Registration Dossier

Administrative data

Description of key information

Acute Oral:

In an acute oral toxicity study with male Wistar rats, the LD50 of turpentine oil (CAS 8006-64-2) was determined to be 4.6 ml/kg (equivalent to ca. 4000 mg/kg) with 95% confidence limits of 3.9-5.6 ml/kg. Clinical signs were slight ataxia and lethargy. No abnormalities were detected at necropsy.

Acute Dermal:

In an acute dermal toxicity study with New Zealand White rabbits, the LD50 of turpentine oil (CAS 8006-64-2) was determined to be >2000 mg/kg. No adverse clinical signs were reported, although local irritant effects were noted. No necropsy findings were reported.

Acute Inhalation:

In an acute vapour inhalation study with male rats, the LC50 of turpentine oil (CAS 8006-64-2) was determined to be 13.7 mg/l. Clinical signs reported were convulsions and apnea; increase in respiratory rate and decrease in tidal volume. No treatment-related necropsy findings were detected.

In addition to these key data for the registration substance, reliable acute oral, dermal and inhalation toxicity studies are reported in ECHA dissemination dossiers for a number of individual constituents of TOPP. In all cases other than dimethyl disulfide and methanethiol, the reported LD50 values exceed cut-offs for classification for acute toxicity according to Regulation (EC) No 1272/2008. In the majority of these studies no treatment-related effects were noted. The data indicate that the terpene constituents are not expected to contribute to the acute toxicity profile of TOPP. The sulfur-containing constituents are discussed below.

Sulfur-containing constituents of TOPP

TOPP contains low concentrations of the sulfur-containing substances methyl mercaptan (methanethiol, typically 0.06%), dimethyl sulfide (typically 1.2%) and dimethyl disulfide (0.32%). The maximum total combined concentration of these constituents reported in commercial samples is 6% by weight expressed as sulfur.

Neither dimethyl sulfide nor dimethyl disulfide is classified for acute toxicity in Annex VI of EC Regulation 1272/2008/EC. However, the available acute oral and inhalation studies that are reported for dimethyl disulfide are consistent with classification as Acute Toxic 4 for the oral route, and Acute Toxic 3 for the inhalation route. A proposal for harmonised classification published on ECHA’s website confirms this conclusion ( https://echa.europa.eu/harmonised-classification-and-labelling-previous-consultations/-/substance-rev/16703/term?_viewsubstances_WAR_echarevsubstanceportlet_SEARCH_CRITERIA_EC_NUMBER=210-871-0&_viewsubstances_WAR_echarevsubstanceportlet_DISS=true).

Methyl mercaptan (methanethiol, CAS 74-93-1) has a harmonised classification for acute inhalation toxicity (Category 3) in Annex VI of Regulation (EC) No 1272/2008.

At the concentrations present in TOPP, the contribution of acute inhalation toxicity to the mixture would not exceed the cut-offs for the existing "Harmful by inhalation" or "Acute Toxicity Category 4" classification for the whole substance according to the rules for mixtures outlined in Regulation (EC) No 1272/2008/EC.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
Not reported
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
Not reported
Doses:
5 g/kg
No. of animals per sex per dose:
10M
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: frequently on day of exposure, once daily thereafter

- Necropsy of survivors performed: no
Statistics:
None
Sex:
male
Dose descriptor:
LD50
Effect level:
< 5 000 mg/kg bw
Based on:
test mat.

Six deaths occurred during the study. The following signs were observed: slight ataxia, lethargy and death overnight.

Interpretation of results:
GHS criteria not met
Conclusions:
All animals died at the dose level of 5000 mg/kg. While this is above the EU cut off limit for classification, it is not possible to base classification decision on this result alone.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No information on housing conditions of animals, body weight of animals not recorded during the study
Reason / purpose:
reference to other study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
no information on housing conditions of animals, body weight of animals not recorded during the study
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 140-200 g


Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass cylinder
- Exposure chamber volume: 42 mm * 30 cm
- Pressure in air chamber: 3 mm of water

TEST ATMOSPHERE
- Brief description of analytical method used: 0.4-0.5 mL of sample were withdrawn with a gas-tight syringe and injected into a hydrogen-flame gas chromatograph.
- Samples taken from breathing zone: yes




Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 1 - 6 h
Concentrations:
- 12.6-15.7; 15.8-19.8; 19.9-25.0 and 25.1-31.5 mg/L for 1 hour exposure
- 18-22 mg/L (2 hours exposure); 15-19 mg/L (4 hours exposure) and 7; 8-9; 10-11 and 13-17 mg/L (6 hours exposure)
No. of animals per sex per dose:
10-19 animals per concentration
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 1 week
- Frequency of observations: Turpentine concentration in rat tissue was determined after 15, 30, 60 mins and 2 hours after exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ-body weight ratio, distribution and concentration of turpentine in tissues
Statistics:
All LC50 calculations were done by the Litchfield-Wilcoxon (1949) method.
Preliminary study:
Not applicable
Sex:
male
Dose descriptor:
LC50
Effect level:
13.7 mg/L air (nominal)
Based on:
test mat.
95% CL:
>= 11.1 - <= 14.8
Exp. duration:
4 h
Mortality:
- 8.3% (at 12.6-15.7mg/L); 25.0% (at 15.8-19.8mg/L); 92.3% (at 19.9-25.0mg/L) and 90.0% (at 25.1-31.5 mg/L) at 1 hour exposure of turpentine concentration
Clinical signs:
other: Convulsions and apnea; increase in respiratory rate and decrease in tidal volume
Body weight:
No data
Gross pathology:
Organ body-weight and lesions noticed in lungs were similar in type and extent to those found among controls

Other findings:
- Lung concentrations were higher 30 minutes after 1 and 2 hours after exposure, than after 15 minutes. All tissues, except lung, followed a typical exponential decay curve
- Brain and spleen had the highest concentrations immediately and 60 minutes after exposure

Table 1: Results of a single 1-hour exposure of rats to different concentrations of turpentine vapor

Range of concentrations (mg/L)

Logarithm of difference within range

Mean of range

Logarithm of difference between means

mortality (%)

12.6-15.7

0.1

14.5

8.3

15.8-19.8

0.1

17.1

0.072

25

19.9-25.0

0.1

21.9

0.107

92.3

25.1-31.5

0.1

27.7

0.101

90

 Table 2: Summary of LC50s for rats for various periods of exposure to turpentine vapor

Duration of exposure (hours)

LC50 (mg/L)

Fiducial limits (mg/L)

Slope

Fiducial limits

1

16.9

17.5-22.7

1.24

1.12-1.36

2

16.6

15.9-17.9

1.19

1.12-1.26

4

13.7

11.1-14.8

1.23

1.12-1.35

6

11.7

10.6-12.7

1.21

1.11-1.32

 

Table 3: Concentration of turpentine in tissues of rats at various intervals after a 1-hour or a 2-hour exposure to vapor of turpentine

Tissue

Mean recovery (%)

Concentration after 1 hour exposure (µg/g)

Concentration after 2 hour exposure (µg/g)

Zero time

15 min

30 min

60 min

Zero time

15 min

30 min

60 min

 Brain 

 25 

 160 

 63 

 49 

 20 

 127 

 47 

 21 

 15 

 Spleen 

 50 

 214 

 127 

 39 

 19 

 94 

 32 

 15 

 17 

 Kidney 

 35 

 146 

 58 

 26 

 0 

 97 

 26 

 8 

 12 

 Liver 

 15 

 167 

 43 

 33 

 0 

 157 

 34 

 17 

 8 

 Lung 

50

 101 

 0 

 26 

 0 

 54 

 20 

 25 

 7 

 Blood 

 65 

 24 

 16 

 8 

 1 

 4 

 0.4 

 0.7 

 0.9 

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the test conditions, the inhalation LC50 for turpentine was found to be 13.7 mg/L/4 hours in rats and therefore it is classified as “R20 Harmful by inhalation” according to the annex VI of the Directive 67/548/EEC and category 4 according to the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In an inhalation acute toxicity study performed following a method similar to OECD guideline 403, groups of male rats (10-19/concentration) were exposed to turpentine vapors at concentrations of 12.6-15.7; 15.8-19.8; 19.9-25.0 and 25.1-31.5 mg/L for 1 hour, 18-22 mg/L for 2 hours, 15-19 mg/L for 4 hours and 7; 8-9; 10-11 and 13-17 mg/L for 6 hours. Surviving animals were then observed for mortality and clinical signs of toxicity for one week and were all macroscopically necropsied which included measurement of organ-bodyweight ratios and distribution and concentration of turpentine in tissues.

 

8.3, 25, 92.3 and 90% mortalities were observed when animals were exposed to turpentine vapors for 1 hour at various concentrations of 12.6-15.7, 15.8-19.8, 19.9-25.0 and 25.1-31.5 mg/L, respectively. Deaths were always preceded by convulsions and sudden apnea but these were not always followed by death. Increase in respiratory rate and decrease in tidal volume were noticed in exposed animals. Tissue distribution of turpentine in rats showed that brain and spleen had the highest concentrations immediately and 60 minutes after exposure. Organ body-weights and lesions noticed in lungs were similar in type and extent to those found among controls. The 4 hours LC50 for turpentine vapors was calculated to be 13.7 mg/L.

