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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer-reviewed jornal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The Absorption, Metabolism and Excretion of the Sulphonated Azo Dye, Acid Yellow, by Rats
Author:
Ronald R. Scheline and Britt Longberg
Year:
1965
Bibliographic source:
Acta pharmacol. el toxicol. 1965, 23, 1-14
Reference Type:
secondary source
Title:
Information P·roflles on Potential Occupational Hazards: Aminoazobenzenes
Author:
National Institute for Occupational Safety and Health
Year:
1981
Bibliographic source:
U.S. DEPARTMENT OF COMMERCE NATIONAL TECHNICAL INFORMATION SERVICE, November 1981, 1-116

Materials and methods

Objective of study:
other: Absorption, Metabolism and Excretion
Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Absorption, Metabolism and Excretion of Acid Yellow in rats
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate
EC Number:
220-293-0
EC Name:
Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate
Cas Number:
2706-28-7
Molecular formula:
C12H11N3O6S2.2Na
IUPAC Name:
disodium 2-amino-5-[(4-sulfonatophenyl)diazenyl]benzenesulfonate
Constituent 2
Reference substance name:
Acid Yellow
IUPAC Name:
Acid Yellow
Details on test material:
- Name of test material (as cited in study report): Acid Yellow
- Molecular formula (if other than submission substance): C12H11N3O6S2.2Na
- Molecular weight (if other than submission substance): 401.3301 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 34 %
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 250 to 350 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):water , ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
VEHICLE
- Concentration in vehicle: 100 mg
- Amount of vehicle (if gavage): 1 ml
Duration and frequency of treatment / exposure:
3 days
Doses / concentrations
Remarks:
Doses / Concentrations:
100 mg -oral
2 mg- intraperitoneal
No. of animals per sex per dose / concentration:
No data
Control animals:
not specified
Positive control reference chemical:
No data
Details on study design:
No data
Details on dosing and sampling:
No data
Statistics:
No data

Results and discussion

Preliminary studies:
No data

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Total gastrointestinal absorption was observed in rat by oral route
Details on distribution in tissues:
No data
Details on excretion:
Only 2.6, 0.0, and 0 .1.2S. of the unchanged compound appeared in the urine, feces, and bile, respeot1vely and 87% intraperitoneal amount found in the urine. prolonged excretion in bile. Total 1.1 % was excreted in urine.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate was metabolite in the form of N-acetylsulphanilic acid and 5-acetylamino- 2-aminobenzene sulphonic acid conjugate respectively.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Acid Yellow was considered to be have Low bio-accumulation potential in rats based on study results.
Executive summary:

Upon oral administration, Acid Yellow were totally absorbed by gastrointestinal trak, metabolite in the form of N-acetylsulphanilic acid and 5-acetylamino- 2-aminobenzene sulphonic acid conjugaterespectively. only 2.6, 0.0, and 0 .1.2S. of the unchanged compound appeared in the urine, feces, and bile, respeot1vely and 87% intraperitoneal amount found in the urine. prolonged excretion in bile. Total 1.1 % was excreted in urine at 24 hours and not identified after 42 hours. Theefore Acid Yellow was considered to be have Low bio-accumulation potential in rats based on study results.