Genipin

Endpoint summary

Description of key information

In view of the human exposure assessment and patch test, no further testing is considered to be necessary. The substance is classified as Skin Sens 1

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

Human patch test

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:

Peer reviewed research.
The research was performed after reported sensitisation by those in contact with genipin

Qualifier:

no guideline followed

Principles of method if other than guideline:

Human patch test performed following reported allergic reactions among those in contact with genipin based products to confirm the components causing allergic reactions
Genipin was demonstrated to be a skin sensitiser to humans.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

Human study

Species:

other: Human

Sex:

not specified

Route:

epicutaneous, semiocclusive

Vehicle:

DMSO

Concentration / amount:

1%

Day(s)/duration:

2 days application

Adequacy of induction:

other: Typical concentration used in cosmetic products

No.:

#1

Route:

epicutaneous, semiocclusive

Vehicle:

DMSO

Concentration / amount:

1%

Day(s)/duration:

2

Adequacy of challenge:

other: Concentration used in cosmetic products

No. of animals per dose:

Not specified

Details on study design:

Methods described as 'standard European methods for human patch testing'

Challenge controls:

The study was performed using other ingredients present in the cosmetic leading to an allergic reaction, including citric acid and potassium sorbate - these proved negative and therefore acting as controls

Positive control substance(s):

no

Positive control results:

Not tests

Reading:

other: Observations over several days from repeated application

Hours after challenge:

72

Group:

test chemical

Dose level:

1% in DMSO

Clinical observations:

No other adverse effect recorded

Remarks on result:

positive indication of skin sensitisation

Remarks:

Number of volunteers and number with reactions are not reported.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Remarks:

Reported as clear positive effects

Conclusions:

In view of the human exposure assessment and patch test, no further testing is considered to be necessary. The substance is classified as Skin Sens 1

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)