5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-aminium chloride

Appearance / physical state / colour

Administrative data

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 11, 2016 - January 3, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 11, 2016 - January 3, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 (Particle size analysis by laser diffraction)

Version / remarks:

Handbook K, 2007

Principles of method if other than guideline:

According to REACH Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in regulation (EC) No 440/2008. OECD 110 TG ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

Relative density: 1.22

Mass median aerodynamic diameter:

30.467 µm

Geometric standard deviation:

>= 2.415 - <= 2.433

Remarks on result:

other: MMAD is the mean (n= 5) value. 'St.dev.' in table below is the population standard deviation [µm].

Key result

Percentile:

D10

Mean:

8.436 µm

St. dev.:

0.043

Key result

Percentile:

D50

Mean:

27.583 µm

St. dev.:

0.13

Key result

Percentile:

D90

Mean:

177.825 µm

St. dev.:

8.403

No.:

#1

Size:

< 10 µm

Distribution:

12.87 other: vol%

Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.

VISUAL OBSERVATION

The substance was observed to be a medium to fine white powder with lumps and clusters. Using 3.2 objective lens under a microscope, the particles appeared to be crystalline needles and fibres. Using 40 objective lens under a microscope, the sample was observed to be made up of agglomerated crystalline particles.  

Conclusions:

Particle size distribution of the substance: D10 = 8.436 µm, D50 = 27.583 µm and D90 = 177.825 µm. 12.87% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 30.467 µm.

Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (small volume wet module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. D10 = 8.436 µm, D50 = 27.583 µm and D90 = 177.825 µm. 12.87% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 30.467 µm.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Appearance was determined by visual observation.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2R)-5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-amine hydrochloride

Cas Number:

93601-85-5

Molecular formula:

C14H21NO.HCl

IUPAC Name:

(2R)-5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-amine hydrochloride

Constituent 2

Reference substance name:

(2S)-5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-amine hydrochloride (1:1)

EC Number:

695-797-0

Cas Number:

93601-86-6

Molecular formula:

C14H21NO.HCl

IUPAC Name:

(2S)-5-methoxy-N-propyl-1,2,3,4-tetrahydronaphthalen-2-amine hydrochloride (1:1)

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: White to off-white powder
- Storage condition of test material: At room temperature

Results and discussion

Physical state at 20°C and 1013 hPa:

solid

Form / colour / odour

Key result

Form:

solid: particulate/powder

Colour:

white

Odour:

other: not determined

Substance type:

organic

Applicant's summary and conclusion

Conclusions:

The substance is a white powder.

Executive summary:

The substance is a solid. The substance was visually observed to be a medium to fine white powder with lumps and clusters.