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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of testmaterial (as cited in study report): 1,2-Dimethylimidazol
Substance number: 77/683

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF-Zucht, Firma MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +/- 15 g
- Diet: Herilan MRH (Firma H. Eggersmann, Rinteln/Weser), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Aerosol generation: generated using a continuous infusion pump to lead the water/substance mixture (50%) through a two-fluid nozzle with compressed air
-Tubes in which the snout extends into an inhalation chamber for exposure
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
3.01 mg/l (analytical), 19.59 mg/l (nominal)
2.39 mg/l (analytical), 15.33 mg/l (nominal)
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight
Statistics:
The statistical analysis of the experiment was based on the binomial test by the computational center at BASF.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
12 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: conversion of the 4-h LC50 according to the Haber-rule
Sex:
male
Dose descriptor:
LC50
Effect level:
3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
12 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: conversion of the 4-h LC50 according to the Haber-rule
Sex:
female
Dose descriptor:
LC50
Effect level:
3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
12 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: conversion of the 4-h LC50 according to the Haber-rule
Mortality:
No mortality occured
Clinical signs:
other: Watery, reddish eyes and nasal secretions. Shock manner or rapid breathing. Long-legged, tumbling movement. Scruffy look. Matted fur. Alopecia. 2 out of 20 male animals showed nose burns. On the day of necropsy symptoms were still recorded.
Body weight:
Slight differences in body weight gain were observed in the test groups compared to the control group.
Gross pathology:
No treatment related findings.

Applicant's summary and conclusion