Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-05-27 to 2014-07-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other:
Remarks:
Study performed according to recognized international guidelines and GLP. No deviation from the guidelines was observed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in a cool, dry and well ventilated place and away from foodstuffs. In darkness at room temperature.
- Stability under test conditions: Yes
- Solubility and stability of the test substance in the solvent/vehicle: Slighthly soluble in water 33.9 mg/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Reacts with strong acids

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

Remark: Environmental precautions: Do not allow to enter drains or waterways.
Do not discharge into the subsoil/soil
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: NIPPONT AUTOMOTIVE COATINGS Co. Ltd.
- Expiration date of the lot/batch: 5C12AA
- Purity test date: 96%STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In darkness at room temperature
- Solubility and stability of the test substance in the solvent/vehicle:
SOLUBILITY IN WATER(20℃) : Dispersible in water.
SOLVENT SOLUBILITY : Soluble in MeOH,EtOH,Xylene,Toluene
- Stability under test conditions:
STABILITY :Stable under normal temperature and pressure.
CONDITION TO AVOID :May burn but does not ignite readily.Flammable poisonous
gases may accumulate in tanks and hopper cars.
May ignite combustible (wood,paper,oil,etc.).
INCOMPATABILITIES :OXIDIZERS(STRONG)- Fire and explosion hazard.
HAZARDOUS :Thermal decomposition products may include toxic oxides
DECOMPOSITION of carbon and nitrogen.
POLYMERIZATION :Hazardous polymerization has not been reported to
occur under normal temperatures and pressures.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING: According to the requirements of the Guideline

FORM AS APPLIED IN THE TEST (if different from that of starting material)Not different from the form applied of starting material.

Results and discussion

Water solubility
Key result
Water solubility:
ca. 33.9 mg/L
Conc. based on:
test mat.
Incubation duration:
>= 24 h
Temp.:
20 °C
pH:
>= 2
Remarks on result:
other: No deviation

Any other information on results incl. tables

Result of the Preliminary Test (non-GLP): One preliminary test for the water solubility was carried out. The solubility of the test item was estimated by visual solubility testing described in the guidelines. The water solubility of the test item was estimated to be 86 mg/L. In accordance with the guideline the shake flask method was used for the performance of the main test.

- Result of the Main Test: The water solubility results in pure water showed no tendency to increase, therefore the study is considered to be valid. Corresponding to the analysis the water solubility of the Lauric Condensate LE was determined to be 33.9 mg/L in pure water.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L) The water solubility of the test item was determined to be 33.9 mg/L in pure water.
Executive summary:

The water solubility of the test item was measured with the flask method according to OECD Guideline 105, EU Method A.6, EPA OPPTS 830.7840 and GLP. No deviation from the guidelines was observed during the test.

The water solubility of the test item was determined to be 33.9 mg/L in pure water.