Registration Dossier

Administrative data

Description of key information

Conclusions for HXL-8366 are based on read across from analogue substances of a known category. See also Report 491517_Read-across approach for REACH registration of HXL-8366 , attached under 1. General information. For one substance (EC no. 451-400-0) of the category a NOAEL of 150 mg/kg/d was observed based on marginal effects. Within the category, there is no clear relationship between this lower NOAEL and the composition of the substances, except that the percentage branched acids is very high (87%). All other esters tested containing branched fatty acids resulted in a NOAEL of 1000 mg/kg day (EC no. 430-320-1 (23%); EC no. 451-120-9 (7%); EC no. 444-000-2 (79%)). We therefore believe that the result for EC no. 451-400-0 (NOAEL = 150 mg/kg day) is an outlier and we assume the NOAEL of HXL-8366 to be 1000 mg/kg day.

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

 

 

EC #

Avg MW

Repeated dose NOAEL

[mg/kg/d]

451-070-8

525

1000

451-120-9

537

1000

451-190-0

544

Read-across

453-150-8

554

Read-across

451-200-3

585

Read-across

430-320-1

611

1000

451-110-4

613

Read-across

451-400-0

637

150

451-220-2

648

Read-across

451-180-6

652

Read-across

452-180-9

657

Read-across

453-470-8

783

Read-across

452-270-8

883

Read-across

453-480-2

1012

Read-across

444-000-2

1023

1000

453-450-9

1036

Read-across

453-490-7

1066

Read-across

453-460-3

1094

Read-across

HXL-8366 (700 -325 -4)

878

Read-across:

1000

 

Justification for classification or non-classification

Based on the information above mentioned 'discussion' the substance is not classified based on 28 -day studies available.