Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

In the table below the aquatic toxicity data are summarised:

 Species  Guideline(s)  Result in mg/l

Remarks

Pseudokirchneriella subcapitata

 

OECDTG 201 (2011)

OECD Series on Testing and Assessment, No. 23, 2000

72h-ErL50 : 40.4

72h-ErL10 : 13.2

72h-NOELR : 3.2

Results based on nominal loading

  

Key study, Rel 1,

WAF test with GC-FID confirmation 

 Daphnia magna

  

OECDTG 202 (2004)

OECD Series on Testing and Assessment, No. 23, 2000

 48h-EL50: 6.39

 Result based on nominal loading

   

Key study, Rel 1,

WAF test with GC-FID confirmation 

Additional information

No study information is available regarding the toxicity to aquatic organisms of the substance Ginger oil CO2-Total Extract. However, there is sufficient weight of evidence information available from two independent sources to provide appropriate evidence to fulfil the information requirements. Therefore, in line with section 1.2 of Annex XI in regulation (EC) No 1907/2006, a weight of evidence (WoE) approach was used. In this WoE approach the results from OECD TG 201, GLP studies, performed on two qualities of ginger oil extracts (Ginger CO2-SE extract and Ginger oil Hot Flavor CO2-TO extract) were used in order to fulfil the toxicity to aquatic organisms endpoints for Ginger oil CO2-Total Extract. These two qualities of ginger oil constitute to the volatile and the non-volatile fraction of the target UVCB (Ginger oil CO2-Total Extract). The two fractions combined cover the constituents present in Ginger oil CO2-Total Extract, albeit in higher concentration ranges in both fractions. By assessing the study results of both fractions in a WoE approach, there is adequate and reliable information available to assess if Ginger oil CO2-Total Extract has or has not a particular dangerous property.

For both extracts, toxicity to aquatic organisms was found in the same order of magnitude (difference less than a factor of 2). For this summary the selective extract values were selected as worst-case.