Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401), with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

EC Number:

281-339-3

EC Name:

Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

Cas Number:

83929-47-9

Molecular formula:

C15H10Cl2N2O5

IUPAC Name:

methyl 4-[(2,5-dichlorophenyl)carbamoyl]-2-nitrobenzoate

Details on test material:

- Name of test material (as cited in study report): Nitro-MMT-Dichloranilid-25 TF8

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: male: approx. 7 weeks; female: approx. 8 weeks
- Weight at study initiation: males mean: 189 g; females mean: 184 g
- Fasting period before study: yes (about 16 h before and 3-4 h after dosing)
- Housing: in Makrolon cages (Type 4) in groups of 5
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- fully air-conditioned rooms
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

limit dose: 2000 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 weighing: weekly
- Frequency of observations: twice every day/weekends and holidays only once
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 524 mg/kg bw

Remarks on result:

other: no animals died within the observation period; 2000 mg/kg bw of the test substance correspond to 1524 mg/kg bw of the submission substance

Mortality:

- no deaths occurred

Clinical signs:

other: - no signs of toxicity observed

Gross pathology:

- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

Single oral application of the limit dose of 2000 mg test substance per kg bw (corresponding to 1524 mg submission substance per kg bw) did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 1524 mg/kg bw.

Executive summary:

Male and female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the limit dose of 2000 mg/kg bw (corresponding to 1524 mg submission substance per kg bw): No animal died during the 14 day observation period, resulting in a LD50 > 1524 mg/kg bw.