Registration Dossier
Registration Dossier
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EC number: 941-122-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 2,6-dimethylpyridinium chloride and 3-methylpyridinium chloride and 4-methylpyridinium chloride
- EC Number:
- 941-122-2
- Molecular formula:
- not yet assigned
- IUPAC Name:
- Reaction mass of 2,6-dimethylpyridinium chloride and 3-methylpyridinium chloride and 4-methylpyridinium chloride
- Test material form:
- other: liquid
- Details on test material:
- Test substance contains 60.6 % pyridine hydrochloride and 22.5 % hydrochlorid acid, liquid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd/Win:WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: healthy young adult animals
- Weight at study initiation: males mean: 150.4 g ± 20 %, females mean: 129.8 g ± 20 %
- Fasting period before study: overnight
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/10 cm3
- Amount of vehicle (if gavage): 10 cm3/kg bw
- Justification for choice of vehicle: to prevent strong corrosivity
- Purity: pure - Doses:
- 200 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at 0.5, 1, 2, 3, 4, 5 and 6 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at all dose levels.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- At autopsy no deviations from normal morphology were found.
Any other information on results incl. tables
At 200 mg/kg no mortality, no clinical symptoms, no macroscopic organ changes.
Because of the corrosive properties and the low pH mortality is expected at
higher dose levels that were not tested for human reasons.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In this acute oral toxicity study in the rat a combined LD50 value of > 200 - 2000 mg/kg bw was derived.
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