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EC number: 945-713-6 | CAS number: -
- 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
Acute oral toxicity: Key study. Test method in accordance with OECD Test Guideline 423, following GLP. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 5000 mg/kg body weight by oral route in the rat.
Acute oral toxicity: Supporting studies. Based on the experimental results obtained with the analogue substance camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw. Also, based on the experimental results obtained with the analogue substance alpha pinene, the acute oral LD50 of the reaction mass in rats is expected to be 3.7 g/kg bw (2.3 -5.1 g/kg bw).
Acute inhalation toxicity: Supporting studies. Based on the experimental results obtained with the analogue substance camphene, the acute inhalation LC0 of the reaction mass is expected to be equal or greater than 243 mg/kg. Also, based on the experimental results obtained with the analogue substance alpha pinene, the LC50 of the reaction mass (for the shortest period causing death) is predicted to be 625 mg/l/min in rats.
Acute dermal toxicity: Weight of evidence. Based on the experimental results obtained with the analogue substance camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw. Also, based on the experimental results obtained with the analogue substance alpha pinene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 5 g/kg bw.
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- Remarks on result:
- other: confidence limit: 2300-5100 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value in rats was reported as 3.7 g/kg bw (2.3 -5.1 g/kg bw)
- Executive summary:
The acute oral LD50 value in rats was reported as 3.7 g/kg bw (2.3 -5.1 g/kg bw)
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
- Executive summary:
The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
- Executive summary:
The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance alpha pinene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 = 3700 mg/kg bw (confidence limit: 2300-5100 mg/kg bw)
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue alpha pinene, the acute oral LD50 of the reaction mass in rats is expected to be 3.7 g/kg bw (2.3 -5.1 g/kg bw)
- Executive summary:
Based on read across from the analogue alpha pinene, the acute oral LD50 of the reaction mass in rats is expected to be 3.7 g/kg bw (2.3 -5.1 g/kg bw)
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 5000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw.
- Executive summary:
Based on read across from the analogue camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw.
- 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:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 5000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw.
- Executive summary:
Based on read across from the analogue camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 2017 - 10 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: 173.8 to 201.8 g
- Fasting period before study: overnight prior to dosing until three hours post-dosing
- Housing: 3 females in polypropylene rat cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material. Wooden blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Ad libitum. Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA. The quality of feed is regularly monitored at Jai Research Foundation.
- Water (e.g. ad libitum): Ad libitum. UV sterilized water filtered through Reverse Osmosis water filtration system. The quality of water is regularly monitored at Jai Research Foundation.
- Acclimation period: 6 to 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 57 to 67%
- Air changes (per hr): At least 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours contimuous light (06.00 to 18.00 h) and 12 hours darkness.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.4 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: without preliminary information, the selected starting dose is 300 mg/kg body weight. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxicity and mortality at 30 min, 1h, 2 h, 3h, 4h, 6 h after adminitration. Morbidity and mortality twice a day and clinical sings daily during 14 days. Weighing= D0 (prior to dosing) then on D7, and D14.
- Necropsy of survivors performed: yes. At termination, macroscopic observation was observed.
- Other examinations performed:
Clinical observations: evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects and central nervous system effects, behavioural pattern, somatomotor activity and observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No clinical sign was observed in rats treated with 300 and 2000 mg/kg body weight.
- Body weight:
- Normal gain in body weight was observed in all the rats treated with 300 and 2000 mg/kg body weight.
- Gross pathology:
- External and visceral examination of terminally sacrificed rats did not reveal any abnormality.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 5000 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 12 female Wistar rats divided in 4 groups were administered sequentially with test item by oral gavage. The first set of 3 female rats was given a single dose of 300 mg/kg body weight. No mortality was observed at this dose level, so the second set of 3 female rats was treated at the same dose level. No mortality was observed at this dose level, so the third set of 3 female rats was treated at the higher dose level of 2000 mg/kg bw. As no mortality was observed at this dose level, the fourth set of 3 female rats was treated at the same dose level of 2000 mg/kg bw. The body weight evolution of the animals remained normal during the study. No clinical signs were observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be 5000 mg/kg body weight by oral route in the rat.
Referenceopen allclose all
The acute oral LD50 value in rats was reported as 3.7 g/kg bw (2.3 -5.1 g/kg bw)
The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
The acute oral LD50 value in rats was reported as greater than 5 g/kg bw.
