Genipin

Long-term toxicity to fish

Administrative data

Endpoint:

long-term toxicity to fish, other

Remarks:

70 day feeding study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

70 days

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Peer reviewed research on the use of genipin in fish diet to enhance growth

Data source

Reference

Reference Type:

publication

Title:

Effects of Dietary Geniposide on Growth, Flesh Quality, and Lipid Metabolism of Grass Carp, Ctenopharyngodon idella

Author:

Sun et al

Year:

2017

Bibliographic source:

Journal of the World Aquaculture Society, Vol 48 No 6

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Fish were fed with different levels of unrefined genipin mixed into diet to evaluate safety and to confirm if any improvement in growth rates

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Genipin

EC Number:

636-196-5

Cas Number:

6902-77-8

Molecular formula:

C11H14O5

IUPAC Name:

Genipin

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Material was the unrefined form of genipin, referred to as geniposide
When extracted, genipin is about 60% w/w 'actives'

Sampling and analysis

Analytical monitoring:

yes

Remarks:

Diet was analysed

Details on sampling:

Each batch of diet analysed

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Ctenopharyngodon idella

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

70 d

Remarks on exposure duration:

Period chosen to ensure growth and muscle development could be assessed

Test conditions

Hardness:

Not specified

Test temperature:

Maintained 25 - 30 C

pH:

MAintained pH 7 - 8

Dissolved oxygen:

Maintained at > 5 mg/l

Nominal and measured concentrations:

Feeding 100, 200, 400, 600 and 800 mg/kg bodyweight
Feed concentrations were based on measured body weights.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

70 d

Dose descriptor:

NOEC

Effect conc.:

> 480 other: mg/kg

Nominal / measured:

meas. (initial)

Conc. based on:

act. ingr.

Basis for effect:

adult mortality

Effect concentrations 2

Duration:

70 d

Dose descriptor:

NOEC

Effect conc.:

> 800 other: mg/kg bodyweight

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

adult mortality

Details on results:

At the higher levels of administration, fish fed with genipin had a reduced body-fat content and increased muscle groth

Applicant's summary and conclusion

Validity criteria fulfilled:

not applicable

Conclusions:

Although a feeding study, it is noted that high dose levels by ingestion failed to cause toxici effects in adult fish