3-amino-2,4,6-triiodobenzoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 August 1998 to 16 September 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-2,4,6-triiodobenzoic acid

EC Number:

221-493-0

EC Name:

3-amino-2,4,6-triiodobenzoic acid

Cas Number:

3119-15-1

Molecular formula:

C7H4I3NO2

IUPAC Name:

3-amino-2,4,6-triiodobenzoic acid

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

other: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding: Schering AG
- Weight at study initiation: Males: 104-115 g, Females: 93-101 g
- Fasting period before study: 17.5 to 18 hours
- Housing: 1 animal per cage
- Diet (e.g. ad libitum): ad libitum 24 hours per day
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 degrees Celcius
- Humidity (%): 52 - 64%
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES:
Step 1: From: 27 August 1998 To: 09 September 1998
Step 2: From: 03 Septermber 1998 To: 16 September 1998

Administration / exposure

Route of administration:

oral: feed

Vehicle:

water

Remarks:

900 mg NaCl ad 100 ml bidist water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 Males, 3 Females

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal dies after administration of 2000 mg of the testitem per kg body weight

Clinical signs:

No clinical findings.

Body weight:

Body wieght gain was in normal range for rats.

Any other information on results incl. tables

 

Dose mg/kg	Sex	Findings	Number of animals with findings/number of surviving animals
			30 min + (Day 1)	1 hour + (Day 1)	3 hours + (Day 1)	2- 14 Days
2000	M	Apathy, slight eyelid closure, incomplete without findings	3/3	3/3	3/3 1/3 0/3	3/3
2000	F	Without findings	3/3	3/3	3/3	3/3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item in male and female rats after a single i.g. administration is > 2000 mg/kg body weight, according to OECD 432 using an oral feed route of administration.

Executive summary:

The LD50 of the test item in male and female rats after a single i.g. administration is > 2000 mg/kg body weight, according to OECD 432 using an oral feed route of administration.