1-o-tolylbiguanide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Single dose

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Performed to acute toxic class method, but only with males
Some mortality at the single dose tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-o-tolylbiguanide

EC Number:

202-268-6

EC Name:

1-o-tolylbiguanide

Cas Number:

93-69-6

Molecular formula:

C9H13N5

IUPAC Name:

1-o-tolylbiguanide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: five to eight weeks old
- Weight at study initiation: At the start of the main study the males weighed 143 to 172g, and the females 131 to 149g
- Fasting period before study:
- Housing: Solid-floor polypropylene cages furnished with woodflakes.
- Diet: Rat & Mouse Expanded Diet no. 1, Special Diets Services Limites, witham, Essex, UK
- Water: Free access to mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 46 - 63
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Doses:

- dosed once by gavage using a metal cannula attached to a graduated syringe

No. of animals per sex per dose:

5 fasted male were given a single dose

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

2 390 mg/kg bw

Mortality:

Deaths were noted one or two days after dosing

Clinical signs:

other: Ataxia, hunched posture and increased salivation with additonal signs or incidents of lethargy, ptosis, decreased respiratory rate, laboured respiration, red/brown stains around the eyes, mouth or snout and toptoe gait. Surviving animals recovered four t

Other findings:

Necropsy: Common abnormalities noted at necropsy of animals that died during the study were haemorrhage or pallor of the gastric mucosa. Slight haemorrhage of the large and/or small intestines was also noted at necropsy of animals treated with 2000 mg/kg that died during the study. Additonal abnormalities noted at necropsy of one male treated with 2000 mg/kg that died during the study were haemorrhage of the non-glandular epithelium of the stomach and slight haemorrhage of the bladder. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) and 95% confidence limits of the test material, CASAMINE OTB, in the Sprague-Dawley CD strain rat were calculated by a probit method of Finney D J to be:

Males only: 2390 (1446 - 3950 mg/kg/bodyweight)
No symbol and risk phrase required.

Test material was given evaluation number 1 according to the German Water Hazard Classification Scheme.