Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material: 4-Methylpyridine

Test animals

Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young animals, not previously used for testing purposes
- Weight at study initiation: 200-300 g
- Fasting period before study: 24 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Due to the small amount of the test material required it was measured and mixed with propylene glycol prior to being intubated via a syringe and
stainless steel catheter.
Doses:
125, 250, 500, 630, 800, 1000, 2000 mg/kg bw/day
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
470 mg/kg bw
Based on:
test mat.
95% CL:
300 - 720
Sex:
female
Dose descriptor:
LD50
Effect level:
460 mg/kg bw
Based on:
test mat.
95% CL:
300 - 720
Clinical signs:
Lethargy and unkempt coats were noted in the animals dosed at levels ranging from 125 mg/kg bw - 500 mg/kg bw. Ocular hemorrhage accompanied lethargy and unkempt coats at 630 mg/kg bw and 800 mg/kg bw. Comas preceded death in the animals which succumbed. Labored breathing, comas, ocular hemorrhage, unkempt coats preceded death at levels of 1000 mg/kg bw. and 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 values for males and females were determined at 470 mg/kg bw and 460 mg/kg bw, respectively.