Benzoic acid, 3-amino-5-[[[2,3-bis(acetyloxy)propyl]amino]carbonyl]-2,4,6-triiodo-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to April 1994

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion (comparable to OECD TG 402 and 404). The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint. As described in ATP 96/54/EC ANNEX IV A, PART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS, a strategy of testing for irritancy allows the non-performance of a test if an acute toxicity study by the dermal route has been conducted at the limit test dose with the substance (method B.3), and no skin irritation was observed, further testing for skin irritation (method B.4) may be unnecessary.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid

EC Number:

602-891-7

Cas Number:

122731-59-3

Molecular formula:

C15 H15 I3 N2 O7

IUPAC Name:

rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid

Test animals

Species:

rat

Strain:

Wistar

Test system

Type of coverage:

occlusive

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3/sex/dose

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

At 2000 mg/kg (3 male rats exposed) clinical signs such as apathy, lateral position, retarded respiration and eyelid closure were observed. Two male rats died. Only one male rat survived and therefore mean irritation score could not be determined.

No compound-related findings were observed in hematology.

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since the test substance was tolerated without any local skin irritation, classification is not required

Executive summary:

The single dermal administration of Tamip diacetate to male and female rats in the doses of 200 mg/kg and male rats of 2000 mg/kg results at high dose in clinical signs in all male rats. Two male rat died. The female animals were without any clinical signs. The test substance was tolerated without any local skin irritations.