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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets general acceptable standards with limited data but sufficient to judge the results as reliable with restrictions to support REACH registration.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1949

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Similar to one day cuff method of Draize et al (J Pharmac exp Therap. 82-377, 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) maleate
EC Number:
205-524-5
EC Name:
Bis(2-ethylhexyl) maleate
Cas Number:
142-16-5
Molecular formula:
C20H36O4
IUPAC Name:
bis(2-ethylhexyl) but-2-enedioate
Constituent 2
Chemical structure
Reference substance name:
Dioctyl maleate
EC Number:
220-835-6
EC Name:
Dioctyl maleate
Cas Number:
2915-53-9
Molecular formula:
C20H36O4
IUPAC Name:
dioctyl but-2-enedioate
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Area of exposure: fur removed from entire truck area by clipping
% coverage
Type of wrap if used: impervious plastic film

Other:
Animals immobilized during exposure period
Duration of exposure:
24 hours
Doses:
not specified
No. of animals per sex per dose:
4
Control animals:
other: no but a large number of other substances also tested which acted as reference
Details on study design:
Duration of observations period follwing administration: 14 days
Statistics:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
15 mL/kg bw
Based on:
test mat.
Mortality:
No data given on doses used or mortalities at respective dose levels. No available information on times of death, symptoms or findings during necropsy.
Clinical signs:
other: No information on symptoms
Gross pathology:
No information on findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 of 15 ml/kg (14000 mg/kg) was determined.
Executive summary:

In an acute dermal toxicity study in rabbits in which basic information was reported, an LD50 of 15 ml/kg was determined. Results indicate that the substance is not acutely toxic by dermal route.