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EC number: 932-349-8 | CAS number: 8006-64-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
One study available on alpha-pinene, one main constituent of the UVCB substance, shows oral LD50 higher than 300 mg/kg bw
and lower than 2000 mg/kg bw in rats.
All studies available show dermal LD50 equal to or higher than 2000
mg/kg bw in rabbits.
One study on turpentine acute inhalation toxicity determined a LC50 of
13700 mg/m3 in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1972
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Test method and results not sufficiently detailed
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method according to the typical testing for acute oral toxicity: 10 animals/dose by oral gavage
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Diet: Ad libitum
- Water: Ad libitum - Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- No data
- Doses:
- 3.2, 4.0, 5.0 and 6.25 mL/kg bw, corresponding to approximately 2752, 3440, 4300, and 5375 mg/kg bw, respectively (based on a relative density of 0.86)
- No. of animals per sex per dose:
- 10 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed at 1 and 6 hours after dosing and daily for 14 days
- Necropsy of survivors performed: yes - Statistics:
- No data
- Preliminary study:
- No data
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 956 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 354 - <= 4 558
- Mortality:
- - 1/10 at 3.2 mL/kg bw; 4/10 at 4.0 mL/kg bw; 6/10 at 5.0 mL/kg bw and 8/10 at 6.25 mL/kg bw. corresponding to 2752, 3440, 4300, and 5375 mg/kg bw, respectively (based on a relative density of 0.86)
- Clinical signs:
- other: Slight ataxia and lethargy
- Gross pathology:
- No abnormalities
- Other findings:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for turpentine oil was found to be greater than 2000 mg/kg bw in the rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.
- Executive summary:
In an oral acute toxicity study, four groups (10/dose) of male albino Wistar rats, received oral doses of turpentine oil at 3.2, 4.0, 5.0 and 6.25 mL/kg bw. (corresponding to 2752, 3440, 4300, and 5375 mg/kg bw, respectively (based on a relative density of 0.86). Animals were then observed for mortality and signs of toxicity for 14 days as well as macroscopic lesions during necropsy.
1, 4, 6 and 8 deaths occurred at each tested dose level of 3.2, 4.0, 5.0 and 6.25 mL/kg bw, respectively. Slight ataxia and lethargy was observed during the study. The oral LD50 was calculated to be 3956 mg/kg bw (corresponding to 4.6 mL/kg bw) with 95% confidence limits of 3354 and 4558 mg/kg bw (corresponding to 3.9 and 5.3 mL/kg bw).
The oral LD50 for turpentine oil was found to be greater than 2000 mg/kg bw in the rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Alpha-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on alpha-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three mortalities were noted in animals treated at the dose of 2000 mg/kg body weight, at 24 hours post-dose.
No mortality was noted in the animals treated at the dose of 300 mg/kg body weight. - Clinical signs:
- other: At the dose of 2000 mg/kg the mortalities were preceded by a decrease in spontaneous activity (1/3) at 30 minutes post-dose. At the dose of 300 mg/kg no clinical signs related to the administration of the test item were observed during the study.
- Gross pathology:
- At the dose of 200 mg/kg the macroscopic examination of the animals revealed a thinning of the corpus (2/3).
At the dose of 300 mg/kg the macroscopic examination of the animals at the end of the study did not reveal treatment related changes. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of test item alpha-pinene multiconstituent is higher than 300 mg/kg body weight and lower than 2000 mg/kg by oral route in the rat.
In accordance with guideline OECD 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with Regulation EC No. 1272/2008, test item alpha-pinene multiconstituent has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful if swallowed” are required - Executive summary:
The test item alpha-pinene multiconstituent was administered to a group of 3 female Sprague Dawley rats at the dose of 2000 mg/kg body weight and then to a group of 6 female Sprague Dawley rats at the dose of 300 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation No. 440/2008.
Three mortalities were noted in animals treated at the dose of 2000 mg/kg body weight, at 24 hours post-dose.
The mortalities were preceded by a decrease in spontaneous activity (1/3) at 30 minutes post-dose. No other signs of systemic toxicity were noted.
Rigor mortis were noted before the necropsy in two animals (2/3). The macroscopic examination of the animals revealed a thinningof the corpus (2/3).
No mortality was noted in the animals treated at the dose of 300 mg/kg body weight.
No clinical signs related to the administration of the test item were observed during the study.
The body weight evolution of the animals remained normal throughout the study.
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
In conclusion, the LD50 of test item alpha-pinene multiconstituent is higher than 300 mg/kg body weight and lower than 2000 mg/kg by oral route in the rat.
In accordance with guideline OECD 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
Referenceopen allclose all
None
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed following the method similar to OECD guideline 403 with deviations: No information on housing conditions of animals, body weight of animals not recorded during the study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- 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 or test system 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
- Key result
- 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 - Interpretation of results:
- harmful
- Remarks:
- Migrated information Category 4 Criteria used for interpretation of results: EU
- 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 the method similar to OECD guideline 403, group 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:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1967
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed following the method similar to OECD guideline 403 with deviations: No information on housing conditions of animals; no data on exposure concentration and mortality, body weight and clinical signs of toxicity not reported; exposure duration 2 hours
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- no information on housing conditions of animals; no data on exposure concentration and mortality, body weight and clinical signs of toxicity not reported; exposure duration 2 hours
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 25-30 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: 29 mm * 12.5 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:
- 2 h
- Concentrations:
- Four concentration, no data on concentration used
- No. of animals per sex per dose:
- 10-19 animals per concentration
- Control animals:
- not specified
- Details on study design:
- No data
- Duration of observation period following administration: One week - Statistics:
- All LC50 calculations were done by the Litchfield-Wilcoxon (1949) method.