 

Under the test conditions, the inhalation LC50 for turpentine was found to be 13.7 mg/L/4 hours in rats and therefore it is classified as “R20 Harmful by inhalation” according to the annex VI of the Directive 67/548/EEC and category 4 according to the CLP Regulation (EC) N° (1272-2008).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
13 700 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24h
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

No animals died during the course of the study. No evidence of toxicity from percutaneous absorption of the test material. Moderate erythema was present in 1 animal and slight erythema in 8 animals on day one, which was completely reversible in all animals by day 5. Moderate edema was present in one animal on day one and slight edema in 4 animals, all effects reversible by day 3. All animals were essentially normal by the termination of the study. No abnormalities were noted at necropsy.

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study in New Zealand White rabbits, the LD50 was >2000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

TOPP

Acute toxicity studies for the oral, inhalation and dermal administration routes are available for turpentine oil. Very few details are available regarding test conditions and, for the oral and dermal data, no guideline was followed. The studies pre-date GLP and they were therefore assigned Klimisch reliability score 2. No information is available on the composition of the test substance.

In the key acute oral study (Moreno, 1972a), groups of 10 male Wistar rats were dosed with turpentine oil diluted in water at dose levels of 3.2, 4.0. 5.0 or 6.25 ml/kg. There were mortalities at all dose levels (1/10, 4/10, 6/10 and 8/10 respectively). Clinical signs were slight ataxia and lethargy. No abnormalities were detected at necropsy. The LD50 was determined to be 4.6 ml/kg, which is equivalent to ca. 4000 mg/kg.

In addition to studies on the substance itself, limited data are available for an essential oil, nutmeg oil. Nutmeg oil consists predominantly (80-90%) of bicyclic terpene C10H16hydrocarbons {α-pinene (20-25%), β-pinene (15-18%) and sabinene (38-42%)}. In a standard oral acute toxicity study (not conducted in compliance with GLP) in the rat, the LD50 of nutmeg oil was≥2200 and ≤3120 mg/kg (bw) (Jenner et al., 1964).

In an inhalation acute toxicity study performed following a method similar to OECD guideline 403, groups of male rats (10-19/concentration) were exposed to turpentine vapours at concentrations of 12.6-15.7; 15.8-19.8; 19.9-25.0 or 25.1-31.5 mg/l for 1 hour, 18-22 mg/l for 2 hours, 15-19 mg/l for 4 hours and 7; 8-9; 10-11 or 13-17 mg/l for 6 hours. Surviving animals were then observed for mortality and clinical signs of toxicity for one week and were all macroscopically necropsied which included measurement of organ-bodyweight ratios and distribution and concentration of turpentine in tissues. 8.3, 25, 92.3 and 90% mortalities were observed when animals were exposed to turpentine vapours for 1 hour at various concentrations of 12.6-15.7, 15.8-19.8, 19.9-25.0 and 25.1-31.5 mg/l, respectively. Deaths were always preceded by convulsions and sudden apnoea but these were not always followed by death. Increase in respiratory rate and decrease in tidal volume were noticed in exposed animals. Tissue distribution of turpentine in rats showed that brain and spleen had the highest concentrations immediately and 60 minutes after exposure. Organ body-weights and lesions noticed in lungs were similar in type and extent to those found among controls. The 4 hours LC50 for turpentine vapours was calculated to be 13.7 mg/l.

In the only available acute dermal study (Moreno, 1972c), 10 New Zealand White rabbits were exposed to turpentine oil for 24 hours under occlusive conditions at a dose level of 2000 mg/kg. There were no mortalities, clinical signs or treatment-related necrospy findings. The LD50 (dermal) is therefore >2000 mg/kg.

Constituents

Available information on the acute toxicity of constituents of TOPP is summarised in the following sections. Where original study reports could be obtained, robust study summaries are also included.

Terpineol

Studies for the oral and dermal administration routes are available for the mixed isomers of the constituent terpineol (CAS 8000-41-7) which is typically present in TOPP at 0-1% (α-terpineol, CAS 98-55-5) and 0-5% (β-terpineol, CAS 138-87-4). No information is available in the study report regarding the isomeric ratio in the test material used in the oral study. In the dermal study, the test material consisted of approximately 59.5% α-terpineol, 6.5% cis-β-terpineol, 2% trans-β-terpineol, 8% γ-terpineol and 0.5% δ-terpineol, total 76% terpineols.

