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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline available at the study performance date.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List V
Author:
Smyth HF
Year:
1954
Bibliographic source:
Archives of Industrial Hygiene and Occupational Medicine vol 10, pp 61-68

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
method akin to the one-day cuff method of Draize 1944 (Methods of study for irritation and toxicity of substances applied topically to the skin and mucous membranes, Journal Pharmacol. Exp. Therap. 82:377).
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) fumarate
EC Number:
205-448-2
EC Name:
Bis(2-ethylhexyl) fumarate
Cas Number:
141-02-6
Molecular formula:
C20H36O4
IUPAC Name:
bis(2-ethylhexyl) but-2-enedioate
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
body weight: 2.5–3.5 kg

Administration / exposure

Details on dermal exposure:
- fur removed from the entire trunk by clipping
- dose retained beneath an impervious plastic film
- immobilisation of the animals during exposure
- observation for 14 days after the end of exposure
Duration of exposure:
24 hours
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
no data
Statistics:
LD50: method of Thompson and Weil

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50, dermal, rabbit was > 20mL per kg body weight when applied for 24 hours to the intact skin of rabbits.
Executive summary:

The test substance was applied to the intact skin of 4 male rabbits per group for 24 hours. The animals were observed for mortalities for further 14 days. The LD50, calculated according to the method of Thompson and Weil, was > 20 mL per kg body weight which is equal to 18840 mg/kg bw.