2-(3,6-dihydroxy-2,4,5,7-tetraiodoxanthen-9-yl)benzoic acid, aluminium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

publication

Title:

OPINION ON CI 45430 (Erythrosine) _ Skin sensitization

Author:

Scientific Committee on Consumer Safety SCCS OPINION

Year:

2010

Bibliographic source:

Scientific Committee on Consumer Safety SCCS; 22 June 2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Test was performed by using OECD Guideline 406 (Skin Sensitisation).

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

EC Number:

240-474-8

EC Name:

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

Cas Number:

16423-68-0

Molecular formula:

C20H8I4O5.2Na

IUPAC Name:

disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate

Constituent 2

Reference substance name:

Erythrosine

IUPAC Name:

Erythrosine

Details on test material:

Details on test material
- Name of test material (as cited in study report): Erythrosine (16423-68-0)
- Molecular formula (if other than submission substance): C20-H6-I4-O5.2Na
C20-H8-I4-O5.2Na
- Molecular weight (if other than submission substance): 879.8424 g/mol
- Substance type: Organic
- Physical state: Solid(powder)
- Purity: No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: Sodium chloride and Freund’s adjuvans

Induction 2

Concentration / amount:

0.1%

Challenge

Challenge 1

Route:

other: 1st challenge : Intradermal 2nd challenge : Epidermal, occlusive

Vehicle:

other: Sodium chloride and Freund’s adjuvans

Challenge 2

Concentration / amount:

0.1%

No. of animals per dose:

19 animals

Details on study design:

Details on study design
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: Upto 10 intradermal injections
- Test groups: 19 animals
- Control group: No data available
- Site: intradermal injection
- Frequency of applications: 10 intradermal injections
- Duration: No data available
- Concentrations: 0.1%

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1st challenge after
14 days (intradermally), 2nd challenge after additional 10 days (epidermally, occlusive)
- Exposure period: No data available
- Test groups: 19 animals
- Control group: No data available
- Site: No data available
- Concentrations: 0.1%
- Evaluation (hr after challenge): No data available

Positive control substance(s):

yes

Remarks:

Tartrazin

Results and discussion

Positive control results:

Tartrazin
Sodium chloride was used as negative control

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

11

Total no. in group:

19

Clinical observations:

Epidermal challenge did not cause an effect on skin

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 0.1%. No with. + reactions: 11.0. Total no. in groups: 19.0. Clinical observations: Epidermal challenge did not cause an effect on skin.

Any other information on results incl. tables

Positive reactions could be observed in 11 of 19 erythrosine-treated animals. After the epidermal challenge, none of the 19 animals exhibited signs of positive reactions. Therefore, a further intradermal challenge was performed later on after which 15 of 19 animals reacted positive

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Erythrosine (16423-68-0) does not exhibit the skin sensitization potential as has been observed from the study on guinea pigs for a period of 3 weeks

Executive summary:

Skin sensitization test was performed on Guinea pig with 0.1% solution of erythrosine for 3 weeks.

Animals received 10 intradermal injections of a 0.1% solution of the colour. The last six injections were given using Freund’s adjuvans. After 14 days, a further intradermal injection was given as challenge. A second epidermal, occlusive challenge was given after additional 10 days. After a further intradermal challenge, positive reactions could be observed in 11 of 19 erythrosine-treated animals. After the epidermal challenge, none of the 19 animals exhibited signs of positive reactions. Therefore, a further intradermal challenge was performed later on after which 15 of 19 animals reacted positive.

Epidermal challenge did not cause any effect on skin; hence, erythrosine is not regarded as a skin sensitizer.

According to the CLP regulation, the substance does not classify as a skin sensitizer.