate suggests that it may be considered inappropriate at this time to conduct further animal work to support ADME.
Isoamyl Salicylate: (Target)
Molecular weight: 208.26 Da
Water solubility: 5.5 mg/L in ultrapure water
Partition coefficient: log Kow = 4.95m
The main hydrolysis product of all the salicylate substances is salicylic acid (Belsito et al, 2007). The alcohols and acids that are formed as metabolites of salicylates are without significant toxicity. The hydrolysed side chains are metabolized by common and well characterized metabolic pathways. These primary alcohols (butanol, pentanol, hexanol, octanol, and propanol) and their corresponding aldehydes and acids have also been evaluated by JECFA (2001) who found them to have no safety concerns based on their current levels as food flavours.
The toxicity data on salicylates demonstrate that, under conditions of sufficient exposure, there is a pattern of toxicity in vivo that is similar to that caused by salicylic acid at comparable doses (Belsito et al).
Further, the reproductive and developmental toxicity of alcohol products that are formed upon hydrolysis of salicylates was evaluated by the Maximum workplace concentration (Maximale Arbeitsplatzkonzentration, a. k. a. MAK) commission and concluded that 2- ethyl hexanol, methanol, ethanol, butyl alcohol, Octanol and isobutyl alcohol show no reproductive/developmental potential when used at levels ranging from 200–8000 ml/m3 for inhalation studies and 130–300 mg/kg for dietary studies.
Value used for CSA:
Bioaccumulation potential: no bioaccumulation potential
Absorption rate - oral (%): 50
Absorption rate - dermal (%): 50
Absorption rate - inhalation (%): 100
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