Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The appearance of the test item is described in a reliable study report on the physical-chemical properties of the substance. Since no guideline was followed and no details on the methods are given, the description is considered as reliable with restrictions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Jun 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
no
Type of method:
differential scanning calorimetry
Remarks:
and Differential Thermo-Analysis (DTA)
Melting / freezing pt.:
> 600 °C
Decomposition:
yes
Decomp. temp.:
840 °C
Remarks on result:
other: No melting point in the temperature range 22 - 600 °C; Oxidative decomposition in an air atmosphere at 840 °C.

Results

DSC: Neither Tg (glass transition temperature) nor melting point was observed between 22 to 600 °C.

 

DTA: Neither endothermic nor exothermic peak was observed between 20 to 1000 °C in a nitrogen atmosphere. The peak due to oxidative decomposition was observed at 840 °C in an air atmosphere.

 

Conclusion

The test item has no melting point in the temperature range of 22 - 600 °C. Oxidative decomposition of the test item was occurred at 840 °C.

Conclusions:
No melting point observed in the temperature range 22-600 °C. The substance undergoes oxidative decomposition in an air atmosphere at 840 °C.
Reason / purpose:
reference to same study
Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Apr 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
GLP compliance:
no
Type of method:
determination of fibre length and diameter distributions
Remarks:
by scanning electron microscopy (SEM)
Remarks on result:
other: see "Any other information on results incl. tables"

The average of fibre length, diameter and aspect ratio (length/diameter) of the fibre in the test item (Batch No. 15-11-519) is shown in the following table:

 

 

Fibre length

Fibre diameter

Average of aspect ratio

Average

Average

D50

≤100 nm

[µm]

[nm]

[nm]

[%]

[-]

Average

5.2

148

143

18.5

35

Range

1.8-20

48-372

-

-

-

 

 

The fibres from 5 production batches, including batch No. 15-11-519, were also observed by SEM. The average and standard deviation of fibre length, diameter and aspect ratio are shown in the following table:

 

 

Fibre length

Fibre diameter

Average of aspect ratio

Average

Average

≤100 nm

[µm]

[nm]

[%]

[-]

15-09-435

3.7

152

11.0

24

15-11-519

5.2

148

18.5

35

17-01-009

4.7

146

8.0

32

17-01-034

3.8

142

21.5

27

18-02-120

4.0

161

9.0

25

Average of 5 batches

Average

4.3

150

13.6

29

SD

0.6

7

6.0

5

Min

3.7

142

8.0

24

Max

5.2

161

21.5

35

 

 

Conclusion

Two hundreds of fibre for batch No. 15-11-519 is measured for its length and diameter. The range and average of fibre length of batch No. 15-11-519 were 1.8 - 20 µm and 5.2 µm, respectively. The range and average of fibre diameter were 48 - 372 nm and 148 nm, respectively. 18.5 % of the particles had a diameter ≤100 nm. The average of the aspect ratio was 35.

The average of 5 production batches for average fibre length, average fibre diameter and average of aspect ratio were 4.3 µm, 150 nm and 29, respectively. In the 5 batches the percentage of particles ≤100 nm ranged from 8.0 % to 21.5 % (13.6 % average).

Conclusions:
The average fibre length, fibre diameter and aspect ratio were 4.3 µm, 150 nm and 29, respectively. The percentage of particles ≤100 nm ranged from 8.0 % to 21.5 % (13.6 % average).
Reason / purpose:
reference to same study
Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
02 Apr 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Determination of the specific surface area by BET
GLP compliance:
no
Type of method:
other: Brunauer, Emmet and Teller (BET) method for determination of surface area

The result of specific surface area were as follows:

Mass of dried cell (g): 10.4974

Mass of dried cell and test item after degassed (g): 10.9096

Mass of degassed test item (g): 0.4122

C constant: 64.5047

Specific surface area of test item (m²/g): 15

 

 

Conclusion

Specific surface area of the fibre in batch No. 15-11-519 was determined to be 15 m²/g.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The description of the physical state of the substance was based on a visual inspection of the substance at room temperature and normal pressure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
solid: particulate/powder
Colour:
Black
Odour:
odourless
Substance type:
inorganic

Applicant's summary and conclusion

Conclusions:
The substance is a black and odourless powder at room temperature and normal pressure.