Table 1: Mortality
Dose (mg/kg body weight) |
Set N° |
Number of Rats Used |
Mortality after Dosing |
||||||
At Hour |
On Day |
||||||||
0.5 - 4 |
6 |
1 |
2 |
3 |
4 - 7 |
8 - 14 |
|||
300 |
I |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2000 |
III |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IV |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Individual and Mean Body Weight (g) and Body WeightChange (%)
Dose (mg/kg body weight) |
Rat N° |
Volume of Dose Administered (mL) |
Body Weight (g) on Day |
Percent Body Weight Change on Day |
|||
|
|
|
0 |
7 |
14 |
7 |
14 |
300 |
1 |
0.06 |
186.8 |
209.6 |
225.3 |
12.2 |
20.6 |
|
2 |
0.07 |
188.1 |
219.8 |
230.8 |
16.9 |
22.7 |
|
3 |
0.06 |
183.4 |
204.5 |
218.4 |
11.5 |
19.1 |
|
Mean |
|
186.1 |
211.3 |
224.8 |
13.5 |
20.8 |
|
Standard Deviation (±) |
|
2.4 |
7.8 |
6.2 |
2.9 |
1.8 |
|
4 |
0.07 |
191.1 |
216.6 |
224.8 |
13.3 |
17.6 |
|
5 |
0.07 |
201.1 |
236.8 |
247.9 |
17.8 |
23.3 |
|
6 |
0.06 |
186.7 |
214.2 |
227.4 |
14.7 |
21.8 |
|
Mean |
|
193.0 |
222.5 |
233.4 |
15.3 |
20.9 |
|
Standard Deviation (±) |
|
7.4 |
12.4 |
12.7 |
2.3 |
3.0 |
2000 |
7 |
0.47 |
201.8 |
212.8 |
228.8 |
5.5 |
13.4 |
|
8 |
0.43 |
187.3 |
204.5 |
223.6 |
9.2 |
19.4 |
|
9 |
0.43 |
184.5 |
203.8 |
218.5 |
10.5 |
18.4 |
|
Mean |
|
191.2 |
207.0 |
223.6 |
8.4 |
17.1 |
|
Standard Deviation (±) |
|
9.3 |
5.0 |
5.2 |
2.6 |
3.2 |
|
10 |
0.41 |
176.0 |
190.4 |
205.6 |
8.2 |
16.8 |
|
11 |
0.40 |
173.8 |
188.8 |
193.8 |
8.6 |
11.5 |
|
12 |
0.42 |
182.4 |
199.0 |
201.5 |
9.1 |
10.5 |
|
Mean |
|
177.4 |
192.7 |
200.3 |
8.6 |
12.9 |
|
Standard Deviation (±) |
|
4.5 |
5.5 |
6.0 |
0.5 |
3.4 |
Key: Day 0 = Before dosing
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Test method was not according to any guideline. The species used was the rabbit. However, the recommended species for the acute inhalation toxicity is the rat. No GLP.
- Principles of method if other than guideline:
- - Principle of test: Studies on the pharmacological expectorant activity of nutmeg oil and camphene given by inhalation to rabbits arranged for the collection of respiratory tract fluid.
- Short description of test conditions: see below
- Parameters analysed / observed: volumen of respiratory tract fluid, expectorant activity and odor - GLP compliance:
- no
- Test type:
- other: Study of the pharmacological expectorant activity of test substance
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young
- Weight at study initiation: 2-3 kg
- Housing: They were housed in boarding cages, one animal per cage.
- Diet (e.g. ad libitum): They were fed a standard rabbit ration of mixed natural foods, salts, and vitamins. - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
In preparation for the collection of respiratory tract fluid, the rabbits were anesthetized with urethane (ethyl carbamate) given by intraperitoneal injection in a dose of 4.0 to 5.0 mL/kg body weight of a 25% (w/v) solution in distilled water. This produced a light anesthesia lasting over 24 hours with no reported effect on the volume and composition of respiratory tract fluid except that it augmented the concentration of potassium ion.
One arm of a T-shaped cannula was ligated into the trachea, a collecting tube attached to the second arm, and the third arm was connected with a reservoir of conditioned air maintained at 39 ºC and saturated with water vapor. The conditioned air was prepared by mixing laboratory air with steam from a thermostatically controlled water vaporizer. Steam generated by this vaporizer volatilized the test item which was carried to the conditioned air reservoir from which it was inhaled by each anesthetized rabbit.
