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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:
Substance name: FAT 41001/H TE
CAS No.: 72214-18-7
EC No.: 276-481-8
Appearance: Dark blue solid
Batch / Lot number: BOP 01-12 (Lot: BS-1106872)
Purity: 77.3 %
Molecular weight: 882.18 g/mol
Specific gravity: 1.416
Water solubility: 332 g/L at 20 °C
Octanol-water partition coefficient (log Pow): log Pow <3
Auto-ignition temperature [°C]: >500 °C
Inhalable Particle size: 98.5% at <100 μm
Hydrolysis Test: Estimated half life at 25 ºC is 110-126 days at pH 4, >1 year at pH 7 and pH 9.
Acute Oral Toxicity: LD50 >2000 mg/kg bw
Skin Irritation: Non-irritating to rabbit skin
Eye Irritation: Causes staining to the rabbit eye
Skin Sensitization: Sensitising to the Guinea pig skin
Repeated dose reproductive NOAEL for systemic, reproductive and screening study (422) developmental toxicity: 1000 mg/kg bw/day
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
276-481-8
EC Name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
72214-18-7
Molecular formula:
C32H26ClN7O11S3.3Na
IUPAC Name:
trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Specific details on test material used for the study:
Substance name: FAT 41001/H TE
CAS No.: 72214-18-7
EC No.: 276-481-8
Appearance: Dark blue solid
Batch / Lot number: BOP 01-12 (Lot: BS-1106872)
Purity: 77.3 %

Results and discussion

Any other information on results incl. tables

The substance is a dark blue solid with a molecular weight of 882.18 g/mol. The predicted auto-ignition temperature (non volatile) and particle size indicates the substance is unlikely to present a significant hazard via the inhalation route. The substance has a low log octanol/water partition coefficient value (Log10 Pow <3) and high water solubility (332 g/L at 20 °C). The available repeated dose reproductive screening study showed evidence of absorption, metabolism and probable route of excretion. The test item is neither a skin nor eye irritant but demonstrated to be sensitising to guinea pig skin with the added possibility of causing respiratory sensitisation. The acute oral toxicity study (LD50 >2000 mg/kg bw) and available reproductive and developmental study showed no convincing evidence of systemic toxicity and no maternal or developmental toxicity up to dose a dose level of 1000 mg/kg/day.

Applicant's summary and conclusion

Conclusions:
The available information suggests that absorption of the test substance 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 be distributed in the serum and in all likelihood excreted via the urine and faeces.
Executive summary:

The absorption, distribution, metabolism and excretion of FAT 41001/H TE have been predicted based on the following information:

FAT 41001/H TE absorption was indicated via the gastro-intestinal tract following oral gavage administration. FAT 41001/H TE no absorption was indicated via intact skin or ocular routes of exposure. However, available data confirmed the test item was a sensitizer to Guinea pig skin and also indicated to potentially cause respiratory sensitisation. FAT 41001/H TE no uptake via inhalation is anticipated on the basis that the inhalable fraction was shown from the Particle size test to be ~99% at <100 μm indicating almost all inhaled particles will be cleared in the oral/nasal region and subsequently swallowed with the mucus. FAT 41001/H TE demonstrated based on the available evidence including single oral dose and repeated oral dose reproductive screening studies that the test item and/or its predicted metabolites have limited toxic potential whether absorbed through the skin or gastro-intestinal tract.

Excretion of FAT 41001/H TE and any of its predicted metabolites is expected to be from urine and faeces.

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