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Registration Dossier
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EC number: 226-736-4 | CAS number: 5460-09-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary information taken from OECD SIDS document. Original report given as of high quality, but not available for review.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Initial Targeting Assessment Report For SIAM 31 Paris, France, 19-22 October 2010
- Author:
- OECD
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium hydrogen 4-amino-5-hydroxynaphthalene-2,7-disulphonate
- EC Number:
- 226-736-4
- EC Name:
- Sodium hydrogen 4-amino-5-hydroxynaphthalene-2,7-disulphonate
- Cas Number:
- 5460-09-3
- Molecular formula:
- C10H9NO7S2.Na
- IUPAC Name:
- sodium hydrogen 4-amino-5-hydroxynaphthalene-2,7-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 w/v% methylcellulose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, 300, 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The repeated doseoraltoxicity study in rats was conducted underJapaneseGuidelineunder Chemical Substances Control Law (28-Day Repeated Dose Toxicity Test in Mammalian Species)in compliance with GLP (MHW,Japan,1994).Monosodium 4-amino-5-hydroxynaphthalene-2,7-disulphonate (purity; 87.4%)was administered orally by gavage to male and femaleCrj:CD(SD)rats (6or 12animals/sex/group) for 28 days at doses of 0 (vehicle control: 1 w/v% methylcellulose),30, 100, 300, 1000mg/kg bw/day.The doses have been recalculated to take account of the impurities. Sixmale and6female rats from0and1000mg/kg bw/day groups were allocated as the recovery groups.
No death was observed in both sexes. There were no adverse effects on any observationsincludingbody and organ weights, blood and urine analyses, and microscopic examination of the liver and kidney.Based on the results, the NOAEL of repeated dose oral toxicity was 1000mg/kg bw/dayin both sexes.
Applicant's summary and conclusion
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