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

Endpoint summary

Description of key information

Oral (Rat, GLP): LD50 > 2000 mg/kg [Schering AG, Report No. draft, 1993-06-03]

Dermal (Rat, GLP): LD50 > 200 mg/kg < 2000 mg/kg [Schering AG, Report No. draft, 1994-07-06]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1993 to April 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

physiological saline

Doses:

2000 mg/kg

No. of animals per sex per dose:

3/sex

Control animals:

yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Gross pathology:

no findings

no compound-related findings observed in neither hematology nor clinical observation nor body weight .

Interpretation of results:

GHS criteria not met

Conclusions:

Since LD50> 2000 mg/kg, there is no classification required.

Executive summary:

The single oral administration of the test substance (ZK 91248) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Tamip diacetat in rats is above 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch score 2

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Principles of method if other than guideline:

combined acute dermal toxicity and local irritation study

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

occlusive

Duration of exposure:

24 hours

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

3/sex/group

Control animals:

yes, concurrent vehicle

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

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.

No compound-related findings were observed in hematology.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The test item shows acute dermal toxicity and has to be classified.

Executive summary:

The single dermal administration of Tamip diacetat to male and female rats in the doses of 200 and male rats in the dose of 2000 mg/kg results at high dose in clinical signs such as apathy, lateral position, retarded respiration and eyelid closure. Two male rats died. LD50 > 200 mg/kg

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

> 200 - < 2 000 mg/kg bw

Quality of whole database:

Klimisch score 2

Additional information

 

 

The single oral administration of the test substance (ZK 91248) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Tamip diacetat in rats is above 2000 mg/kg body weight. (Schering AG, Report No. draft, 1993-06-03)

 

The single dermal administration of Tamip diacetat to male and female rats in the doses of 200 and male rats in the dose of 2000 mg/kg results at high dose in clinical signs such as apathy, lateral position, retarded respiration and eyelid closure. Two male rats died. LD50 > 200 mg/kg (Schering AG, Report No. draft, 1994-07-06), The LD50 is therefore between 200 and 2000 mg/kg but is assumed to be close to 2000 mg/kg.

Justification for classification or non-classification

Based on the available data the substance does not need to be classified with regard to acute oral toxicity but has to be classified for acute dermal toxicity Cat. 4 (H312) according to Regulation (EC) No. 1272/2008 (CLP).