Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Details about the material and methods are not provided.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
no

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:
no data

Test animals

Species:
other: guinea pigs and rabbits
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on exposure:
no data
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
30 applications
Frequency of treatment:
no data
No. of animals per sex per dose:
no data
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
hyperemia and edema followed by desquamation, appearance of scabs, fissures ad abrasions.
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
The adverse effects included hyperemia and edema followed by desquamation, appearance of scabs, fissures and abrasions. However, after applications were stopped, these effecst were fully reversible and the guine pigs regained their weight.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
After repeated exposure, dibutyl maleate was skin irritanting but the skin was fully recovery after stopping the applications.
Executive summary:

Repeated dermal applications of dibutyl maleate induced skin irritation which underwent to fully recovery after the applications were stopped.