Respiratory tract fluid was collected for a control period of two to four hours. The collecting tube was then replaced by a cleaned, empty tube, test item added to the vaporizer, and respiratory tract fluid collected for a subsequent period of four to six hours. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- >= 4 - <= 6 h
- Concentrations:
- 1, 3, 9, 27, 81, and 243 mg/kg
- No. of animals per sex per dose:
- 4-6 male rabbits per dose
- Control animals:
- other: The controls were the same animals, before being treated.
- Details on study design:
- - Duration of observation period following administration: 24 hours, which is a standard method of expressing the volume output of respiratory tract fluid.
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- >= 243 other: mg/kg
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: Inhalation of camphene by urethanized rabbits in doses 3-27 mg/kg produced significant increase in volume output of respiratory tract fluid, accompanied by decrease in specific gravity and increase in total solids. Dose-dependent increase in volume output
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The LC 0 was equal or greater than 243 mg/kg.
- Executive summary:
Camphene was given by inhalation to male rabbits that were anesthetized with urethane (ethyl carbamate) for 24 hours and were arranged for collection of respiratory tract fluid. Test substance was dissolved in 1 mL of ethanol in amounts of 1, 3, 9, 27, 81, and 243 mg. Each dose was given to 4 to 6 rabbits. Respiratory tract fluid was collected for a control period of two to four hours. The collecting tube was then replaced by a cleaned, empty tube, test item added to the vaporizer, and respiratory tract fluid collected for a subsequent period of four to six hours. Steam generated by the water vaporizer volatilized the test item which was carried to the conditioned air reservoir from which it was inhaled by each anesthetized rabbit. Inhalation of camphene by urethanized rabbits in doses 3-27 mg/kg produced significant increase in volume output of respiratory tract fluid, accompanied by decrease in specific gravity and increase in total solids. Dose-dependent increase in volume output of respiratory tract fluid varied with the season. The expectorant action began to disappear following inhalation of a dose of 81 mg/kg, which is well below the level detectable by odour (243 mg/kg) and far below the probably fatal dose. Based on these results, the LC0 was established to be equal or greater than 243 mg/kg.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Test animals inhaled saturated vapours of alpha pinene from steam distillation of wood. - Analytical verification of test atmosphere concentrations:
- not specified
- Concentrations:
- 26 mg/L
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 625 other: mg/L/min
- Based on:
- test mat.
- Remarks on result:
- other: Effect level is the LC for the shortest period causing death
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The LC50 of the test item (for the shortest period causing death) is 625 mg/l/min in rats.
- Executive summary:
Alpha pinene was given to rats through inhalation of saturated vapours (26 mg/L of alpha pinene) obtained from steam distillation of wood. The LC50 of the test item (for the shortest period causing death) was found to be 625 mg/l/min.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- >= 243 other: mg/kg
- Based on:
- other: Read-across from an analogue
- Exp. duration:
- 6 h
- Remarks on result:
- other: read-across from an analogue for which LC0 >= 243 mg/kg
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on read across from the analogue camphene, the LC0 of the reaction mass is expected to be equal or greater than 243 mg/kg.
- Executive summary:
Camphene was given by inhalation to male rabbits that were anesthetized with urethane (ethyl carbamate) for 24 hours and were arranged for collection of respiratory tract fluid. Test substance was dissolved in 1 mL of ethanol in amounts of 1, 3, 9, 27, 81, and 243 mg. Each dose was given to 4 to 6 rabbits. Respiratory tract fluid was collected for a control period of two to four hours. The collecting tube was then replaced by a cleaned, empty tube, test item added to the vaporizer, and respiratory tract fluid collected for a subsequent period of four to six hours. Steam generated by the water vaporizer volatilized the test item which was carried to the conditioned air reservoir from which it was inhaled by each anesthetized rabbit. Inhalation of camphene by urethanized rabbits in doses 3-27 mg/kg produced significant increase in volume output of respiratory tract fluid, accompanied by decrease in specific gravity and increase in total solids. Dose-dependent increase in volume output of respiratory tract fluid varied with the season. The expectorant action began to disappear following inhalation of a dose of 81 mg/kg, which is well below the level detectable by odour (243 mg/kg) and far below the probably fatal dose. Based on these results, the read-across approach was applied and the LC0 of the reaction mass is expected to be equal or greater than 243 mg/kg.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance alpha pinene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 625 other: mg/L/min
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LC50 = 625 mg/L/min (Effect level is the LC for the shortest period causing death)
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on read across from the analogue alpha pinene, the LC50 of the mass reaction (for the shortest period causing death) is predicted to be 625 mg/l/min in rats.
