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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
Acute Toxicity: dermal
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-p-mentha-1,8-diene
- EC Number:
- 227-813-5
- EC Name:
- (R)-p-mentha-1,8-diene
- Cas Number:
- 5989-27-5
- Molecular formula:
- C10H16
- IUPAC Name:
- (4R)-isopropenyl-1-methylcyclohexene
- Reference substance name:
- (S)-p-mentha-1,8-diene
- EC Number:
- 227-815-6
- EC Name:
- (S)-p-mentha-1,8-diene
- Cas Number:
- 5989-54-8
- Molecular formula:
- C10H16
- IUPAC Name:
- (4S)-isopropenyl-1-methylcyclohexene
- Reference substance name:
- p-mentha-1,3-diene
- EC Number:
- 202-795-1
- EC Name:
- p-mentha-1,3-diene
- Cas Number:
- 99-86-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexa-1,3-diene
- Reference substance name:
- p-mentha-1,4(8)-diene
- EC Number:
- 209-578-0
- EC Name:
- p-mentha-1,4(8)-diene
- Cas Number:
- 586-62-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexene
- Reference substance name:
- p-mentha-1,4-diene
- EC Number:
- 202-794-6
- EC Name:
- p-mentha-1,4-diene
- Cas Number:
- 99-85-4
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexa-1,4-diene
- Reference substance name:
- (3R)-isopropylidene-6-methylcyclohexene
- Cas Number:
- 43124-56-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (3R)-isopropylidene-6-methylcyclohexene
- Reference substance name:
- (3S)-isopropylidene-6-methylcyclohexene
- Cas Number:
- 62504-16-9
- Molecular formula:
- C10H16
- IUPAC Name:
- (3S)-isopropylidene-6-methylcyclohexene
- Reference substance name:
- p-cymene
- EC Number:
- 202-796-7
- EC Name:
- p-cymene
- Cas Number:
- 99-87-6
- Molecular formula:
- C10H14
- IUPAC Name:
- 1-isopropyl-4-methylbenzene
- Reference substance name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-336-2
- EC Name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-03-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,4S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-337-8
- EC Name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-04-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,4R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (5S)-isopropyl-2-methylcyclohexa-1,3-diene
- Cas Number:
- 2243-33-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (5S)-isopropyl-2-methylcyclohexa-1,3-diene
- Reference substance name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- EC Number:
- 224-167-6
- EC Name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- Cas Number:
- 4221-98-1
- Molecular formula:
- C10H16
- IUPAC Name:
- (5R)-isopropyl-2-methylcyclohexa-1,3-diene
- Test material form:
- liquid
- Details on test material:
- Batch No.: 173391
Purity: 85.8% (sum of the five main constituents)
Name of test material (as cited in study report): Reaction mass of dl-limonene, alpha- gamma-terpinenes, terpinolene
Physical state: colourless - slightly yellow liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 1 October 2016
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
Test animals
- 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)
Administration / exposure
- 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.
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- 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.
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