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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
BIBRA toxicity profile of sunset yellow FCF
Author:
The British Industrial Biological Research Agency
Year:
1995
Bibliographic source:
BIBRA Report (1995), (Order No. BIBRA196GAR), 6 pp

Materials and methods

Principles of method if other than guideline:
The eye irritation study was conducted to evaluate the irritating effects of administration of sunset yellow FCF to eye of rabbits.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
EC Number:
220-491-7
EC Name:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
Cas Number:
2783-94-0
Molecular formula:
C16H12N2O7S2.2Na
IUPAC Name:
disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
Details on test material:
- Name of test material: sunset yellow FCF
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38
- Substance type: organic
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
other: minimally irritant to the rabbit eye

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.
Executive summary:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.