- Executive summary:
Alpha pinene was given to rats through inhalation of saturated vapours (26 mg/L of alpha pinene) obtained from steam distillation of wood. The LC50 of the test item (for the shortest period causing death) was found to be 625 mg/l/min. Based on these results, the read-across approach was applied and the LC50 for the reaction mass is expected to be 625 mg/l/min.
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
Referenceopen allclose all
The LC 0 was equal or greater than 243 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Supporting studies with Klimisch scores = 3 and 4. An appropriate dose descriptor could not be deduced from these study reports.
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value in rabbits was reported as greater than 5 g/kg bw.
- Executive summary:
The acute dermal LD50 value in rabbits was reported as greater than 5 g/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
- Executive summary:
The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
- Executive summary:
The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance alpha pinene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 5000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue alpha pinene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 5 g/kg bw.
- Executive summary:
Based on read across from the analogue alpha pinene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 5 g/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 2500 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw.
- Executive summary:
Based on read across from the analogue camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 2500 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on read across from the analogue camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw.
- Executive summary:
Based on read across from the analogue camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw.
Referenceopen allclose all
The acute dermal LD50 value in rabbits was reported as greater than 5 g/kg bw.
The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
The acute dermal LD50 value in rabbits was reported as greater than 2.5 g/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Weight of evidence from several studies with Klimisch score = 4
Additional information
Acute oral toxicity: Key study: The acute oral toxicity of the test item has been tested in accordance with OECD Test Guideline 423, following GLP. 12 female Wistar rats divided in 4 groups were administered sequentially with test item by oral gavage.The first set of 3 female rats was given a single dose of 300 mg/kg body weight. No mortality was observed at this dose level, so the second set of 3 female rats was treated at the same dose level. No mortality was observed at this dose level, so the third set of 3 female rats was treated at the higher dose level of 2000 mg/kg bw. As no mortality was observed at this dose level, the fourth set of 3 female rats was treated at the same dose level of 2000 mg/kg bw. The body weight evolution of the animals remained normal during the study.No clinical signs were observed.The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be 5000 mg/kg body weight by oral route in the rat.
Acute oral toxicity: Supporting studies. Based on the experimental results obtained with the analogue substance camphene, the acute oral LD50 of the reaction mass in rats is expected to be greater than 5 g/kg bw.. Also, based on the experimental results obtained with the analogue substance alpha pinene, the acute oral LD50 of the reaction mass in rats is expected to be 3.7 g/kg bw (2.3 -5.1 g/kg bw).
Acute inhalation toxicity: Supporting study. Camphene was given by inhalation to male rabbits that were anesthetized with urethane (ethyl carbamate) for 24 hours and were arranged for collection of respiratory tract fluid. Test substance was dissolved in 1 mL of ethanol in amounts of 1, 3, 9, 27, 81, and 243 mg. Each dose was given to 4 to 6 rabbits. Respiratory tract fluid was collected for a control period of two to four hours. The collecting tube was then replaced by a cleaned, empty tube, test item added to the vaporizer, and respiratory tract fluid collected for a subsequent period of four to six hours. Steam generated by the water vaporizer volatilized the test item which was carried to the conditioned air reservoir from which it was inhaled by each anesthetized rabbit. Inhalation of camphene by urethanized rabbits in doses 3-27 mg/kg produced significant increase in volume output of respiratory tract fluid, accompanied by decrease in specific gravity and increase in total solids. Dose-dependent increase in volume output of respiratory tract fluid varied with the season. The expectorant action began to disappear following inhalation of a dose of 81 mg/kg, which is well below the level detectable by odour (243 mg/kg) and far below the probably fatal dose. Based on these results, the read-across approach was applied and the LC0 of the reaction mass is expected to be equal or greater than 243 mg/kg.
Acute inhalation toxicity: Supporting study. Alpha pinene was given to rats through inhalation of saturated vapours (26 mg/L of alpha pinene) obtained from steam distillation of wood. The LC50 of the test item (for the shortest period causing death) was found to be 625 mg/l/min. Based on these results, the read-across approach was applied and the LC50 for the reaction mass is expected to be 625 mg/l/min.
Acute dermal toxicity: Weight of evidence. Based on the experimental results obtained with the analogue substance camphene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 2.5 g/kg bw. Also, based on the experimental results obtained with the analogue substance alpha pinene, the acute dermal LD50 of the reaction mass in rabbits is expected to be greater than 5 g/kg bw.
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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