Lanolin, hydroxylated

Density

Administrative data

Endpoint:

density, other

Remarks:

density

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints.

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

differential scanning calorimetry

Key result

Melting / freezing pt.:

> 32 - < 59 °C

Atm. press.:

101 hPa

		Temperature (°C)
Thermal Event	Interpretation	Determination 1	Determination 2
Endotherm	Melting range	31.91 to 58.81	32.00 to 58.86

The melting transition of the test item was considered to be softening over a broad range.

Conclusions:

The melting temperature of the test item has been determined to be over the range 32 to 59 °C (305 to 332 K).

Executive summary:

The Melting/Freezing Point was determined to be over the range 32 to 59 °C (305 to 332 K), by differential scanning calorimetry, designed to be compatible with Method A.1 Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Cross-reference 2

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints.

Reference

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.2 (Boiling Temperature)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling Point)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

differential scanning calorimetry

Key result

Atm. press.:

101 kPa

Decomposition:

yes

Decomp. temp.:

155 °C

Thermographic Data

		Temperature (°C)
Thermal Event	Interpretation	Determination 1	Determination 2
Exotherm	Approximate onset of decomposition	154.66	160.83

Atmospheric pressure: 101 kPa

After heating to 400 °C, the samples had lost approximately 64% of their original weight.

Overall result: decomposition from approximately 155 °C (428 K)

As a result of the low rate of enthalpy change during decomposition, the onset temperature could only be approximated. Two further thermograms were run for additional information. These showed that after being heated to 150 °C and 300 °C they had lost none and 7% of their original weight respectively. The appearance of the residue after being heated to 150 °C was similar to that of the original test item; this also suggested that decomposition had not occurred up to 150 °C.

Conclusions:

The test item has been determined to decompose from approximately 155 °C (428 K) at 101 kPa. As the test item decomposed, no value for boiling temperature could be determined.

Executive summary:

Decomposition from approximately 155 °C (428 K) at 101 kPa by differential scanning calorimetry, designed to be compatible with Method A.2 Boiling Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 103 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. As the test item decomposed, no value for boiling temperature could be determined.

Cross-reference 3

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints.

Reference

Endpoint:

surface tension

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.5 (Surface Tension)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 115 (Surface Tension of Aqueous Solutions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

ring method

Key result

Surface tension:

> 70.8 - < 71.8 mN/m

Temp.:

21.3 °C

Conc.:

0.1 g/L

Readings, times and temperatures for the sample solutions:

SAMPLE 1:

Time (mins)	Reading (mN/m)	Temperature (°C)
74	71.5	21
114	71.5	21.2
124	71.5	21.2
134	71.5	21.4
144	71.5	21.4

SAMPLE 2:

Time (mins)	Reading (mN/m)	Temperature (°C)
246	71	21.4
256	71	21.4
266	71	21.4
276	71	21.6
286	71	21.6

Mean Sample 1 result : 71.5 mN/m

pH of Sample 1 : 5.8

Mean Sample 2 result : 71.0 mN/m

pH of Sample 2 : 5.6

Overall result : 71.3 ± 0.5 mN/m

Overall temperature : 21.3 ± 0.5 °C

Conclusions:

The surface tension, of solutions prepared at nominally 0.1 g/L of test item in water and diluted to 90 % saturation, has been determined to be 71.3 mN/m at 21.3 ± 0.5 °C. The test item was considered to be not surface-active.

Executive summary:

The surface tension of the test substance was determined to be 71.3 ± 0.5 mN/m at 21.3 ± 0.5 °C (for solutions prepared at nominally 0.1 g/L of test item in water and diluted to 90% saturation), using a ring method designed to be compatible with Method A5 Surface Tension of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 115 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The test item was considered to be not surface-active.

Cross-reference 4

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints.

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

0.016 g/L

Conc. based on:

test mat.

Loading of aqueous phase:

100 mg/L

Incubation duration:

22 h

Temp.:

20 °C

pH:

5.9

Details on results:

Preliminary Test: The preliminary estimate of water solubility at 20.0 ± 0.5 °C was determined to be less than 2.86 x 10-2 g/L. The solution had a pH of 5.5.
Main Test: Overall concentration: less than 1.64E-02 g/L at 20.0 ± 0.5 °C

The concentration (g/L) of four test item components in the sample solutions at 20.0 ± 0.5 °C are shown in the following table:

Sample Number	Time Shaken at ~ 30 °C (hours)	Time Equilibrated at 20 °C (hours)	Concentration (g/L)	Solution pH
1	24	24	1.64E-02	5.9
2	48	24	1.40E-02	5.9
3	72	24	1.34E-02	5.9

Conclusions:

The water solubility of the test item has been determined to be less than 1.64E-02 g/L at 20.0 ± 0.5 °C based on selected components. It was considered that the water solubility of the test item as a whole would be less than 1E-03 g/L.

