Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Turpentine Oil from Pulping Processes (TOPP) consist of terpenes, mainly bicyclic monoterpenes such as alpha- and beta-pinene and delta-3-carene, and lower concentrations of monocyclic monoterpenes, it is a volatile oil extracted from various tree species
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

TOPP is a UVCB substance; it consists of a mixture of terpenes, mainly consisting of bicyclic monoterpenes such as α- and β-pinene and δ-3-carene, monocyclic monoterpenes (e.g. dipentene) and sesquiterpenes.

A key issue for the risk assessment of UVCB substances is the possibility that even though the substance has passed a ready biodegradability test, it might contain some persistent (‘P’) or very persistent (‘vP’) constituents. Furthermore, some of these constituents could be bioaccumulative (‘B’) or very bioaccumulative (‘vB’), or toxic (‘T’). Therefore, the possibility that some ‘vPvB’ or ‘PBT’ constituents are present in the substance is investigated.

The REACH Regulation requires that registered substances are evaluated to determine whether they have properties that confer on them the status of being of “very high concern (sVHC)” or, in the cases of UVCB substances, whether they contain any constituents identified as such at a concentration of >0.1%.

It should be noted that some samples of TOPP may differ in composition to the one considered in detail here.

Based on the available information on the constituents present in TOPP, it can be concluded that none of the constituents fulfil the criteria of PBT or vPvB.

Table 8.1.1: BIOWIN predicted persistence assessment for constituents of TOPP

Constituents

BIOWIN 2: Non-linear model

BIOWIN 3 (Ultimate)

BIOWIN 6: MITI non-linear model

Persistence assessment

Block

Alpha Pinene

0.3432

2.686

0.3302

not P

1

α- Fenchene

0.3432

2.686

0.3865

not P

1

Tricyclene

0.0853

2.4739

0.3855

not P

1

P-Cymene

0.9052

2.7529

0.4353

not P

1

Beta Pinene

0.3432

2.686

0.3865

not P

1

Delta-3-Carene

0.3432

2.686

0.3302

not P

2

Terpinolene

0.7454

2.8981

0.3518

not P

3

Myrcene

0.7454

2.8981

0.4162

not P

3

Terpinene

0.7454

2.8981

0.2852

not P

3

Iso-terpinolene

0.7454

2.8981

0.3518

not P

3

γ- Terpinene

0.7454

2.8981

0.2852

not P

3

Dipentene

0.7454

2.8981

0.3312

not P

3

alpha-Phellandrene

0.7454

2.8981

0.2216

not P

3

β-Phellandrene

0.7454

2.8981

0.2669

not P

3

Dimethyl sulfide

0.8934

3.0619

0.6837

not P

4

Methyl mercaptan

0.911

3.0929

0.7607

not P

5

Sesquiterpenes (Gamma murolene)

0.5267

2.7476

0.0588

not P

6

Delta Cadinene

0.5267

2.7476

0.0641

not P

6

alpha Cadinene

0.5267

2.7476

0.0588

not P

6

1,4-Cineole

0.0023

2.4254

0.4177

not P

7

1,8-Cineole

0.0023

2.4254

0.4105

not P

7

Fenchone

0.0451

2.416

0.5988

not P

7

Camphor

0.0451

2.416

0.5988

not P

7

Terpinen-1-ol

0.288

2.6462

0.3032

not P

7

Fenchol

0.1809

2.594

0.5947

not P

7

Terpinen-4-ol

0.288

2.6462

0.3032

not P

7

beta-Terpineol

0.288

2.6462

0.297

not P

7

Methyl Chavicol

-2.1045

3.1992

0.5077

not P

7

Isoborneol

0.1809

2.594

0.5947

not P

7

alpha-Terpineol

0.288

2.6462

0.297

not P

7

Borneol

0.1809

2.594

0.5947

not P

7

cis-Anethole

0.959

2.8135

0.5365

not P

7

trans-Anethole

0.959

2.8135

0.5365

not P

7

Camphene

0.3432

2.686

0.3865

not P – but measured data indicate not biodegradable and therefore P or vP

8

Dimethyl disulfide

0.8417

2.991

0.4614

not P

9

Table 8.1.2: KOWWIN and BCF QSAR predicted bioaccumulation assessment for constituents of TOPP

Constituents

log Kow*

Predicted BCF

Bioaccumulation assessment

Block

Alpha Pinene

4.3

850

Not B

1

α- Fenchene

4.4

990

Not B

1

Tricyclene

4.1

650

Not B

1

P-Cymene

4.0

500

Not B

1

Beta Pinene

4.4

990

Not B

1

Delta-3-Carene

4.6

1700

Not B

2

Terpinolene

4.9

2800

B

3

Myrcene

4.9

2800

B

3

Terpinene

4.8

2200

B

3

Iso-terpinolene

4.9

2800

B

3

γ- Terpinene

4.8

2200

B

3

Dipentene

4.8

2500

B

3

alpha-Phellandrene

4.6

1700

Not B

3

β-Phellandrene

4.7

2000

B

3

Dimethyl sulfide

0.9

1.0

Not B

4

Methyl mercaptan

0.78

1.0

Not B

5

Sesquiterpenes (Gamma murolene)

