Registration Dossier
Registration Dossier
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EC number: 426-840-1 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other:
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: summary of available data
Data source
Materials and methods
Test material
- Reference substance name:
- -
- EC Number:
- 426-840-1
- EC Name:
- -
- IUPAC Name:
- tetrasodium 7-[(2,6-difluoropyrimidin-4-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate 7-[(4,6-difluoropyrimidin-2-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- Identity: Scarlet RN 1165
Appearance : Solid powder, dark-red
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
SCARLET RN 1165 has been tested for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes as well as for skin sensitisation.
ln the test for acute oral and dermal toxicity, SCARLET RN 1165 was applied to rats at a single dose level of 2000 mg/kg body weight. Neither clinical signs nor effects on body weight or organs were noted.
ln the eye irritation test, irreversible staining of the sclera and conjunctiva but no irritation was observed.
ln a 28-day toxicity study, SCARLET RN 1165 was applied to rats at dose levels of 0, 50, 200 and 1000 mg/kg body weight daily by gavage. With the exception of red colored feces (at 200 and 1000 mg/kg), no clinical signs and no effects on body weight or food consumption were noted. Some minor changes in biochemistry and urine analysis in several animals of dose group 2 (50 mg/kg), 3 (200 mg/kg) and 4
(1000 mg/kg) were observed. These findings give rise to the assumption, that intestinal resorption will at least partly occur. Furthermore, morphological alterations in the stomach of both sexes at 200 and 1000 mg/kg indicate a slight irritant efffect on the gastric mucosa.
No other indications on the toxicokinetic behaviour of SCARLET RN 1165 could be derived from the results of the available studies.
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