Reaction products of 2-hydroxy-6-nitro-4-sulphonaphthalene-1-diazonium coupled with resorcinol, subsequently coupled with diazotised 5-amino-2-anilinobenzenesulphonic acid, iron(III) complexes, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Oral toxicity

Year:

1993

Bibliographic source:

Echa website

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

EC Number:

400-720-9

EC Name:

Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

Molecular formula:

C22H11FeN6NaO10S.H2O

IUPAC Name:

Monosodium aqua-[(5-((E)-(5-((Z)-(3,5-dinitro-2-oxidophenyl)diazenyl)-2-hydroxy-4-oxidophenyl)diazenyl)naphthalene-2-sulfonate)ferrate(-)]

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Dr. K. Thomae GmbH, 7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 220 g (males), 191 g (females)
- Fasting period before study: 16 hours before administration, but water was available ad libitum
- Housing: five per cage in stainless steel wire mesh cages, type DK III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiät,Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

5000 mg/Kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration, then at least once each workday. Check for moribund and dead animals twice each workday and once daily at weekends and on holidays. Body weights were recorded shortly before administration and on day 3,7 and 13
- Necropsy of survivors performed: yes
- Other examination performed: clinical signs, body weights

Statistics:

LD50 was calculated according to Probit or other suitable methods.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

other: Black feces on days 1-3

Gross pathology:

No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

other: Pratically non toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was tested for acute toxicity oral following OECD 401. This limit test study shows that the LD50 (rat/oral) is > 5000 mg/kg bw.No mortality or gross pathological changes were observed.