Benzoyl chloride, 3-[[[2,3-bis(acetyloxy)propyl]amino]carbonyl]-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-03-24 to 1993-05-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: "New approaches to acute toxicity testing of chemicals" (Bundesgesundheitsblatt 32, pp. 336-340, 1989).

Version / remarks:

1989

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride

EC Number:

604-759-4

Cas Number:

150928-21-5

Molecular formula:

C18 H18 Cl I3 N2 O8

IUPAC Name:

rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering AG- Age at study initiation:
- Weight at study initiation: 85-92 g males; 87-104 g females
- Housing: individually under conventional conditions
- Fasting period before study: 18-19 h
- Diet (e.g. ad libitum): adlibitum: pel. Atromin R®
- Water (e.g. ad libitum): ad libitum: demineralized, acidified water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23

IN-LIFE DATES: From: 24.03.1992 To: 19.04.1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.9 g NaCl + 0.085 g Mrj ad 100 mL demin. water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1, 7 or 8 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

The single i.g. application of 2000 mg test item/kg was tolerated by all treated animals without any clinical findings. The body weight gain observed on day 7 (male) or 8 (female) and at the end of the test on day 14 was within the normal range for rats (M+F) of the age and strain which are routinely used in our laboratory. Autopsy revealed no compound-related or suspected compound-related findings.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of TIP-Diamidchlorid in male and female rats after a single i.g. application is > 2000 mg/kg body weight.

Executive summary:

In an acute oral toxicity study according to "New approaches to acute toxicity testing of chemicals" (Bundesgesundheitsblatt 32, pp. 336-340, 1989)., groups of fasted, young adult Wistar rats (3/sex) were given a single oral dose of TIP-Diamidchlorid (100% a.i.) in 0.9 g NaCl + 0.085 g Mrj ad 100 mL demin. water at a dose of 2000 mg/kg bw and observed for 14 days.

Oral LD50 Combined > 2000 mg/kg bw

No mortality occurred during this limit test.

There were no treatment related clinical signs, necropsy findings or changes in body weight.

TIP-Diamidchlorid is of LOW Toxicity based on the LD50 in both male and female rats.