Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The acute oral LD50 of FAT 40063/A in rats of both sexes observed over a period of 14 days.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate

EC Number:

274-436-7

EC Name:

Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate

Cas Number:

70210-39-8

Molecular formula:

C20H17BrN4O8S2.2Na

IUPAC Name:

disodium 5-({4-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-4-hydroxy-6-(methylamino)naphthalene-2-sulfonate

Test material form:

not specified

Details on test material:

No data

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inhouse (bred under SPF conditions in our own breeding unit)
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: Overnight
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet: (NAFAG, Gossau SG, rat food) ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approx. 50 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

FAT 40063/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was" kept stable with a magnetic stirrer.

Doses:

4640, 6000, 7750 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at 1, 24, 48 h, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weight, Gross pathology

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 750 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was found at any dose level

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. However, all animals had recovered within 8 days

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 40063/A in rats is greater than 7750 mg/kg bw

Executive summary:

FAT 40063/A was tested on 30 Tif. RAI rats (15 males and 15 females), at the dose level of 4640, 6000 and 7750 mg/kg bw. FAT 40063/A was weighed into an Erlenmeyer flask on a Mettler balance and suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment, the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. The rats were starved during one night before starting the treatment. Within 2 hours after treatment, the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 8 days. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Based on the study results, the acute oral median lethal dose (LD₅₀) of FAT 40063/A in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg based on test material.