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Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other:
Adequacy of study:
weight of evidence
Study period:
2021
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)
EC Number:
227-030-9
EC Name:
4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)
Cas Number:
5610-94-6
Molecular formula:
C₄₃H₂₂N₆O₁₃S₃
IUPAC Name:
4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)
Test material form:
solid

Results and discussion

Applicant's summary and conclusion

Executive summary:

Resorption

In general, oral absorption is favored for molecular weights below 500 g/mol and octanol water distribution coefficients (logP) below 5. In addition, the number of hydrogen bond donors (the total number of nitrogen–hydrogen and oxygen–hydrogen bonds) should not exceed 5 and the number of hydrogen bond acceptors (all nitrogen or oxygen atoms) should be below 10.

Diazo PW 980 has a molecular weight of 980 g/mol and a logP value of < 3.8 was calculated. The number of hydrogen bond donors or acceptors is zero or 13, respectively. These data suggest a low bioavailability after oral exposure.

Diazo PW 980 is a yellow solid substance that was investigated in toxicological assays for acute toxicity and for repeated dose toxicity and reproductive screening toxicity in a combination study.

In the acute oral toxicity study, the administration of 5000 mg Diazo PW 980 / kg bw resulted in no mortality. The gross pathological examination revealed no organ alterations. Colored yellow faeces have been observed during the clinical observations.

In the OECD 422 study, administration of Diazo PW 980 by once daily oral gavage was well tolerated in rats at levels of 1000 mg/kg/day without in-life observations of toxicity or histopathological findings in the F0 or F1 generation. Clinical observation confirmed the abnormal colored faeces (yellow) in the males and females of the high dose group. However, this finding was considered not to be adverse.

The absence of any toxicologic relevant finding in both assays and the clinical observation of abnormal yellow faeces suggest that no resorption occurs after oral administration.

 

Distribution and Metabolisms

Without resorption, metabolism in the liver as main metabolic centrum is unlikely. This is supported by absence of any toxicological relevant finding during the single dose or the repeated dose oral toxicology studies performed.

Excretion

The absence of toxicological findings and the clinical observation of colored yellow faeces suggests, that Diazo PW 980 is not resorbed and directly excreted via the gut.