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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary available

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:
secondary source
Title:
Bis(2-ethylhexyl) azelate
Author:
OECD
Year:
2006
Bibliographic source:
SIDS Initial Assessment Report for SIAM 22, Paris, France, 18-21 April, 2006

Materials and methods

Principles of method if other than guideline:
Primary skin irritation on rabbits was determined on clipped skin after application of the test item or test item solution for 24 h with a 10-grade scale.
GLP compliance:
no

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

Test system

Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
other: unchanged (no vehicle) and vehicle (water, propylene glycol or acetone) for testing solutions
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 mL
- Concentration: 100% or 0.01% solution
Duration of treatment / exposure:
24 hours
Observation period:
no data
Number of animals:
5
Details on study design:
SCORING SYSTEM:
A 10-grade scoring system was used. Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution.

Results and discussion

In vivo

Results
Irritation parameter:
other: grade of irritation
Basis:
mean
Remarks:
of all 5 animals
Time point:
other: no data
Score:
3
Max. score:
10
Reversibility:
no data
Remarks on result:
other: The exposure duration was 24 h. The scoring time point is not given.

Any other information on results incl. tables

The test substance had a grade of 3 according to the scoring system, which was applied within this study. However, it is not possible to ransfer these grading scores into Draize scores as required according to OECD guideline 404.

Applicant's summary and conclusion