Sodium tris(1,2-naphthoquinone 1-oximato-O,O')ferrate(1-)

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from Reports of the Scientific Committee on Cosmetology (seventh series)

Data source

Reference

Reference Type:

secondary source

Title:

Reports of the Scientific Committee on Cosmetology (seventh series)

Author:

Commission of the European Communities

Year:

1988

Bibliographic source:

Directorate-General Environment, Consumer Protection and Nuclear Safety- Commission of the European Communities- Brussels Luxembourg, 1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The substance Ferric Complex of 1-Nitroso-6-sodium-sulfo-2-hydroxynaphthalene was tested for its potential toxic effects after repeated exposure via oral route of administration.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)

EC Number:

243-010-2

EC Name:

Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)

Cas Number:

19381-50-1

Molecular formula:

C30H15FeN3O15S3.3Na

IUPAC Name:

trisodium; 6-hydroxy-5-nitrosonaphthalene-2-sulfonate; iron

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ferric Complex of 1-Nitroso-6-sodium-sulfo-2-hydroxynaphthalene
- Molecular formula (if other than submission substance): C30H15FeN3015S3•3Na
- Molecular weight (if other than submission substance): 987
- Substance type: organic
- Physical state: solid

Test animals

Species:

rat

Strain:

not specified

Details on species / strain selection:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

not specified

Frequency of treatment:

5 days/week

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 000 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

2 000 mg/kg bw/day (nominal)

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Positive control:

not specified

Examinations

Observations and examinations performed and frequency:

not specified

Sacrifice and pathology:

not specified

Other examinations:

not specified

Statistics:

not specified

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

no mortality observed

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Effect levels

Dose descriptor:

NOAEL

Effect level:

2 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: no deleterious (toxic) effects observed

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The No Observed Adverse Effect Level (NOAEL) for trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) in rats is considered to be 2000 mg/kg bw/day after repeated exposure via oral route.

Executive summary:

The substance Ferric Complex of trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3 -) (CAS No. 19381-50-1) was tested for its potential toxic effects after repeated exposure via oral route of administration. The test animal considered for the study was rats. The test substance was exposed via gavage route at concentration of 1000 or 2000 mg/kg bw/day at frequency of 5 days/week for 13 weeks. Treatment of rats with the test chemical did not induce any deleterious effects. Hence, the No Observed Adverse Effect Level (NOAEL) fortrisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) in rats is considered to be 2000 mg/kg bw/day after repeated exposure via oral route.