Registration Dossier

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:
No information on symptoms
Body weight:
No data
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.