Genipin

Skin sensitisation

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Genipin in Temporary Jagua Tattoos – Black Dye Causing Severe Allergic Dermatitis

Author:

Bircher, Andreas J. MD

Year:

2019

Bibliographic source:

Dermatitis: 11/12 2019 - Volume 30 - Issue 6

Materials and methods

Test guideline

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

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

In vivo test system

Test animals

Species:

other: Human

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, semiocclusive

Vehicle:

DMSO

Concentration / amount:

1%

Day(s)/duration:

2 days application

Adequacy of induction:

other: Typical concentration used in cosmetic products

Challenge

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

Results and discussion

Positive control results:

Not tests

In vivo (non-LLNA)

Results

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.

Applicant's summary and conclusion

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