An acute oral toxicity study (limit test) with test substance Terpineol multiconstituent was conducted in 10 Sprague-Dawley OFA rats (5 males and 5 females) following OECD Test Guideline 401 (EVIC CEBA, 1998). The test substance was administered undiluted through oral gavage at the single dose of 2000 mg/kg bw. Animals were observed for clinical signs at least once a day for 14 days. Body weights were taken just before dosing and at days 4, 8 and 15.

Piloerection and a decrease in motor activity and in muscular tonus were observed in all animals for the first 6 h after dosing. All effects were reversed at day 3 except for one female, found dead at day 2. In this female, congestions in the lungs, liver, spleen and kidneys were observed. Stomach and intestines were bloated by gas. In the other animals, no particular finding was identified at necropsy. Bodyweight increase throughout the study was normal. The LD50 was >2000 mg/kg bw.

In the acute dermal toxicity study 2000 mg/kg bw of undiluted test material was applied onto the intact skin of 5 male and 5 female rats and kept in contact with the skin under semi-occlusive dressing (Phycher-Biodevelopment, 2006). The animals were observed for 14-days. Clinical signs of toxicity were noted daily. Body weights were recorded prior to dosing, then on days 2, 7 and 14. At the end of the study period the animals were sacrificed and macroscopic observations were performed.

No deaths occurred during the 14 -day observation period. No clinical signs of toxicity or changes in body weight gain were observed during the study period. No macroscopic changes were noted in any of the animals at pathological examinations. The reported LD50 value was greater than 2000 mg/kg bw.

α-Pinene (CAS 80-56-8)

Acute oral and dermal toxicity studies were reported for α-pinene under the USEPA HPV programme.

For the oral route, ten male rats per dose were administered 0, 2020, 3200, 5000 and 7800 mg/kg bw alpha-pinene. Mortalities at each dose level were: 2020 mg/kg bw, 2/10; 3200 mg/kg bw, 5/10; 5000 mg/kg bw, 6/10; 7800 mg/bw, 9/10. The animals experienced diarrhoea and urinary incontinence. Deaths occurred from 2 hours after administration to 2 days following.  The LD50 calculated from the data was 3700 mg/kg bw (Moreno, 1972d, cited in USEPA High Production Volume Information System).

For the dermal route, a single 24 hour application was made to the clipped abraded abdominal skin of ten male New Zealand White rabbits. There were no deaths and the LD50 was reported to be >5000 mg/kg bw (Moreno, 1972e, cited in USEPA High Production Volume Information System)

 

β-Pinene (CAS 127-91-3)

Acute oral (rat) and dermal (rabbit, 24 hour application) LD50values >5000 mg/kg bw are reported for β-pinene (TOXNET). An oral (rat) value of 4700 mg/kg bw is also reported published sources (Lewis, 2004). No further details are available.

 

Terpinolene/Iso terpinolene (CAS 586-62-9)

In an acute oral toxicity study (similar to OECD Guideline No 401), 10 rats/dose were given a single oral dose of terpinolene monoconstituent at 3.0, 3.5, 4.0 or 5.0 ml/kg bw. Animals were then observed for mortality and clinical signs of toxicity. No clinical signs were observed. Deaths occurred at 3.5 ml/kg bw and above. The oral LD50 for terpinolene monoconstituent is 4.39 mL/kg bw in rats, corresponding to about 3.74 g/kg bw (TOXNET).

In an acute dermal toxicity study (similar to OECD Test Guideline 402), four rabbits were administered a single dose of terpinolene monoconstituent at 5 ml/kg bw. All animals were observed for mortality and clinical signs of toxicity. No mortality occurred at the tested dose level. The acute dermal LD50 of terpinolene monoconstituent was considered to be higher than 5 ml/kg bw. As the density of the test item is 0.860 g/cm3, then the LD50 is higher than 4.3 g/kg bw (TOXNET). 

Trans-Anethole (CAS 4180-23-8)

In a standard oral acute toxicity study (not conducted in compliance with GLP) in the rat, the LD50 of trans-anethole was ≥1420 and ≤3070 mg/kg (bw). In a standard oral acute toxicity study in guinea pigs the LD50was ≥ 1920 ≤ 2450 mg/kg (bw). In mouse, the LD50was ≥ 2330 ≤ 4000 mg/Kg (bw) (Jenner et al., 1964).

Under the conditions of the acute dermal toxicity study in rabbits, trans-anethole (4900 mg/kg bw) produced no deaths. It can therefore be assumed that the acute dermal LD50value is above 4900 mg/kg bw in rabbits (REACH dissemination dossier[1]).