6.3

40000

vB

6

Delta Cadinene

6.3

41000

vB

6

alpha Cadinene

6.3

40000

vB

6

1,4-Cineole

3.1

90

Not B

7

1,8-Cineole

3.1

90

Not B

7

Fenchone

3.0

80

Not B

7

Camphor

3.0

80

Not B

7

Terpinen-1-ol

3.3

140

Not B

7

Fenchol

2.9

53

Not B

7

Terpinen-4-ol

3.3

140

Not B

7

beta-Terpineol

3.4

160

Not B

7

Methyl Chavicol

3.5

180

Not B

7

Isoborneol

2.9

53

Not B

7

alpha-Terpineol

3.3

140

Not B

7

Borneol

2.9

53

Not B

7

cis-Anethole

3.4

150

Not B

7

trans-Anethole

3.4

150

Not B

7

Camphene

4.4

990

Not B

8

Dimethyl disulfide

1.9

8.0

Not B

9

* The log Kow values presented here are rounded to two significant figures

Table 8.1.3: Predicted NOECs for constituents of TOPP

Constituent

CAS No

Predicted water solubility (mg/L)

Predicted long-term NOEC fish (mg/L)**

Predicted long-term NOEC invertebrate (mg/L)**

Predicted NOEC algae (mg/l)**

T assessment

Bioaccumulation assessment

Persistence assessment

Block

Alpha Pinene

80-56-8

5.7

0.13

0.13

0.53

Not T

Not B

not P

1

α- Fenchene

471-84-1

4.9

0.11

0.11

0.48

Not T

Not B

not P

1

Tricyclene

508-32-7

7.5

0.17

0.16

0.64

Not T

Not B

not P

1

P-Cymene

99-87-6

34

0.21

0.20

0.76

Not T

Not B

not P

1

Beta Pinene

127-91-3

4.9

0.11

0.11

0.48

Not T

Not B

not P

1

Delta-3-Carene

13466-78-9

2.9

0.066

0.070

0.33

Not T

Not B

not P

2

Terpinolene

586-62-9

1.7

0.039

0.044

0.23

Not T

B

not P

3

Myrcene

123-35-3

1.7

0.039

0.044

0.23

Not T

B

not P

3

Terpinene

8013-00-1

2.2

0.050

0.055

0.27

Not T

B

not P

3

Iso-terpinolene

586-62-9

1.7

0.039

0.044

0.23

Not T

B

not P

3

γ- Terpinene

99-85-4

2.2

0.050

0.055

0.27

Not T

B

not P

3

Dipentene

7705-14-8

1.9

0.043

0.048

0.24

Not T

B

not P

3

alpha-Phellandrene

99-83-2

2.9

0.065

0.069

0.33

Not T

Not B

not P

3

β-Phellandrene

555-10-2

2.4

0.055

0.060

0.29

Not T

B

not P

3

Dimethyl sulfide

75-18-3

22000

41

18

25

Not T

Not B

not P

4

Methyl mercaptan

74-93-1

29000

42

18

24

Not T

Not B

not P

5

Sesquiterpenes (Gamma murolene)

30021-74-0

0.050

0.0038

0.0060

0.050

T

vB

not P

6

Delta Cadinene

483-76-1

0.050

0.0035

0.0055

0.046

T

vB

not P

6

alpha Cadinene

29350-73-0

0.050

0.0038

0.0060

0.050

T

vB

not P

6

1,4-Cineole

470-67-7

210

1.4

1.0

2.9

Not T

Not B

not P

7

1,8-Cineole

470-82-6

330

1.4

1.0

2.9

Not T

Not B

not P

7

Fenchone

1195-79-5

73

1.6

1.2

3.3

Not T

Not B

not P

7

Camphor

76-22-2

190

1.6

1.2

3.3

Not T

Not B

not P

7

Terpinen-1-ol

586-82-3

340

0.92

0.71

2.2

Not T

Not B

not P

7

Fenchol

512-13-0

460

2.3

1.6

4.3

Not T

Not B

not P

7

Terpinen-4-ol

562-74-3

390

0.92

0.71

2.2

Not T

Not B

not P

7

beta-Terpineol

138-87-4

290

0.78

0.62

2.0

Not T

Not B

not P

7

Methyl Chavicol

140-67-0

84

0.67

0.54

1.8

Not T

Not B

not P

7

Isoborneol

124-76-5

400

2.3

1.6

4.3

Not T

Not B

not P

7

alpha-Terpineol

98-55-5

670

0.92

0.71

2.2

Not T

Not B

not P

7

Borneol

507-70-0

1200

2.3

1.6

4.3

Not T

Not B

not P

7

cis-Anethole

104-46-1

98

0.78

0.62

2.0

Not T

Not B

not P

7

trans-Anethole

4180-23-8

98

0.78

0.62

2.0

Not T

Not B

not P

7

Camphene

79-92-5

4.9

0.11

0.11

0.48

Not T

Not B

not P – but measured data indicate not biodegradable and therefore P or vP

8

Dimethyl disulfide

624-92-0

3100

9.8

5.4

(predicted)

0.0025 measured withDaphnia magna

(ECHA 2013h)

10

T

Not B

not P

9

**>Water solubility indicates that the value is significantly above the water solubility of the constituent

Likely routes of exposure:

TOPP and its constituents do not meet the criteria for PBT; therefore, emission characterisation is not required.