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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Acceptable publication which meets basic scientific principles. (Whole trunk was clipped for test substance application, only 4 animals used in test group, no data on clinical signs, mortality, body weight and gross pathology.)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth, H.F. Jr. et al.
Year:
1962
Bibliographic source:
Amer Ind Hyg Assoc J 23:95-107
Reference Type:
publication
Title:
THE PLACE OF THE RANGE FINDING TEST IN THE INDUSTRIAL TOXICOLOGICAL LABORATORY
Author:
Smyth, H.F. Jr. and Carpenter, C.P.
Year:
1944
Bibliographic source:
J Ind Hyg Toxicol. 26 (8):269-273

Materials and methods

Principles of method if other than guideline:
Rabbits were exposed dermally to the test substance for 24 hours.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) azelate
EC Number:
203-091-7
EC Name:
Bis(2-ethylhexyl) azelate
Cas Number:
103-24-2
Molecular formula:
C25H48O4
IUPAC Name:
bis(2-ethylhexyl) azelate
Details on test material:
- Name of test material (as cited in study report): Azelaic acid, di-(2-ethylhexyl)ester
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: entire trunk
- Type of wrap if used: impervious plastic film

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): up to 20 mL/kg bw

Duration of exposure:
24 hours
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- during 24 hours exposure period animals are immobilized, during observation period animals are caged
- Duration of observation period following administration: 14 days
Statistics:
LD50 value was calculated by the method of Thompson (Bacteriol. Rev. 11: 115, June 1947) using the tables of Weil (Biometrics, 8: 249, Sept. 1952).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
20 mL/kg bw
Based on:
test mat.
95% CL:
9.1 - 43.8
Sex:
male
Dose descriptor:
LD50
Effect level:
18 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: recalculated value with a density of 915 mg/mL at 25 °C (Lide, 2005)

Any other information on results incl. tables

No data on mortality or clinical signs is given, body weight and gross pathology were not covered in this study

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified