Registration Dossier

Administrative data

Description of key information

Conclusions for repeated dose toxicity (oral and dermal route) of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) (Hatcol 1106) are based on read-across from analogue substances of an existing category (pentaerythritol and dipentaerythritol esters), of which the members were notified under Directive 67/548/EEC (NONS) in 2003/2004. In view of structural similarities and similar physicochemical properties of the substance of interest with respect to the other substances in the category it was concluded that the NOAEL of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) (Hatcol 1106) is ≥1000 mg/kg bw/d.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Additional information

Data for repeated dose toxicity are available for 4 members of the category.

 

For all substances tested, a NOAEL of 1000 mg/kg/d was observed. Treatment related adverse effects were not reported in any of the tests performed. In view of the structural similarity, physicochemical properties and data available the NOAEL of the substance of interest is 1000 mg/kg bw/d.

 

EC #

451-070-8

451-120-9

230-743-8

453-470-8

452-270-8

453-480-2

444-000-2

270-470-1

CAS #

70693-33-3

156559-00-1

7299-99-2

70851-05-7

-

70851-04-6

70693-38-8

68441-66-7

Avg MW

525

537

640

783

883

1012

1023

833

Repeated dose

NOAEL [mg/kg/d]

1000

1000

1000

read-across

read-across

read-across

1000

read-across: 1000

Avg MW = Average molecular weight

Justification for classification or non-classification

Based on the above mentioned result, classification according to the CLP Regulation (EC) 1272/2008 and the Dangerous Substance Directive 67/548/EC is not necessary.