Carbazamidine monohydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

study conducted on the analogue substance; The Reliability of the Source Study is 2.

Justification for type of information:

The read across justification is detailed in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

10 male Wistar rats/ group received single doses of the test item by gavage and were observed for clinical signs and mortality for 14 days standard acute method

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: 5 per cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

10 male Wistar rats/ group received single doses by gavage and were observed for clinical signs and mortality for 14 days.

Doses:

3100, 5000 mg/kg bw

No. of animals per sex per dose:

10 males/group

Control animals:

no

Details on study design:

10 male Wistar rats/ group received single doses by gavage and were observed for clinical signs and mortality for 14 days.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: In the 5000 mg group 4/10 animals died: sedation and poor general condition

Mortality:

No animal died in the 3100 mg/kg bw group.
4/10 animals died within 2 to 6 days in the 5000 mg/kg bw group.

Clinical signs:

3100 mg/kg bw animals tolerated treatment without impairment
5000 mg/kg bw 10 /10: sedation, poor general condition

Body weight:

no details

Gross pathology:

no details

Applicant's summary and conclusion

Interpretation of results:

other: not classified as toxic or harmful according to the CLP Regulation (EC) No. 1272/2008

Conclusions:

The LD50 (oral) was found to be be greater than 5000 mg/kg bw.

Executive summary:

Groups of 10 male Wistar rats received single oral doses (3100 or 5000 mg/kg bw) of the test item dissolved in water and were observed for 14 days. Rats dosed with 3100 mg/kg bw tolerated the treatment without clinical signs or mortality. All 10 rats dosed with 5000 mg/kg bw showed sedation and poor general condition within 2 to 6 days after application of the test item, 4/10 died.

Therefore, the LD50 (oral) is > 5000 mg/kg bw.