European_Chemicals_Agency_SVHC_Support_Document.pdf

SVHC SUPPORT DOCUMENT

Adopted on 26 May 2011

Substance name: Hydrazine EC number: 206-114-9 CAS number: 302-01-2

MEMBER STATE COMMITTEE

SUPPORT DOCUMENT FOR IDENTIFICATION OF

HYDRAZINE

AS A SUBSTANCE OF VERY HIGH CONCERN BECAUSE OF ITS

CMR PROPERTIES

CONTENTS

1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES

1.1 Name and other identifiers of the substance

1.2 Composition of the substance

1.3 Physico-chemical properties

2 HARMONISED CLASSIFICATION AND LABELLING

3 CONCLUSIONS ON THE SVHC PROPERTIES

3.1 PBT, vPvB assessment

3.2 CMR assessment

3.3 Substances of equivalent level of concern assessment

Substance Name(s): Hydrazine

EC Number(s): 206-114-9

CAS number(s): 302-01-2

This dossier covers the anhydrous hydrazine, EC number 206-114-9 and CAS number 302-01-2, and all its possible hydrates.

• The substance is identified as a substance meeting the criteria of Article 57 (a) of Regulation (EC) 1907/2006 (REACH) owing to its classification as carcinogen category 1B1 which corresponds to classification as carcinogen category 22

Summary of how the substance meets the CMR3 1B criteria

Hydrazine is covered by index number 007-008-00-3 of Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1 (the list of harmonised classification and labelling of hazardous substances) as carcinogen, Carc. 1B (H350: “May cause cancer”). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised and classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is carcinogen, Carc. Cat.

2, R45 (“May cause cancer”).

Therefore, this classification of the substance in Regulation (EC) No 1272/2008 shows that it meets the criteria for classification as carcinogen in accordance with Article 57 (a) of REACH.

Registration dossiers submitted for the substance? Yes

1 Classification in accordance with Regulation (EC) No 1272/2008 Annex VI, part 3, Table 3.1 List of harmonised classification and labelling of hazardous substances.

2 Classification in accordance with Regulation (EC) No 1272/2008, Annex VI, part 3, Table 3.2 List of harmonised classification and labelling of hazardous substances (from Annex I to Council Directive 67/548/EEC).

3 CMR = Carcinogenic, mutagenic or toxic for reproduction

JUSTIFICATION

1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL

PROPERTIES

1.1 Name and other identifiers of the substance

Table 1.1: Substance identity

EC number: 206-114-9

EC name: Hydrazine

CAS number (in the EC inventory): 302-01-2

1. CAS number: hydrate(s)

2. CAS number (alternate):

3. CAS number: deleted

7803-57-8

10217-52-4

119775-10-9; 75013-58-0; 78206-91-4; 31886-26-7

CAS name: Hydrazine

IUPAC name: Hydrazine

Index number in Annex VI of the CLP Regulation

007-008-00-3

Molecular formula: H4N2

Molecular weight: 32 g/mol

Synonyms: Hydrazine: H70; H70 (fuel); Levoxine; Nitrogen hydride(N2H4); Oxytreat 35, diamine

Hydrazine hydrate: hydrazine hydroxide, hydrazinium hydroxide

Structural formula:

N N

H

H

H

H

1.2 Composition of the substance

Name: Hydrazine

Degree of purity: 93 - 100 %

Table 1.2: Constituents

Constituents Typical concentration Concentration range Remarks

Hydrazine

206-114-9

93 – 100 % Based on the information received in the registration dossiers

Table 1.3: Impurities

Impurities Typical concentration Concentration range Remarks

Table 1.4: Additives

Additives Typical concentration Concentration range Remarks

1.3 Physico-chemical properties

Table 1.5: Overview of physicochemical properties (Hydrazine, CAS no 302-01-2)

Property Value Remarks

Physical state at 20°C and

101.3 kPa

Colorless liquid with an ammoniacal odor

Ullmanns Encyclopedia of Industrial Chemistry, Hydrazine, Jean-Pierre Schirmann, Paul Pourdauducq, Wiley-VCH Verlag GmbH & Co.

KHaA, Weinheim, 2005

Melting/freezing point 2.0 °C Lide, David, R., Handbook of Chemistry and Physics, 75th Edition, CRC Press, Boca Raton, Ann Arbor, London, Tokyo, 1994-1995

Boiling point 113.5 °C at 760 mmHg The Merck Index, 14th Edition, Merck & Co., Inc., Whiterhouse Station, NJ, USA, 2006

Vapour pressure 1.91 kPa at 25 °C Lide, David, R., Handbook of Chemistry and Physics, 75th Edition, CRC Press, Boca Raton, Ann Arbor, London, Tokyo, 1994-1995

Water solubility Miscible with water in all proportions

Ullmanns Encyclopedia of Industrial Chemistry, Hydrazine, Jean-Pierre Schirmann, Paul Pourdauducq, Wiley-VCH Verlag GmbH & Co.

