Registration Dossier
Registration Dossier
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EC number: 604-349-5 | CAS number: 143382-03-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Toxicity screening report, limited information given only; no data on GLP compliance, no guideline mentioned. However, basic information given; sufficient for a classification decision.
Data source
Reference
- Reference Type:
- other: acute toxicity screening report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- The test material was dosed as a dispersion in corn oil. The test material was administered at dosage rates of 10000, 5000 and 2500
mg/kg of body weight by oral gavage. No further information given. - GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 5-methoxymethyl-2,3-pyridine-dicarboxylic acid
- IUPAC Name:
- 5-methoxymethyl-2,3-pyridine-dicarboxylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 161-252g
- Fasting period before study: Approximately 18 hours prior to dosing.
- Housing: Suspended stainless steel wire cages with automatic watering.
- Diet (e.g. ad libitum): Purina Rodent Chow #5001 available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 10000, 5000 and 2500 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- at 10000 mg/kg bw, 2 of 5 animals died; at 5000 mg/kg bw, 2 of 5 animals died; at 2500 mg/kg bw, no animal died.
- Clinical signs:
- other: 10,000 mg/kg bw: Diarrhea, prostration, decreased respiration, and ano-genital staining. 5,000 mg/kg bw: Decreased activity, diarrhea, lacrimation, and ano-genital staining. 2,500 mg/kg bw: none observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, 5-methoxymethyl-2,3-pyridine-dicarboxylic acid does not need to be classified for acute oral toxicity according to Regulation (EC) No. 1272/2008 and according to Directive 67/548/EEC.
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