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EC number: 939-396-3 | 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
The oral LD50 for dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in female rats.
The acute dermal LD50 of dihydroterpineol multiconstituent is higher than 2000 mg/kg bw 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:
- key study
- Study period:
- 04-19 February 2014
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 13 September 2013
- 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: Elevage Janvier Labs, Le Genest-St Isle, France.
- Age at study initiation: 9 weeks
- Weight at study initiation: 207-223 g
- Fasting period before study: Food was removed on Day 1 and then redistributed 4 h after administration of the test item.
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stainless steel mesh lid.
- Diet: Foodstuff (SAFE, A04), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 13 changes/h
- Photoperiod: 12 h dark / 12 h light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.20 mL/kg bw
DOSE ADMINISTRATION:
- In the first and second step of the study, the test item was administered by gavage under a volume of 2.20 mL/kg bw (corresponding to 2000 mg/kg bw according to the density of 0.908) using a suitable syringe graduated fitted with an oesophageal metal canula. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/dose
- Control animals:
- other: Study no.: TAO-2014-001 (no treatment related changes were observed)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects at 30 minutes, 1, 3, 4, 24 and 48 h after administration of the item and continued during 14 days following the administration of test item. Clinical observations and mortality were recorded every day for 14 days.
Bodyweight: Animals were weighed on Days 0 (just before administering the test item), 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anesthetized with sodium pentobarbital and administration continued to fatal levels and macroscopic examination was performed. - Statistics:
- None
- Preliminary study:
- Not Applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was observed in one rat treated at 2000 mg/kg bw (1/6), 25 h and 35 minutes post-dose, during the second step of the study.
- Clinical signs:
- other: - Mortality was preceded by an absence or decrease in spontaneous activity, Preyer's reflex, body temperature, muscle tone and righting reflex, myosis, lacrymation, bradypnea and staggering gait were noted on Day 0. - In the surviving animals treated at 2
- Gross pathology:
- Macroscopic examination of dead animal revealed a thinning and a red coloration of the fore stomach.
No macroscopic abnormalities were observed in surviving animals. - Other findings:
- None
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- not classified according to the CLP Regulation (EC) N° 1272/2008
- Conclusions:
- The oral LD50 for dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in female rats. Therefore it is not classified according to the CLP Regulation (EC) N° 1272/2008.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of dihydroterpineol multiconstituent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
One animal was died at 2000 mg/kg bw. Mortality was preceded by an absence or decrease in spontaneous activity, Preyer's reflex, body temperature, muscle tone and righting reflex, myosis, lacrymation, bradypnea and staggering gait were noted on Day 0. Similar clinical signs were observed in the surviving animals from 30 minutes postdose and were totally reversible at 24 h post-dose. Body weight gain of the treated animals was not affected by test item. Macroscopic examination of dead animal revealed a thinning and a red coloration of the fore stomach. No macroscopic abnormalities were observed in surviving animals. In this study, the oral LD50 of test item was considered to be higher than 2000 mg/kg bw in female rats.
Therefore, the oral LD50 for the test item is higher than 2000 mg/kg bw in female rats therefore it is not classified according to CLP Regulation (EC) N° 1272/2008.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- 04-18 February 2014
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 13 September 2013
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Males: 8 weeks; Females: 9 weeks
- Weight at study initiation: Males: 288-336 g; Females: 198-248 g
- Housing: Animals were housed in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; During the treatment, the animals were kept in individual cages and after the removal of the patch on Day 1, the animals were put into their cage by group of 5.
- Diet: Foodstuff (SAFE, A04), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 13 changes/h
- Photoperiod: 12 h dark / 12 h light - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 h before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping.
TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: Approximately 10 % of the body surface area
- Type of wrap if used: Test material was applied by topical application, under porous gauze dressing.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Dose volume: 2.20 mL/kg bw (corresponding to 2000 mg/kg bw according to the density of 0.908)
- Constant volume or concentration used: Yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: Study no.: TAD-2014-001 (no treatment related changes were observed)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects on the major physiological functions at 1, 3 and 5 h post dose and thereafter every day for 14 days. Clinical observations and mortality were recorded every day for 14 days.
- The integrity of the skin on the application site was noted.
Bodyweight was recorded on Days 0 (just before administering test item), 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels and macroscopic examination was performed. - Statistics:
- None
- 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: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- 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 dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in rats. Therefore it is not classified according to GHS and CLP Regulation (EC) N° 1272/2008.
- Executive summary:
In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) were given a single dermal application of dihydroterpineol 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 was observed. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of the test item was considered to be higher than 2000 mg/kg bw in rats.
The acute dermal LD50 of dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) N° 1272/2008.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of dihydroterpineol multiconstituent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
One animal was died at 2000 mg/kg bw. Mortality was preceded by an absence or decrease in spontaneous activity, Preyer's reflex, body temperature, muscle tone and righting reflex, myosis, lacrymation, bradypnea and staggering gait were noted on Day 0. Similar clinical signs were observed in the surviving animals from 30 minutes postdose and were totally reversible at 24 h post-dose. Body weight gain of the treated animals was not affected by test item. Macroscopic examination of dead animal revealed a thinning and a red coloration of the fore stomach. No macroscopic abnormalities were observed in surviving animals. In this study, the oral LD50 of test item was considered to be higher than 2000 mg/kg bw in female rats.
Therefore, the oral LD50 for the test item is higher than 2000 mg/kg bw in female rats therefore it is not classified according to CLP Regulation (EC) N° 1272/2008.
In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) were given a single dermal application of dihydroterpineol 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 was observed. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of the test item was considered to be higher than 2000 mg/kg bw in rats.
The acute dermal LD50 of dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) N°1272/2008.
Justification for classification or non-classification
The oral LD50 for dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in female rats.
The acute dermal LD50 of dihydroterpineol multiconstituent is higher than 2000 mg/kg bw in rats.
Therefore it is not classified according to GHS and CLP Regulation (EC) N° 1272/2008.
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