Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-780-7 | 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
Pharmakon Research International, Inc. (1982) investigated the acute oral toxicity potential of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers on female and male Sprague-Dawley rat. A single dose of 5 mg/kg was administered orally by gavage and animals were observed for 14 days. The results showed no mortality during the study and no visible lesions were recorded at necropsy. Piloerection and diarrhea were observed in 7 rats after dosing. After 2 days diarrhea and piloerection, and decreased body were observed in 2 different rats, while after 3 days decreased body tone was observed in 1 rat.
In conclusion, the acute oral toxicity in rats was determined to be greater than 5000 mg/kg.
A second study used only as supporting study, was performed to determine the acute oral toxicity profile of test material Terpenes and Terpenoids, turpentine-oil, beta pinene fraction, polymd. The study performed at Chemical Hygiene Fellowship (CHF) in 1977 did not follow any guideline and the GLP conditions are not specified.
Ten male Hilltop-Wistar albino rats were exposed to 10 and 5 g/Kg of the test material in one unique dose. No signs of toxicity were recorded and no deaths occurred.
According to the results of this study, the LD50 acute oral of the test material Terpenes and Terpenoids, turpentine-oil, beta pinene fraction, polymd LD50 was >10 g/Kg.
Data on acute dermal toxicity are available on Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers (Pharmakon Research International Inc.,1982) and on
Terpenes and Terpenoids, turpentine-oil, beta pinene fraction, polymd (Chemical Hygiene Fellowship (CHF), 1977).
In the first key study, the test material was tested on 10 male and female rabbits. Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was applied to about 240 cm of the dorsal body surface skin, which was previously shaved. The application was done directly onto the exposed skin of the animals and a layer of gauze was wrapped around the animals to cover the dosed area. In addition, the animals were wrapped with a rubber dam to retard evaporation. The skin was exposed for 24 hrs and the animals were observed for 14 days. The results of the test showed that the acute dermal LD50 was greater than 2000 mg/kg.
The second supporting study was performed to determine the acute dermal toxicity profile of test material Terpenes and Terpenoids, turpentine-oil, beta pinene fraction, polymd. The study, performed at Chemical Hygiene Fellowship (CHF) did not follow any guideline and the GLP conditions are not specified.
Five male Albino rabbit were exposed to 10 g/Kg of the test material. The material was applied to clipped, unbraded skin. It was dosed under polyethylene sheeting.
No signs of toxicity were recorded and no deaths occurred. The gross autopsy showed pale kidney, but no details are available.
According to the results of this study, the LD50 acute dermal of the test material Terpenes and Terpenoids, turpentine-oil, beta pinene fraction, polymd LD50 was >10 g/Kg.
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:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Limit test at 1 dose level
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Test material: Zonares A25
Batch Number: AIA804
Date of receipt: 15 January 2018
Handling Instructions: Standard precautions - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Age at study initiation: Not reported
- Weight at study initiation: Male: 225-275 grams (before fasting)
- Fasting period before study: 18 hrs
- Housing: Individual stainless steel1/2 wire mesh cages.
- Sanitization: Waste material was removed daily. Cages and feeders were sanitized every two weeks
- Diet (e.g. ad libitum): Purina Certified Rodent Meal #5002, ad libitum, checked daily.
- Food analysis: No contaminants were detected.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using an automatic watering system supplied by Edstrom Industries Inc.
- Water analysis: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12 hrs dark - Route of administration:
- oral: gavage
- Details on oral exposure:
- VEHICLE
- Information not reported
MAXIMUM DOSE VOLUME APPLIED:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Potential route for human exposure - Doses:
- Dose administration: 5000 mg/kg
Volume administration: 5 ml/kg - No. of animals per sex per dose:
- 5 females and 5 males
- Details on study design:
- - Frequency and duration administration: Once
- Length of the study: 15 days
- Frequency of observations and weighing: Weight and death body weights were recorded on Days -1, 1, 2, 3, 4, 7, 11.
