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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to OECD guideline 403
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl maleate
EC Number:
203-328-4
EC Name:
Dibutyl maleate
Cas Number:
105-76-0
Molecular formula:
C12H20O4
IUPAC Name:
dibutyl but-2-enedioate
Details on test material:
Dibutylmaleinat, dibutyl maleate, K. Nr.: 215 7135
Supplier: Chemie Linz GmbH
Impurities: unknown

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source - Commercial supplier Sprague-Dawley (Him:OFA)

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
The mass mediated diameter of the test substance aerosol was 2.7 µm. 80% of the mass was in the fraction with a diameter of less than 5 µm. Upon analysis of the test material, it was determined that the actual mean concentration of dibutyl maleate was 4690 mg/m3 which is 95% of the target concentration.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
By spectrophotometric detection of phenolred at 564 nm and verified by HPLC analysis.
Duration of exposure:
ca. 4 h
Concentrations:
5000 mg/m3 in aerosol
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Statistics:
no data

Results and discussion

Preliminary study:
No adverse effects.
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 000 mg/m³ air
Remarks on result:
other: no data on confidence limits
Mortality:
All animals survived.
Clinical signs:
other: No related observations were noted during and after the treatment period.
Body weight:
No relevant changes as compared to untreated animals.
Gross pathology:
Changes were observed on the lungs of four males and three females and recorded as "small hemorrhages."
Other findings:
No differences were oberved between male and female rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 was determined to be greater than 5000 mg/m3 (in aerosol)
Executive summary:

The potential toxic effects of dibutyl maleate were assessed in an acute inhalation test according to the OECD guideline 403. Animal were exposed to the test substance via nose-only for 4 hour at a concentration of 5000 mg/m3. All animals survived the test. No behavioral observations were made during and after the treatment period. At necropsy during the macroscopic examination, changes identified as "small hemorrhages" were noted on the lungs of four males and three females. The LC50 was determined to be greater than 5000 mg/m3 (in aerosol).