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EC number: 905-474-0 | 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
Oral LD50 was higer than 2000 mg/kg in an OECD 423 study conducted in rats in compliance with GLP.
Dermal LD50 was higer than 2000 mg/kg in an OECD 402 study conducted in rats in compliance with GLP.
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:
- 17 May 2016 - 01 June 2016,
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: by Elevage JANVIER LABS (53940 Le Genest St Isle – France),
- Females nulliparous and non-pregnant:
- Age at study initiation: 8 weeks
- Weight at study initiation: from 182 to 207 g
- Housing: animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): from 19°C to 25°C
- Humidity (%): from 30% to 70%
- Air changes : at least ten changes per hour
- Photoperiod: twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals of the treated group received an effective dose of 2000 mg/kg body weight of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE.
In the first and the second step of the study, the test item was administered by gavage under a volume of 2.36 mL/kg body weight (corresponding to 2000 mg/kg according to the density of 0.846 g/mL supplied by the Sponsor) using a suitable graduated syringe fitted with an oesophageal metal canula - Doses:
- 2000 mg/kg corresponding to 2.36 mL/ kg bw
- No. of animals per sex per dose:
- 6 (3 per step)
- Control animals:
- other: historical data
- Details on study design:
- Clinical observations and mortality were recorded every day for 14 days
Animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations. - Statistics:
- none
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two mortalities were noted in the animals treated at the dose of 2000 mg/kg body weight, one at 48 hours post dose during the first step of the study and a one at 24 hours post dose during the second step of the study.
- Clinical signs:
- The mortalities were preceded by a decrease in spontaneous activity (2/2). No others clinical signs were noted. In the surviving animals (4/6), a decrease in spontaneous activity (4/4) was noted during the first hours of the test. The animals recovered a normal activity at 3-hour post dose. No others signs of systemic toxicity were noted.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of this animal at the end of the study did not reveal any treatment related changes.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with OECD Guideline No. 423, the LD50 cut-off of the test item may be considered as 2500 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 REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified.
According to GHS regulation, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA- TERPINENES, TERPINOLENE is classified in category 5. Hazard statement H303 (may be harmful if swallowed) and signal word Attention are required. - Executive summary:
REACTION MASS OF DL-LIMONENE, ALPHA-GAMMA-TERPINENES, TERPINOLENE was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in OECD Guideline No. 423 dated December 17th, 2001 and test method B.1tris of Council regulation No. 440/2008.
Two mortalities were noted in the animals treated at the dose of 2000 mg/kg body weight, one at 48 hours post dose during the first step of the study and one at 24 hours post dose during the second step of the study. The mortalities were preceded by a decrease in spontaneous activity (2/2). No other clinical signs were noted. Rigor mortis was noted before the necropsy (2/2).The macroscopic examination of the animals revealed a thinning of forestomach and corpus with red spots (1/2).
In the surviving animals (4/6), a decrease in spontaneous activity (4/4) was noted during the first hours of the test. The animals recovered a normal activity at a 3-hour post dose. No others signs of systemic toxicity were noted. The macroscopic examination of this animal at the end of the study did not reveal any treatment related changes.
In conclusion, the LD50 of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with OECD Guideline No. 423, the LD50 cut-off of the test item may be considered as 2500 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 REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified.
No signal word or hazard statement is required.
According to GHS regulation, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA- TERPINENES, TERPINOLENE is classified in category 5. Hazard statement H303 (may be harmful if swallowed) and signal word Attention are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD 423 study without deviation, according to Good laboratory practice
Acute toxicity: via inhalation route
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:
- 17 May 2016 - 31 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle – France),
- Females nulliparous and non-pregnant
- Age at study initiation: 7 weeks old (male) and 8 weeks old (female)
- Weight at study initiation: for male from 260 to 280 g, and for female from 204 to 221 g
- Housing: individually in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet ad libitum (SAFE - A04)
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10 at least
- Photoperiod (hrs dark / hrs light): 12 hours light (07.00 to 19.00)
- Type of coverage:
- other: non occlusive porous gauze dressing
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Animals received by topical application, under non occlusive porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M), an effective dose of 2000 mg/kg body weight administered under a volume of 2.36 mL/kg body weight (according to the calculated density), during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated areas were rinsed with distilled water.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg equivalent to 2.36 mL/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical control
- Details on study design:
- Systematic examinations are carried out to identify any behavioral or toxic effects on the major physiological functions 1 hour, 3 hours, 5 hours, 24 hours and 48 hours after administration of the test item and continued on the following days if necessary.
This examination focusses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet.
These observations are compared to control data.
The integrity of the skin on the application site is noted.
Observations and a mortality report willare then be carried out every day for 14 days. The time of death is recorded individually in days and hours (if possible).
Weight changes in animals from treated group will beare compared to those of control animals.
Necropsies are carried out on animals that died during the test. Macroscopic observations are recorded on individual autopsy sheets. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No systemic clinical signs related to the administration of the test item were observed.
Erythema was noted in all animals at 24-hour post-dose and was totally reversible on day 11. Dryness of the skin and scab were noted between days 6 and 10. - Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE is higher than 2000 mg/kg body weight by dermal route in the rat.
Test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified in accordance with Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required. - Executive summary:
REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis ohe official method as defined in OECD Guideline No. 402 dated February 24th, 1987 and test method B.3 of Council regulation No. 440/2008 of 30 May 2008.
No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Erythema was noted in all animals at 24-hour post-dose and was totally reversible on day 11. Dryness of the skin and scab were noted between days 6 and 10. 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 REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENEis higher than 2000 mg/kg body weight by dermal route in the rat.
Test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified in accordance with Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD 402 study without deviation, according to Good laboratory practice
Additional information
Justification for classification or non-classification
The LD50 of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with OECD Guideline No. 423, the LD50 cut-off of the test item may be considered as 2500 mg/kg body weight by oral route in the rat.
Therefore, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with Regulation EC No. 1272/2008, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified.
According to GHS regulation, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA- TERPINENES, TERPINOLENE is classified in category 5. Hazard statement H303 (may be harmful if swallowed) and signal word Attention are required.
The LD50 of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE is higher than 2000 mg/kg body weight by dermal route in the rat.
Therefore, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with Regulation EC No. 1272/2008, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not have to be classified.
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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