Anthranilamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 1999 - 27 March 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

other: OECD 401 (LD50)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Anthranilamide

EC Number:

201-851-2

EC Name:

Anthranilamide

Cas Number:

88-68-6

Molecular formula:

C7H8N2O

IUPAC Name:

2-aminobenzamide

Test material form:

solid: particulate/powder

Remarks:

tan

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Crl:CD®(SD) IGS BR strain 205-269 g approximately 9 to 11 weeks of age

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test material was mixed with deionized water to a concentratoini of 0.4 g/mL (suspension)
An individual dose was calculated for each animal base don their fasted body weight and administered as a single gavage dose at a volume of 5 mL/kg of body weight

Doses:

single dose level of 2,000 mg/kg of bw

No. of animals per sex per dose:

5/5

Details on study design:

Clinical observations were conducted at 1, 2.5 and 4 hours after test material admnistration and daily thereafter for 14 days.
Mortality checks were conducted twice a day for 13 days and again the mornign of Day 14
Body weights were checked before administration (Day 0), at Day 7, at termination (Day 14) or at death.
All animals were subject to abbreviated macroscopic necropsy

Statistics:

No statistical evaluations were required by the protocol

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Mortality:

One male and one female treated at 2000 mg/kg died within approximately 24 hours. No other mortality was observed.

Clinical signs:

other: Clinical signs included hypoactivity, staggered gait, dyspnea, flaccidity, liquid feces and prostration. All surviving animals returned to a normal appearance by Day 1 after treatment.

Gross pathology:

There were no visible lesions observed at any of the macroscopic necropsy examinations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study conducted in the Rat under GLP, the LD50 for Anthranilamide was greater than 2000 mg/kg