Genipin

Endpoint summary

Description of key information

Considered mild irritant to eye, although borderline Eye Irrit 2. 

No adverse effects ot the skin following repeated administration to rabbits. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Remarks:

Non-EU study performed for research into use in skin repair matrices Genipin is used as a crosslinking aid in skin repair matrix for plastic surgery

Type of information:

experimental study

Adequacy of study:

key study

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:

Study performed as part of academic research using non-regulatory systems
Considered suitable for classification.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Claimed to follow key parts of guidelines, but study was done with repeated 6 hour contact under occlusive dressings.

Principles of method if other than guideline:

Claimed to be in line with international guidelines in terms of animal handling, but study involved repeated application so the animals over 14 days

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

Applied without vehicle
Amount applied not specified

Duration of treatment / exposure:

14 days

Observation period:

14 days

Number of animals:

Not specified. At least 6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

1

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Remarks:

Note that the animals were subject to daily treatment for 14 days with no indication of adverse effects

Irritant / corrosive response data:

No adverse effects

Other effects:

No adverse effects

Interpretation of results:

GHS criteria not met

Conclusions:

The non-standard guideline study with repeated application to the anials demonstrated no adverse effects.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Remarks:

Performed outside the EU as part of academic medical research Published data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Performed as biological screening prior to work as medicinal product outside the EU
Published data in peer reviewed journal
Individual animal data not included in the publication

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Performed with Draize scoring to meet GHS criteria

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

5 males, 5 females

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Single application

Observation period (in vivo):

Up to 15 days post treatment

Number of animals or in vitro replicates:

5 males, 5 females

Irritation parameter:

conjunctivae score

Remarks:

Includes chemosis in results

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within: 3 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 3 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.5

Max. score:

1

Reversibility:

fully reversible within: 3 days

Irritant / corrosive response data:

Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified

Other effects:

Not reported

Conclusions:

Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified
It is noted that this in-vivo assay to verify eye irritation before conducting an in-vitro assessment on corneal repair materials was no in accordance with European ethical procedures.
However, the published data provides evidence of low irritation to eyes in terms of corneal damage, but resulted in chemosis.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)