Registration Dossier
Registration Dossier
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EC number: 210-913-8 | CAS number: 625-84-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Oral Toxicity (LD50) Study in the Rat with 2,5-Dimethylpyrole
- Author:
- G.A. Burdock, R.A. Ford
- Year:
- 1 984
- Bibliographic source:
- Journal of the American College of Toxicology, Vol 1, 1990, page 6
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,5-dimethyl-1H-pyrrole
- EC Number:
- 210-913-8
- EC Name:
- 2,5-dimethyl-1H-pyrrole
- Cas Number:
- 625-84-3
- Molecular formula:
- C6H9N
- IUPAC Name:
- 2,5-dimethyl-1H-pyrrole
- Reference substance name:
- 2,5-Dimethylpyrrole
- IUPAC Name:
- 2,5-Dimethylpyrrole
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were fasted 18 hours prior to dosing.
Water was freely available at all times.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The dimethylpyrole was prepared in corn oil in a range of concentrations such that administered volumes did not exceed 10 ml/kg of body weight of the animal.
- Doses:
- single dose by gavage, dose levels: 0,025; 0,053; 0,11; 0,24; 0,50 g/kg
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose group
- Control animals:
- not specified
- Details on study design:
- Animals were observed for pharmacotoxic signs at 1, 3, and 6 hours after treatment and twice daily for the remainder
of the 14-day observation period. Individual body weights were recorded immediately prior to dosing, on day 8 and at
sacrifice. All survivors at day 15 were killed via CO2 asphyxiation and gross necropsies were carried out. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 59 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 30 - ca. 88
- Mortality:
- Dose group 0,025 g/kg: no mortality
Dose group 0,053 g/kg: 1 male, 1 female (day 5)
Dose group 0,11 g/kg: 5 male, 5 female (male days 2-6, female day 2)
Dose group 0,24 g/kg: 5 male, 5 female (day 2)
Dose group 0,5 g/kg: 5 male, 5 female (day 2) - Clinical signs:
- Clinical signs included decreased activity, ataxia, gasping, nasal discharge, lacrimation, inguinal fur staining, diarrhea, salivation and death.
- Body weight:
- A decrease in mean body weight was noted on day 8 for female rats treated at 0.025 and 0.053 g/kg and male rats treated at 0.025 g/kg.
An increase in mean body weight was noted for male rats treated at 0.053 g/kg body weight on day 8 and for all surviving rats on day 14. - Gross pathology:
- Gross abnormalities of the lungs and large quantities of serous fluid in the thoraic cavity were observed at necropsy.
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- A LD50 of 59 mg/kg body weight was found in an acute oral study in Sprague-Dawley rats (male/female, single gavage administration, 14 days observation period) with 2,5-Dimethylpyrrole.
- Executive summary:
A LD50 of 59 mg/kg body weight was found in an acute oral study in Sprague-Dawley rats (male/female, single gavage administration, 14 days observation period) with 2,5-Dimethylpyrrole.
Clinical signs included decreased activity, ataxia, gasping, nasal discharge, lacrimation, inguinal fur staining, diarrhea, salivation and death.
Gross abnormalities of the lungs and large quantities of serous fluid in the thoraic cavity were observed at necropsy.
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