Executive summary:

The water solubility of the test substance was less than 1.64E-02 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. It was considered that the water solubility of the test item as a whole would be less than 1E-03 g/L.

Cross-reference 5

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints.

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 March 2016 to 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.8 (Partition Coefficient - HPLC Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

HPLC method

Partition coefficient type:

octanol-water

Analytical method:

high-performance liquid chromatography

Key result

Type:

log Pow

Partition coefficient:

> 10

Temp.:

40 °C

pH:

5.5

Details on results:

Overall log10 Pow: >10.0 Overall
Partition coefficient: >1.0E+10

Partition coefficient of sample: The retention times, capacity factor and log10 Pow value determined for the sample:

Injection	Retention Time (mins)	Capacity Factor (k')	Log10 k'	Log10 Pow	Mean Log10 Pow
1	≥85.513	>58.6	>1.77	>10.0	>10
2	≥85.527	>58.6	>1.77	>10.0

Conclusions:

The partition coefficient of the test item has been determined to be >1.0E+10 with a log10 Pow of >10.0.

Executive summary:

The Partition Coefficient (n-octanol/water) was determined to be greater than 1.0E+10, log10 Pow of >10.0, using the HPLC method, designed to be compatible with Method A.8 Partition Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.3 (Relative Density)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 109 (Density of Liquids and Solids)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

pycnometer method

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin, hydroxylated

EC Number:

270-315-8

EC Name:

Lanolin, hydroxylated

Cas Number:

68424-66-8

IUPAC Name:

Lanolin, hydroxylated

Test material form:

solid

Dynamic viscosity of test material:

Due to the test item’s viscosity, it was considered that the pycnometer method for liquids would be impractical. Therefore, it was decided to melt and transfer the test item into glass vessels which would fit inside the sample cell of the gas comparison pycnometer. The samples were then equilibrated to 20 °C. Two determinations were performed to ensure a reproducibility of less than ± 20 kg/m3 was obtained.

Results and discussion

Density

Density 1

Key result

Type:

density

Density:

963 kg/m³

Temp.:

20 °C

Density 2

Key result

Type:

relative density

Density:

0.963

Temp.:

20 °C

Any other information on results incl. tables

Mass of the vessel, vessel and test item, and the calculated mass of test item

Determination	Mass of Vessel (g)	Mass of Vessel and Test Item (g)	Mass of Test Item (g)
1	30.8952	67.049	36.1538
2	31.7775	69.9526	38.175

Pressure readings obtained for the vessel and vessel containing test item:

Determination	Replicate	Vessel			Vessel and Test Item
		P1(sample) (psig)	P2(sample) (psig)	Volume (cm³)	P3(sample) (psig)	P4(sample) (psig)	Volume (cm³)
1	A	17.282	6.953	14.1	17.242	8.312	51.4
	B	17.262	6.942	14	17.265	8.332	51.6
	C	17.228	6.928	14	17.247	8.326	51.7
2	A	17.237	6.945	14.4	17.23	8.423	54.1
	B	17.339	6.986	14.4	17.195	8.405	54
	C	17.208	6.933	14.4	17.296	8.454	54

Calculated volumes and density:

Determination	Mean Volume of Vessel (cm³)	Mean Volume of Vessel and Test Item (cm³)	Volume of Test Item (cm³)	Density (kg/m³)
1	14	51.6	37.6	963
2	14.4	54	39.6	964

Overall mean density : 963 kg/m³

Relative density : 0.963

Temperature : 20.0 ± 1.0°C

Applicant's summary and conclusion

Conclusions:

The density of the test item has been determined to be 963 kg/m³ at 20.0 ± 1.0 °C and a relative density of 0.963.

Executive summary:

The test substance density was determined to be 963 kg/m³ at 20.0 ± 1.0 °C and a relative density of 0.963, by gas comparison pycnometer, designed to be compatible with Method A.3 Relative Density of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 109 of the OECD Guidelines for Testing of Chemicals, 02 October 2012.