Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Expert assessment

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Assessment of toxicokinetic behaviour based on physicochemical properties and toxicology data

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

271-351-7

EC Name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

68541-71-9

Molecular formula:

C32H17CrN6O11S.2Na

IUPAC Name:

disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Specific details on test material used for the study:

Substance name: FAT 20011/E TE
Batch/Lot number: 1309023 (China)
Appearance: Dark blue solid
Purity: 61.2%
pH: 7.9 [Conc. (% w/w): 1%]
Molecular weight†: 791.55 g/mol

Results and discussion

Any other information on results incl. tables

The substance composed is a dark blue solid with a molecular weight of 791.55 g/mol. The predicted self-ignition temperature (low volatility), melting point and particle size indicate the substance is unlikely to present a significant hazard via the inhalation route which is further supported by the fact that the test product is intended for industrial and professional use only in the form of dedusted granules or liquid formulations.

The substance has a low log octanol/water partition coefficient value (Log Pow 0.291) and high water solubility (200 g/L).

The available repeated dose reproductive screening study showed evidence of absorption, distribution metabolism and probable routes of excretion. Read across data from a closely related test item indicated FAT 20011/E TE to be potentially irritant to the skin and eyes, to be a skin sensitizer and potentially mutagenic (in bacteria). The acute oral toxicity results for FAT 20011/E TE indicated the LD50 to be >3000 mg/kg body weight and an oral gavage combined toxicity reproductive and developmental toxicity study with FAT 20011/E TE showed no convincing evidence of systemic toxicity nor any adverse effects on maternal or developmental toxicity up to a dose level of 1000 mg/kg/day.

Applicant's summary and conclusion

Conclusions:

The available information suggests that absorption of FAT 20011/E TE will primarily take place in the gastrointestinal tract following oral ingestion. Some absorption may also take place via damaged skin. Once absorbed, the substance would primarily be distributed in the serum with excretion via the urine and faeces.

Executive summary:

The absorption, distribution, metabolism and excretion of FAT 20011/E TE has been predicted based on the following information:

FAT 20011/E TE; the available information indicates absorption in all probability would be via the gastrointestinal tract subsequently entering the circulatory system in the blood. This assertion was supported by results from a repeated dose reproductive screening study performed for FAT 20011/E TE.

Supplementary information indicated FAT 20011/E TE to be potentially slightly irritant to the skin and eyes and to be a skin sensitizer. However, the evidence from the single dose oral toxicity and repeated oral dose reproductive screening studies performed for FAT 20011/E TE confirmed the test item has minimal toxic potential.

FAT 20011/E TE on the basis of supporting information is considered not to present a risk of uptake via the inhalation route.

FAT 20011/E TE the evidence from the repeated dose reproductive screening study showed that FAT 20011/E TE and/or its predicted metabolites have the potential for systemic distribution throughout the body although the repeated dose study indicated little evidence of systemic toxicity.

The studies conducted for FAT 20011/E TE provided evidence to indicate absorption will primarily take place in the gastrointestinal tract following oral ingestion with some absorption potentially also taking place via the skin; once absorbed, the test substance would primarily be distributed in the serum. There was no evidence to indicate test item or metabolite influenced hepatic metabolism. Excretion of the test substance and/or its metabolites would predominantly be via the urine and faeces.