Registration Dossier

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:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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