Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

271-351-7

EC Name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

68541-71-9

Molecular formula:

C32H17CrN6O11S.2Na

IUPAC Name:

disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Test material form:

other: Presscake

Details on test material:

None

Specific details on test material used for the study:

Identification: FAT 20011/E TE
Batch: 130923 (China)
Purity: 65 %
Physical state / Appearance: dark blue solid
Sponsor (bulk) description: black powder which makes a blue solution.
Expiry date: 30 Sept 2018
Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Weight at study initiation: 154 - 170 g
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): Volume (ml/kg body weight) applied: 10

Doses:

3077 mg/kg bw (2000 mg a.i./kg bw)

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: Clinical observations were made 30 minutes, I, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes, At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 3 077 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period. Blue/black colored staining of the feces was noted in the initial treated animal 1 to 5 days after dosing. Blue colored staining of the urine and/or feces was noted in the four additi

Gross pathology:

No abnormalities were noted at necropsy of the initial treated animal. Patchy pallor of the liver and dark kidneys were noted at necropsy of the four additional treated animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 3077 mg/kg bw (equivalent to 2000 mg active ingredient/kg bw).

Executive summary:

The study was performed to assess the acute oral toxicity of FAT 20011/E in the Wistar strain rats, according to OECD Guideline 420 and Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008. Following a sighting test at a dose level of 3077 mg/kg bw (equivalent to 2000 mg active ingredient/kg bw) in one female rat, an additional four fasted female animals were given a single oral dose of test item, as a solution in distilled water, at a dose level of 3077 mg/kg bw ( equivalent to 2000 mg active ingredient/kg bw). Mortality, clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy after observation period of 14 days. No deaths were observed during the course of study. No signs of systemic toxicity were noted during the observation period. Blue/black colored staining of the feces was noted in the initially treated animal 1 to 5 days after dosing. Blue colored staining of the urine and/or feces was noted in the four additional treated animals 2 hours to 7 days after dosing. All animals showed expected gains in body weight. No abnormalities were noted at necropsy of the initially treated animal. Patchy pallor of the liver and dark kidneys were noted at necropsy of the four additional treated animals.Based on these findings, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rats was estimated to be greater than 3077 mg/kg bw (equivalent to 2000 mg/kg active ingredient/kg bw) (Globally Harmonized Classification System - Unclassified).