Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study similar to OECD 401 protocol. The study was done prior to implementation of GLPs.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylpyridine
EC Number:
203-626-4
EC Name:
4-methylpyridine
Cas Number:
108-89-4
Molecular formula:
C6H7N
IUPAC Name:
4-methylpyridine
Constituent 2
Reference substance name:
g-Picoline
IUPAC Name:
g-Picoline

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
501, 631, 794, 1,000 mg/kg
No. of animals per sex per dose:
2 or 3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
700 mg/kg bw
Based on:
test mat.
95% CL:
620 - 800
Mortality:
Rats that died prior to scheduled sacrifice did so within one to three days post dose.
501 mg/kg - 1/5
631 mg/kg - 2/5
794 mg/kg - 3/5
1,000 mg/kg - 5/5
Clinical signs:
Toxic signs included reduced appetite and activity (for one to three days in survivors), increasing weakness, ocular discharge containing blood and collapse
Gross pathology:
Autopsy findings in those rats that died prior to scheduled sacrifice included hemorrhagic lungs, liver discoloration and acute gastrointestinal
inflammation. The viscera of rats that survived the observation period appeared normal by macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information 300 < LD50 < 2000 mg/kg. Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of 3-methylpyridine in Sprague-Dawley rats was 700 mg/kg.