6-(2-chloro-6-cyano-4-nitrophenylazo)-4-methoxy-3-[N-(methoxycarbonylmethyl)-N-(1-methoxycarbonylethyl)amino]acetanilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 December 1998 to 14 January 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP methodology followed and OCED guideline 423 used to performed the experiment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-500-8

EC Name:

-

Cas Number:

204277-61-2

Molecular formula:

Hill formula: C23 H23 Cl N6 O8 CAS formula: C23 H23 Cl N6 O8

IUPAC Name:

methyl 2-({4-[2-(2-chloro-6-cyano-4-nitrophenyl)diazen-1-yl]-5-acetamido-2-methoxyphenyl}(2-methoxy-2-oxoethyl)amino)propanoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rat

Strain:

other: Rat HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 8 weeks (male) and 10 weeks ( female)
- Body weight rage when treated: 200.7-214.8 g (male) and 176.6-184.2 (female)
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Acclimatization: 7 days week under laboratory conditions, after health examination.
- Diet: ad libitum
- Water : ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%):40-70%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hour light and 12 hour dark, music was palyed for approximately 8 hours during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PEG 300)

Details on oral exposure:

Test article preparation:
The test article was placed into a glass beaker on a tared Mettler PG 503-S balance and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a glass rod and magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before each dosing.

Doses:

Dose / kg body weight: 2000 mg
Application volume / kg body weight: 10 ml

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Four times during test day 1 and once daily during days 2-15
Body weight: On test day 1 (pre-administartion), 8 and 15.
Clinical signs: Each animal was examined for changing in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were reccorded.
- Necropsy of survivors performed: yes Necropsy were performed by experineced prosectors. At the end of teh observation period all animals were sacrified by intrperitoneal injection of NARCOREN at a dose of at least 2.0ml/kg body weight (equivalent to at least mg sodium pentobarbitone/kg body weght)
- Other examinations performed: clinical signs, body weight.

Statistics:

No statistical analysis was used as no deaths occured.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50 is greater than 2000 mg/kg.

Executive summary:

The purpose of this study was to assess the acute oral toxicity of FAT 41024/B when administred by single oral gavage to rats, followed by an observation period of 14 days.

The experiment was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Two groups , each using three male or three female HanIbm: WIST (SPF) rats, were treated with FAT 41024/B at 2000 mg/kg by oral gavage.

The test article was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administred at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15.

Mortaliy/Viability were reccorded together with clinical signs at the same time intervals. Body weight were recorded on day 1 prior to administartion and on day 8 and 15.

All animals were necropsied and examined macroscopically.

No deaths occured during the study.

No clinical signs of toxicity were observed during the study period.

The body weight of the animals was within the range commonly recorded for animals of this strain and age.

No macroscopic findings were observed at necropsy.

In conclusion, The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured. LD50 is greater than 2000 mg/kg.