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

Endpoint summary

Description of key information

Dermal (Rat, GLP): non-skin irritant [Schering AG, Report No. X192, 1997-01-08]

 

Study on eye irritation waived due to low pH (1.88).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 23 to May 02, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

???

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

Specific details on test material used for the study:

formulation as paste (2000 mg/kg) and microcristalline suspension, pH 1.88 (200 mg/kg)

Species:

rat

Strain:

Wistar

Type of coverage:

occlusive

Vehicle:

physiological saline

Controls:

no

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3/sex/dose

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

The test substance was tolerated without any local skin irritation

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The single dermal administration of Tamip monoamide to male and female rats in the doses of 200 and 2000 mg/kg results at high dose in clinical signs in all male rats. One male rat died. The female animals were without any clinical signs. The test substance was tolerated without any local skin irritations. (Schering AG, Report No. X192, 1997-01-08)

Effects on eye irritation: corrosive

Justification for classification or non-classification

 

Tamip amide in aqueous suspensions is acidic (pH 1.5). Therefore, corrosive effects are expected in case Tamip monoamide is inadvertantly introduced on skin or into the eye.

Subsequently, the substance is classified as Category 1 for skin damage (despite of absent local irritation signs in the study in rats) and Category 1 for eye damage according to Regulation 1272/2008/EC (CLP) .