Registration Dossier
Registration Dossier
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EC number: 202-719-7 | CAS number: 98-98-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 May - 20 Jun 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted 08 Feb 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, England
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Pyridine-2-carboxylic acid
- EC Number:
- 202-719-7
- EC Name:
- Pyridine-2-carboxylic acid
- Cas Number:
- 98-98-6
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- pyridine-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl: CD® (SD) IGS BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 220-245 g
- Fasting period before study: Animals were fasted overnight before, and for 3 to 4 h after dosing
- Housing: groups of up to 4 animals in suspended solid-floor polypropylene cages furnished with woodflakes, and provided environmental enrichment items
- Diet: "Certified Rat Diet," not further specified, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): ≥15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 May 2008 To: 20 Jun 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: the test substance was soluble in distilled water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD:
- Rationale for the selection of the starting dose: Based on the use of available information on the toxicity of the test substance, 300 mg/kg bw was chosen as the starting dose. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 (300 mg/kg bw)
1 (2000 mg/kg bw) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed at 1/2, 1, 2 and 4 h after dosing and daily thereafter until necropsy, and individual body weights were determined on the day of dosing (before administration), and on days 7 and 14, or at death.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- A single animal was dosed initially at 300 mg/kg bw and no clinical signs or mortality were observed.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw: 0/5 females died
2000 mg/kg bw: 1/1 female died (at 4 h post-dose) - Clinical signs:
- other: 300 mg/kg bw: no clinical signs of toxicity in 5/5 animals were observed up to the end of the 14-day observation period 2000 mg/kg bw: hunched posture, lethargy, decreased respiratory rate, laboured respiration and ataxia were observed in 1/1 animals up t
- Gross pathology:
- Necropsy examination revealed no substance-related findings
Applicant's summary and conclusion
- Interpretation of results:
- other: Classification as Cat 4 H302 according to CLP Regulation (EC) No. 1272/2008 is required.
- Conclusions:
- The acute oral LD50 of test substance in female Sprague-Dawley CD rats was estimated to be in the range of 300 - 2000 mg/kg bodyweight.
CLP: Category 4. H302: Harmful if swallowed.
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