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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-02-23 to 1994-03-25

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:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

As described in Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992

GLP compliance:

yes

Test type:

other: similar to Acute toxic class

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
- Weight at study initiation: Males: 84-92 g; Females: 99-102 g
- Fasting period before study: 18-19.5 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum: Pell. Altromin® R
- Water (e.g. ad libitum): ad libitum: Demineralized acidified water, pH 2-3
- Acclimation period: 7 days males; 9 days females

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 56-62

- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23.02./25.02.1994 To: 08.03./10.03.1994

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
I 194 mg test item + 0.16 mL vehicle-1)
ll 169 mg test item + 0.17 mL vehicle-1)
lll 180 mg test item + 0.18 mL vehicle-1)
IV 204 mg test item + 0.24 mL vehicle-1)
1 v 19a mg test item + 0.21 mL vehicle-1)
1 Vl 200 mg test item + 0.23 mL vehicle-1)

1) Vehicle: 0.9% (w/v) NaCl-solution

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1, 7 and 14
- Necropsy of survivors performed: no
- 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 dermal application of 2000 mg/kg of the test item was tolerated without compound-related clinical findings. The slight to moderate swelling of both forelimbs in one female animal on days 2 and 3 is not considered to be compound-related. It was probably caused by the bandage used for dermal exposure. A higher dosage than 2000 mg/kg was not tested in the present study since this dose level is established as the upper limit dose for classification and labelling requirements concerning dangerous substances in accordance with the EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations). The body weight gain observed on day 7 and at the end (day 14) of the test was within the normal range for rats (M+F) of the age and strain which are routinely used in the laboratory. On day 14 of the test all surviving animals were sacrificed without showing any compound-related clinical 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 dermal application is > 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study according to Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992 and EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations), groups of young adult Wistar rats (3/sex) were dermally exposed to TIP-Diamidchlorid (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

Dermal LD50 Combined > 2000 mg/kg bw

No mortality occurred in this limit test.

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

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