- Preliminary study:
- Not applicable
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 29 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 2 h
- Remarks on result:
- other: 25.6-32.8 mg/L
- Mortality:
- No data
- Clinical signs:
- other: Apnea
- Body weight:
- No data
- Gross pathology:
- Lesions noticed in lungs were similar in type and extent to those found among controls
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Inhalation LC50 for turpentine vapors was found to be 29 mg/L/2 hour in mice.
- Executive summary:
In an inhalation acute toxicity study performed following the method similar to OECD guideline 403, group of male Swiss-Webster mice (10-19/concentration) were exposed to four concentrations of turpentine vapors for 2 hours. Surviving animals were observed for one week for clinical signs of toxicity and 2-hour LC50 was determined by Litchfield-Wilcoxon method.
Apnea was observed in exposed animals. Lesions noticed in lungs were similar in type and extent to those found among controls. The 2-hour LC50 for turpentine vapors was calculated to be 29 mg/L.
Under the test conditions, the inhalation LC50 for turpentine vapors was found to be 29 mg/L in mice after 2-h exposure.
Referenceopen allclose all
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 |
None
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 13 700 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1972
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Test method and results not sufficiently detailed
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on 10 rabbits at one selected dose
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Abdominal skin
- Type of wrap if used: Wrapped with binder of rubber dam, gauze and adhesive tape
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: Observed for signs of erythema, edema and atonia - Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: see other findings for skinn irritation signs
- Gross pathology:
- No abnormalities found at necropsy
- Other findings:
- - Slight erythema in 8 animals on Day 1; 5 animals on Day 2; and 2 animals on Day 3 and 4
- Slight edema in 4 animals on Day 1; and 2 animals on Day 2 and 3
- Moderate erythema and edema in 1 animal on Day 1
- All animals recovered within 5 days - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of turpentine oil is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
Turpentine oil was tested for acute dermal toxicity in New Zealand White rabbit in a limit dose assay. 10 rabbit were administered a single dermal dose of turpentine oil at 2000 mg/kg bw on clipped skin using an occlusive patch for 24 hours. All animals were observed for mortality, body weights and dermal reactions for 7 days. Animals were killed at the end of the study and subjected to necropsy for macroscopical examination.
No deaths occurred throughout the study. At necropsy, macroscopic examination of main organs showed no abnormalities. Adverse dermal reactions noted were slight to moderate erythema and edema with complete reversal in 5 days. Normal body weight gain was observed in all animals. The acute dermal LD50 was greater than 2000 mg/kg bw.
The acute dermal LD50 of turpentine oil is greater than 2000 mg/kg bw in rabbits and therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Alpha-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on alpha-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema and dryness) were noted in all animals (10/10) at 24 h post-dose and were totally reversible on day 13.
- Gross pathology:
- No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of alpha-pinene multiconstituent is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) n° 1272/2008 and UN GHS.
- Executive summary:
In an acute dermal toxicity study performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) was given a single dermal application of alpha-pinene multiconstituent at 2000 mg/kg bw. The test item was applied on dorsal area of the trunk representing approximately 10% of the total body surface area of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema and dryness) were noted in all animals (10/10) at 24-hour post-dose and were totally reversible on day 13. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.
In conclusion, the LD50 of test item alpha-pinene multiconstituent is higher than 2000 mg/kg body weight by dermal route in the rat. Test item alpha-pinene multiconstituent does not have to be classified in accordance with Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures and UN GHS.
Referenceopen allclose all
None
None
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
One acute oral toxicity study was available for alpha-pinene, one main constituent of gum turpentine oil. It showed LD50 > 300 mg/kg bw but < 2000 mg/kg bw.
One acute dermal toxicity study was also available for alpha-pinene and turpentine oil and they showed LD50 >2000 mg/kg bw. These studies show consistent results about gum turpentine oil and one of its main constituent.
One acute inhalation study using turpentine oil vapors was available with two different periods of exposure: 2 h and 4 h. The acute inhalation LC50 found was 13700 mg/m3 after 4-h exposure and 29000 mg/m3 after 2-h exposure therefore turpentine is classified as “R20 Harmful by inhalation” according to Directive 67/548/EEC and in category 4 according to CLP Regulation (EC) n° 1272/2008.
Justification for classification or non-classification
Considering an oral LD50 of 500 mg/kg and according to the criteria of Regulation EC No. 1272/2008, alpha-pinene and gum turpentine oil have to be classified in category 4 for acute oral toxicity. The signal word “Warning” and hazard statement H302 “Harmful if swallowed” are required.
As LD50 for dermal acute toxicity is higher than 2000 mg/kg bw, the test item is not classified according to CLP Regulation (EC) n° 1272/2008.
The acute inhalation LC50 found was 13700 mg/m3 after 4-h exposure and 29000 mg/m3 after 2-h exposure therefore turpentine is classified as “R20 Harmful by inhalation” according to Directive 67/548/EEC and in category 4 according to CLP Regulation (EC) n° 1272/2008.
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