- Necropsy of survivors performed: yes
- Other examinations performed: Twice daily rats were observed for clinical effects, CNS effects and mortality. - Statistics:
- Not reported
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study
- Clinical signs:
- 5 hrs after dosing: piloerection was observed in 7/10 rats
At Day 2: Diarrhea and piloerection, and decreased body were observed in 2 different rats.
At Day 3: Decreased body tone was observed in 1 rat. - Body weight:
- No significant changes
- Gross pathology:
- No visible lesions
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- The estimated acute oral LD50 in rats for Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was determined to be greater than 5000 mg/kg.
- Executive summary:
The study investigated the Acute oral toxicity of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers on female and male Sprague-Dawley rat. A single dose of 5000 mg/kg was administered orally by gavage and animals were observed for 14 days. No mortality occurred during the study and no visible lesions were recorded at necroscopic analysis. Piloerection and diarrhea were observed in 7 rats after dosing. After 2 days diarrhea and piloerection, and decreased body were observed in 2 different rats, while after 3 days decreased body tone was observed in 1 rat.
In conclusion, the acute oral toxicity in rats was determined to be greater than 5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc.
- Weight at study initiation: 2-3 kg
- Fasting period before study:
- Housing: Separate isolation by test system
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed.
- Food Analysis: Acute dose minimize the effect of contaminants. There were no contaminants.
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc.
- Water Analyses: Conducted by Pennsylvania Gas and Water Company
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light-12 hrs dark - Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk of animal, dorsal body surface area
- % coverage: 100%
- Type of wrap if used: Layer of gauze, rubber dam and an ace bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was wiped to remove any remaining material
- Time after start of exposure: After 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mg/kg
- Concentration (if solution):
- Constant volume or concentration used: yes
VEHICLE
- Information not reported - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females and 5 males
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: Observation were recorderd at 10-20 minutes, 1-2 and 4-6 hrs after the 24 hrs period of exposure, and twice daily thereafter for fourteen days.
- Frequency of observations and weighing: Body weights were recorderd on Days: -1, 1, 2, 3, 4, 7, 11, 15.
- Gross necropsy of survivors performed: yes
- Other examinations performed: treated and untreated skin was preserved in 10% buffered formalin and retained for possible histopathological examinations. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 other: mg/kg
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- Decreased body tone
- Body weight:
- No changes
- Gross pathology:
- No visible lesions
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- Based on the observations made in the acute dermal toxicity Test in Rabbit, the estimated acute Dermal LD50 for Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers was determined to be greater than 2000 mg/kg.
- Executive summary:
The study investigated the acute dermal toxicity of Terpenes and terpenoids, turpentine oil, alpha-pinene fraction oligomers in 10 male and female rabbits. The test material was applied to about 240 cm of the dorsal body surface skin, which was previously shaved. The application was done direclty onto the exposed skin of the animals and a layer of gauze was wrapped around the animals to cover the dosed area. In addition, the animals were wrapped with rubber dam and an ace bandage to retard evaporation. The skin was exposed for 24 hrs and the animals were observed for 14 days. The results of the test showed that the acute dermal LD50 was greater than 2000 mg/kg.
Reference
Erythema Score | ||||||
Rabbit # | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Day 14 |
1 | 2 | 1 | 1 | 1 | 0 | 0 |
2 | 2 | 2 | 2 | 2 | 1 | 0 |
3 | 1 | 0 | 0 | 0 | 2 | 0 |
4 | 1 | 1 | 1 | 1 | 1 | 0 |
5 | 2 | 1 | 1 | 1 | 1 | 0 |
6 | 1 | 1 | 1 | 1 | 0 | 0 |
7 | 2 | 1 | 0 | 0 | 1 | 0 |
8 | 1 | 2 | 2 | 2 | 0 | 0 |
9 | 1 | 1 | 2 | 1 | 1 | 0 |
10 | 2 | 2 | 1 | 1 | 1 | 0 |
Edema score | ||||||
Rabbit # | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Day 14 |
1 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 1 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 1 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 1 | 0 | 0 | 0 | 0 | 0 |
8 | 0 | 0 | 0 | 0 | 0 | 0 |
9 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | 0 | 1 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 orUN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.