KHaA, Weinheim, 2005

Surface tension 66.7 mN/m at 25 °C

( c = pure substance)

Ullmanns Encyclopedia of Industrial Chemistry, Hydrazine, Jean-Pierre Schirmann, Paul Pourdauducq, Wiley-VCH Verlag GmbH & Co.

KHaA, Weinheim, 2005

Partition coefficient n-octanol/water (log value) logPow = -2.07 at 25 °C ECHA, calculation according to EPISUITE performed with the module WSKOWWIN, 2011

PKa value 8.1 at 25 °C Lide, David, R., Handbook of Chemistry and Physics, 75th Edition, CRC Press, Boca Raton, Ann Arbor, London, Tokyo, 1994-1995

Viscosity 0.974 µPa.s at 20 °C

( c = pure substance)

Ullmanns Encyclopedia of Industrial Chemistry, Hydrazine, Jean-Pierre Schirmann, Paul Pourdauducq, Wiley-VCH Verlag GmbH & Co.

KHaA, Weinheim, 2005

Flash point 52 °C Lide, David, R., Handbook of Chemistry and Physics, 75th Edition, CRC Press, Boca Raton, Ann Arbor, London, Tokyo, 1994-1995

Table 1.6: Overview of physicochemical properties (Hydrazine hydrate, CAS no 7803-57- 8)

Property Value Remarks

Physical state at 20°C and

120.3 kPa

Colorless liquid RCOM, 2011

Melting/freezing point -51.7 °C RCOM, 2011

Boiling point 120.1 °C at 1013 hPa RCOM, 2011

Vapour pressure 20 hPa at 20 °C RCOM, 2011

Water solubility Miscible RCOM, 2011

Partition coefficient n-octanol/water (log value) logPow = - 3.8 RCOM, 2011

PKa value 8.1 at 25 °C RCOM, 2011

Dynamic viscosity 1.5 mPa.S at 20°C RCOM, 2011

2 HARMONISED CLASSIFICATION AND LABELLING

Hydrazine is covered by Index number 007-008-00-3 in Annex VI, part 3 of Regulation (EC) No 1272/2008 as follows:

Table 2.1: Classification according to part 3 of Annex VI, Table 3.1 ((list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008

Classification Labelling Index No Internatio nal Chemical Identificat ion

EC No CAS No

Hazard Class and Category Code(s)

Hazard state-ment code(s)

Pictogr am, Signal Word Code(s

Hazard state-ment code(s)

Suppl.

Hazar d statem ent code(s)

Spec.

Conc.

Limit s, M-factor s

Notes

007-008-00-3 HYDRAZI

NE

206-114-9 302-01-2 Flam. Liq..3

Carc. 1B

Acute Tox. 3*

Acute Tox. 3*

Acute Tox. 3*

Skin Corr. 1B

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic

H226

H350

H331

H311

H301

H314

H317

H400

H410

GHS02

GHS06

GHS08

GHS05

GHS09

Dgr

H226

H350

H331

H311

H301

H314

H317

H410

Skin Corr.

1B;

H314:

C≥ 10%

Skin Irrit.

2;

H315:

3% ≤ C< 10%

Eye Irrit.

2;

H319:

3% ≤ C < 10%

Table 2.2: Classification according to part 3 of Annex VI, Table 3.2 (list of harmonized classification and labelling of hazardous substances from Annex I of Council Directive

67/548/EEC)

INDEX NO INTERNATI

ONAL

CHEMICAL

IDENTIFICA

TION

EC NO CAS NO CLASSIFICAT

ION

LABELLING CONCENTRATION

LIMITS

NOTES

007-008-00-3 HYDRAZINE 206-114-9 302-01-2 R10

CARC. CAT.2;

R45

T; R23/24/25

C; R34

R43

N; R50-53

T; N

R: 45-10- 23/24/25-34- 43-50/53

S: 53-45-60-61

C; R34: C ≥ 10%

XI; R36/38: 3% ≤ C < 10%

E

3 CONCLUSIONS ON THE SVHC PROPERTIES

3.1 PBT, vPvB assessment

Not relevant for this dossier.

3.2 CMR assessment

Hydrazine is covered by index number 007-008-00-3 of Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1 (the list of harmonised classification and labelling of hazardous substances) as carcinogen, Carc. 1B (H350: “May cause cancer”). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised and classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is carcinogen, Carc. Cat.

2, R45 (“May cause cancer”).

Therefore, this classification of the substance in Regulation (EC) No 1272/2008 shows that it meets the criteria for classification as carcinogen in accordance with Article 57 (a) of REACH.

3.3 Substances of equivalent level of concern assessment

Not relevant for identification of SVHC in accordance with Article 57(c) of REACH.