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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:
1984
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
2,5-Dimethylpyrrole
IUPAC Name:
2,5-Dimethylpyrrole
Test material form:
not specified
Details on test material:
no data

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.