5-amino-2,4,6-triiodoisophthalic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1990

Reliability:

1 (reliable without restriction)

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Only a limit test at 2000 mg/kg was carried out

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

yes

Remarks:

Only a limit test at 2000 mg/kg was carried out

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-2,4,6-triiodoisophthalic acid

EC Number:

252-575-4

EC Name:

5-amino-2,4,6-triiodoisophthalic acid

Cas Number:

35453-19-1

Molecular formula:

C8H4I3NO4

IUPAC Name:

5-amino-2,4,6-triiodobenzene-1,3-dicarboxylic acid

Details on test material:

Test substance was stored at room temperature in the dark in a closed cabinet.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female Sprague-Dawley rats from BRL (Switzerland) were used. The average weight of the animals at the beginning of the treatment was 200 g +/- 10% for males and 180 g +/- 10% for females.
Rats were housed by groups of 2 or 3 of the same sex in Makrolon type III cages. The animal room was located in the B building (basement) of Battelle-Geneva.
Except for the periods of starvation as defined in the protocol, rats received food 8kliba, Kaiseraugst, ref. 24-343) and water (tap water, from a water bottle) ad libitum.
Rats were placed on a sawdust bedding in their cages.
Animals were identified individually with an ear tattoo. The animal numbers were sequential.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

and distilled water

Details on dermal exposure:

The test substance was prepared as follows for dermal application:
For each animal the quantity of solid test substance was weighed in order to obtain a dose of 2000 mg/kg according to the body weight measured just before treatment.
Each dose of test substance was mix in a mortar with 100 mg of carboxy-methyl-cellulose (CMC) then the mixture was moistened with distilled water in order to obtain a semi-fluid paste to ensure good contact with the skin.
The paste was applied on the shaved skin of the back of the rats and covered with a porous gauze dressing and a non-irritating tape for 24 hours.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined every day post treatment for clinical observation and they were individually weighed once a week during the observation period and terminal body weights were recorded at necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy findings

Statistics:

The only statistical analyses which were performed are ANOVA t-tests on body weights between the treated groups and the room control to verify whether the growth curve of the animals is affected by the treatment. The results of these statistical analyses are stored in the Study Archives with the raw data.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at 2000 mg/kg

Clinical signs:

other: Transient redness of the skin after application in both sexes and hyperexcitability in females for 3 to 5 days, then recovery thereafter.

Gross pathology:

Presence of a mass on left uterine horn in 1 female, not related to treatment. No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

There were no evidence of acute dermal toxicity after performing the clinical test.