The dissemination dossier also reports an acute aerosol inhalation toxicity study according to OECD Test Guideline 403 and in compliance with GLP reported an LC50 >5.1 mg/m3for male and female Wistar rats.

Alpha-Terpineol (CAS 98-55-5)

An acute oral (mouse) LD50 value of 2830 mg/kg bw is reported in the REACH dissemination dossier for alpha-terpineol[2]. The result was obtained from a non-guideline study. No other acute toxicity studies were reported for this constituent.

p-Cymene (4-isopropyl-1-methyl benzene)

In a standard oral acute toxicity study (not conducted in compliance with GLP) in the rat, the LD50 of p-cymene was≥3720 and ≤6060 mg/kg (bw) (Jenner et al., 1964).

Fenchone

In a standard oral acute toxicity study (not conducted in compliance with GLP) in the rat, the LD50 of fenchone was≥4400 and ≤8630 mg/kg (bw) (Jenner et al., 1964).

 

Dimethyl disulfide (CAS 624-92-0)

The REACH dissemination dossier for dimethyl disulfide [3] reports a number of acute oral toxicity studies. The key study in rats was conducted in accordance with OECD Test Guideline 423 (Acute Toxic Class method) and resulted in an oral LD0 >300 mg/kg bw which, in combination with other reported results, is consistent with classification as Category 4 for acute oral toxicity according to Regulation (EC) No 1272/2008. Supporting studies are available which are in agreement with this conclusion for classification and labelling.

One reliable acute dermal toxicity study and several studies of unassigned reliability are reported. The reliable study, conducted in accordance with the OPPTS 870.1200 (August 1998) guideline, concluded that the acute dermal LD50 (rat) was >5000 mg/kg bw. Other studies were consistent with a conclusion of no classification for acute dermal toxicity according to Regulation (EC) No 1272/2008.

An acute vapour inhalation toxicity study in rats was conducted in accordance with the OPPTS 870.1300 guideline. The reported LC50 (4 hour) was 1310 ppm, equivalent to approximately 5 mg/l. A proposal for harmonised classification of dimethyl disulfide includes classification as Category 3 for acute inhalation toxicity.

Methanethiol (CAS 74-93-1)

The REACH dissemination dossier [4] reports an acute inhalation toxicity study in rats for methanethiol, conducted according to a method similar to OECD Test Guideline 403. The 4 hour LC50 for methanethiol in the rat was 675 ppm (1.33 mg/l), which is consistent with classification as Category 3 for acute inhalation toxicity according to Regulation (EC) No 1272/2008.

Dimethyl sulfide (CAS 75-18-3)

The REACH dissemination dossier [5] reports an acute oral toxicity study in rats for dimethyl sulfide, conducted according to OECD Test Guideline 423. There were no deaths and the LD0 is reported as >2000 mg/kg bw.

In an acute inhalation toxicity study in rats, conducted according to a method similar to OECD Test Guideline 403. The 4 hour LC50 was reported as 102 mg/l.

[1] Accessed 21st November 2016

[2] Accessed 1st November 2016

[3] Accessed 7th November 2016

[4] Accessed 7th November 2016

References:

Moreno O.M. (1972d) Acute oral toxicity in rats. Unpublished report to RIFM.

Moreno O.M. (1972e) Acute dermal toxicity of alpha-pinene in rabbits. Unpublished report to RIFM.

TOXNET citing The Flavor and Fragrance High Production Volume Consortia; Revised Robust Summaries for Bicyclic Terpene Hydrocarbons Submitted to the EPA under the HPV Challenge Program. p.141 (November 9, 2006).

Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3099

TOXNET citing EPA/Office of Pollution Prevention and Toxics; High Production Volume (HPV) Challenge Program's Robust Summaries and Test Plans for Monoterpene Hydrocarbons (May 2002).

Justification for classification or non-classification

Turpentine (CAS 8006-64-2) has a harmonised classification in Annex VI of Regulation 1272/2008/EC as follows:

According to the criteria of EU Directive 67/548/EEC: Xn; R20/21/22 "Harmful by inhalation, in contact with skin or if swallowed" and R65 "Harmful: may cause lung damage if swallowed".

According to the criteria of 1272/2008/EC: Acute Toxic Category 4 (oral, dermal and inhalation) and Aspiration Toxicity Category 1.

The available in vivo acute inhalation toxicity data for turpentine and its constituents support these official classifications. The results of the available acute oral and dermal studies do not agree with the official classification. However, in view of the limitations in quality of these studies, the official classification is adopted.