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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 November 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
no incidence on study quality and integrity
GLP compliance:
yes
Remarks:
quality assurance statement included

Test material

Constituent 1
Chemical structure
Reference substance name:
1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol
EC Number:
944-490-2
Molecular formula:
unknown
IUPAC Name:
1-hydroxyoctan-2-yl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12,15-trienoate; 2-hydroxyoctyl octadeca-9,12-dienoate; octane-1,2-diol
Test material form:
liquid
Specific details on test material used for the study:
Test substance is soluble at 10% in paraffin oil. Interacts with MTT and has no coloration property.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: 4-year old foreskin
Source strain:
not specified
Justification for test system used:
according to the OECD guideline
Vehicle:
other: parrafin oil
Details on test system:
Air-liquid cultivated keratinocytes (during 18 days). The following quality criteria have been reached: normal histology, correct cellular viability, integrity of barrier function, absence of HIV-1/HIV-2/HCV/HBV/mycoplasma.
Control samples:
yes, concurrent negative control
yes, concurrent vehicle
yes, concurrent positive control
Amount/concentration applied:
1% and 10 %
Duration of treatment / exposure:
42 minutes +/- 1 minute
Duration of post-treatment incubation (if applicable):
42 hours +/- 1 hour until incubation with MTT
Number of replicates:
3 replicates

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1% concentration experiment
Value:
ca. 104.7
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
10% concentration experiment
Value:
ca. 101.6
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
Validity criteria have been fulfilled, allowing to valid the results of test item.
The % tissue viability of test item at both concentrations were higher than 100% and were reduced to 100% in the conclusion so as to fit with the classification.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test substance reduces MTT in a specifically way and presents the following characteristics:
- at 1% concentration: relative viability of 100.0% meaning it is not irritant at this concentration.
- at 10% concentration: relative viability of 100.0% meaning it is not irritant at this concentration.
Executive summary:

Non irritant in vitro, OECD 439 assay on SkinEthic reconstructed human epidermis, at 1% and 10%.