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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:
phototoxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 432 (In Vitro 3T3 NRU Phototoxicity Test)
Deviations:
no
GLP compliance:
yes
Type of method:
in vitro
Endpoint addressed:
other: phototoxicity

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:
Yellow oil, soluble at 10% (w/v) in paraffin oil.

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
not specified
Details on test animals or test system and environmental conditions:
In vitro environmental conditions:
Mouse embryo fibroblasts (3T3 balb/c) were cultured during 24h in a DMEM medium containing 4.5g/L of glucose, 4 mM of glutamine and 110 mg/mL of sodium pyruvate with 10% of newborn calf serum, 100 UI/mL of penicillin and 100 μg/mL of streptomycin. Hygrometry >90%, temperature at 37°C.

Administration / exposure

Vehicle:
paraffin oil
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
1 hour
Frequency of treatment:
not specified
Post exposure period:
18 to 22 hours post incubation period
Doses / concentrationsopen allclose all
Dose / conc.:
0.001 other: %
Dose / conc.:
0.002 other: %
Dose / conc.:
0.003 other: %
Dose / conc.:
0.006 other: %
Dose / conc.:
0.013 other: %
Dose / conc.:
0.025 other: %
Dose / conc.:
0.05 other: %
Dose / conc.:
0.1 other: %
No. of animals per sex per dose:
not applicable
Details on study design:
Positive control: chlorpromazine hydrochloride; Negative control: EBSS without Ca2+ nor Mg2+ (used to solubilize the positive control) ;Vehicule control: paraffin oil
Test substance concentrations were prepared from a 1% mother solution. Preparation was extemporaneous.
Two 96-well plates of cells were treated at 8 different concentrations of test item (100 μL/well) for 1 hour. One plate was not exposed to UVA while the other was exposed to UVA at a final dose of 5J/cm². Cells were rinsed and plates were post-incubated for 18-22 hours. Cytotoxicity was then assessed through neutral red uptake technique. Cellular viability, IC50 and PIF (photoirritation factor) were calculated.

Examinations

Examinations:
Reading of the optical densities at 540 nm to determine % of viability, then IC50 and PIF.
Positive control:
IC50 (without UVA) = 10.0 µg/mL
IC50 (with UVA) = 0.6 µg/mL
PIF = 16.7

Results and discussion

Details on results:
Validity criteria of the study were accepted.
Results for the test substance were: IC50 (without UVA) = 0.025 µg/ml and IC50 (with UVA) = 0.025 µg/ml.
The PIF (photoirritation factor), calculated from both IC50, was 1.0. According to the classification, test substance was not phototoxic.

Applicant's summary and conclusion

Conclusions:
In an OECD 3T3 NRU phototoxicity test, test substance was non phototoxic at all tested concentrations.