Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study, published in peer reviewed literature, restrictions in design and/or reporting.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Concentrations of hydrocarbons in tissues as a measure of toxicity,
Author:
Shugaev B
Year:
1969
Bibliographic source:
Arch. Environ. Health, 18, 878-882.

Materials and methods

Principles of method if other than guideline:
Method: other
GLP compliance:
no
Remarks:
predates GLP
Test type:
other: LC50s but no method details
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
1,3-Butadiene (source and purity not specified)

Test animals

Species:
other: rat and mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not given

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
not specified
Vehicle:
other: air
Details on inhalation exposure:
Described as "dynamic flow exposure"
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
>= 2 h
Remarks on duration:
Rats were exposed for 4h mice were exposed for 2h
Concentrations:
Specific concentrations not given
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
see below
Statistics:
see below

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
285 other: mg/L air (285, 000 mg/m3)
Exp. duration:
4 h
Remarks on result:
other: rat
Sex:
not specified
Dose descriptor:
LC50
Effect level:
270 other: mg/L (270,000 mg/m3)
Exp. duration:
2 h
Remarks on result:
other: mice
Mortality:
None
Clinical signs:
Not determined
Body weight:
Not determined
Gross pathology:
Not determined
Other findings:
none

Any other information on results incl. tables

Rat LC50 (4 hr) = 285 mg/L; confidence limits 219 -370 mg/L (p<0.05).
Mouse LC50 (2 hr) = 270 mg/L; confidence limits 251-290 mg/L (p<0.05).

Toxic effects are described in Shugaev, B.B. (1968), Farmakol. Toksikol. (Moscow) 31,162-165. There was a rapid onset of narcosis. This was reversible, after 30min withdrawal from treatment all animals returned to normal. At lethal concentrations breathing become shallower, rarer and periodic.  

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This is an old non-guideline study that is not up to current standards, but there are few acute toxicity studies available on 1,3-butadiene. However LC50s were reported to be 285 mg/L for 4h (285,000 mg/m3) in rats, 270 mg/L for 2h (270,000mg/m3) in mice.
Executive summary:

Rats and mice were exposed to 1,3-butadiene for 4h or 2h respectively. There was a rapid but reversible onset of narcosis. LC50 values were reported to be 285 mg/L (285,000 mg/m3) in rats and 270 mg/L (270,000 mg/m3) in mice.