Reaction mass of sodium aqua[5-{[2-hydroxy-4-(hydroxy-kO)-5-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl}phenyl]diazenyl}naphthalene-1-sulfonato(3-)]ferrate(1-) and sodium diaqua(chloro)[5-{[2-hydroxy-4-(hydroxy-kO)-5-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}phenyl]diazenyl}naphthalene-1-sulfonato(3-)]ferrate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Analogue Substance_01

IUPAC Name:

Analogue Substance_01

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, D-7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 181 g (males), 174 g (females)
- Fasting period before study: at least 16h, with water ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DLK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 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)

Details on oral exposure:

- Concentration of test material in vehicle: 11%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: aquous formulation corrresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

2200 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 day
- Frequency of observations and weighing: recording of signs and symptomps several times on the day of administration, at least once each workday; individually body weights shortly before application (day 0), and on days 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: In the male and female animals was black discolored feces. Males additionally exhibited piloerection and black smeared fur in the anogenital area

Gross pathology:

No pathological findings

Other findings:

Symptoms after administration of 2200 mg/kg bw of test material in vehicle by gavage:

Males:
day1-day2: piloerection (2/3 animals)
hour4-day2: discoloured feces (black) (3/3 animals)
hour4-day3: black smeared fur in the anogenital area (2/3 animals)

Females:
hour1-day1: discoloured feces (black) (3/3 animals)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The analogue substance was tested for acute oral toxicity following OECD 401. The tested sample showed LD50 (rat, oral) > 2200 mg/kg bw, without mortality or gross pathological changes.