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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-620-0 | CAS number: 14576-08-0
- 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
Skin corrosion: Not corrosive based on absence of eye irritation in rabbit eye and absence of irritant effects at 100% application in guinea pig (skin sensitisation).
Skin
irritation: Skin irritant (OECD TG 439): Irritant
Eye irritation (OECD TG 405): Not irritating
Respiratory irritation (based on absence of human data indicating such
effects, absence of effects in long-term inhalation study and absence of
skin corrosion and severy eye irritation): Not a respiratory irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 April, 2015 - 22 May, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModelTM
- Supplier : SkinEthic Laboratories, Lyon, France
- EpiSkinTM Tissues (0.38cm2) lot number: 15-EKIN-020 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test material
- Applied volume: 25 μL into 12-well plates on top of the skin tissues - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean compared to the negative control
- Value:
- 7.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Orange Flower Ether compared to the negative control tissues was 7.2%. Since the mean relative tissue viability for Orange Flower Ether was below 50% it is considered to be irritant.
- Interpretation of results:
- other: Criteria for Cat 2 are met
- Remarks:
- in accordance with EU CLP (1272/2008 and its updates)
- Conclusions:
- The relative mean tissue viability after 15 minutes treatment with Orange Flower Ether compared to the negative control tissue was 7.2%. Since the mean relative tissue viability for the substance was below 50% after 15 minutes treatment, the substance is considered to be irritant. The substance needs to be classified as Cat 2 and Cat 2A for EU CLP and GHS, respectively.
- Executive summary:
- The skin irritation potential of the test substance was tested through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 25 µL undiluted test substance. After 42 hours incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The positive control had a mean cell viability of 24% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 5%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 minutes treatment with the substance compared to the negative control tissue was 7.2%. Since the mean relative tissue viability for the test substance was below 50% after 15 minutes treatment the substance is considered to be irritant. Based on these results the substance needs to be classified as Cat 2 and Cat 2A for EU CLP and GHS, respectively.
Reference
Direct MTT Reduction
Orange Flower Ether was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test substance to MTT medium. Because no colour changes were observed it was concluded that Orange Flower Ether did not interact with the MTT endpoint.
Test Item, Positive Control Item and Negative Control Item
The relative mean viability of the test item treated tissues was 7.2 % after a 15 -minute exposure period and 42 hours post-exposure incubation period.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 24% relative to the negative control treated tissues.The positive control acceptance criterion was therefore satisfied.
The mean OD570 for the negative control treated tissues was 0.957 and the standard deviation was 0.023. The negative control acceptance criterion was therefore satisfied. The standard deviation value of the percentage viability of three tissues treated identically was less than 5%, indicating that the test system functioned properly.
Mean OD570 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD570 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD570 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
Negative Control Item |
0.983 |
0.957 |
0.023 |
100 |
|
0.946 |
|||||
0.940 |
|||||
Positive Control Item |
0.271 |
0.226 |
0.057 |
28 |
24 |
0.245 |
26 |
||||
0.162 |
17 |
||||
Test Item |
0.060 |
0.069 |
0.010 |
6.1 |
7.2 |
0.066 |
7.0 |
||||
0.080 |
8.5 |
SD = Standard deviation
*The mean viability of the negative control tissues is set at 100 %
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- See justification of information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 1980 - 27 February 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- An in vitro eye irritation was not conducted because information from an OECD TG 405 was availabel carried out before 2016.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 – 3.5 kg
- Housing: singly under standard laboratory conditions (as specified in “guide for the care and use of laboratory animals” DHEW Publication No. 78-23, Revised 1978). The suspended pans beneath the cage were littered with prepared bedding (Easi Litter)
- Diet: 100 g Purina rabbit Chow supplemented by whole oats daily
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single instillation to the right eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: substance was not removed
SCORING SYSTEM: according to the Method of Draize at 24, 48 and 72 hours and at 4 and 7 days after dosings.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- other: criteria are not met
- Remarks:
- according to EU CLP (1272/2008 and its updates)
- Conclusions:
- Under the test conditions the test substance is not considered to be an eye irritant in accordance with EU CLP and GHS criteria.
- Executive summary:
To determine the eye irritation potential 0.1 mL of the test substance was instilled once into the right eye of each of six New Zealand White rabbits. Both eyes were examined before testing, at 24, 48 and 72 hours and at 4 and 7 days. The irritation was scored by the method of Draize. The corneal opacity, iritis and chemosis scores were determined to be 0 for all animals. The conjunctival redness scores were determined to be 0.66, 0.66, 0.66, 0.33, 0, and 0.33 for animal 1, 2, 3, 4, 5, and 6, respectively. Based on these scores the test substance was considered not to be irritating to the eyes in accordance with EU CLP and GHS criteria..
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin corrosion: Skin corrosion is not anticipated because the substance is not an eye irritant and did not show irritation at 100% in a guinea pig Buehler test.
Skin irritation: The possible skin irritation potential of the test substance was tested through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 25 µL undiluted test substance. After 42 hours incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The positive control had a mean cell viability of 24% after 15 minutes exposure. The standard deviation value of the percentage viability of three tissues treated identically was less than 5%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 minutes treatment with the substance compared to the negative control tissue was 7.2%. Since the mean relative tissue viability for the test substance was below 50% after 15 minutes treatment the substance is considered to be irritant. Based on these results the substance needs to be classified as Cat 2 and 2A in accordance with EU CLP and GHS, respectively.
Eye irritation OECD TG 405
To determine the eye irritation potential 0.1 mL of the test substance was instilled once into the right eye of each of six New Zealand White rabbits. Both eyes were examined before testing, at 24, 48 and 72 hours and at 4 and 7 days. The irritation was scored by the method of Draize. The corneal opacity, iritis and chemosis scores were determined to be 0 for all animals. The conjunctival redness scores were determined to be 0.66, 0.66, 0.66, 0.33, 0, and 0.33 for animal 1, 2, 3, 4, 5, and 6, respectively. Based on these scores the test substance was considered not to be irritating to the eyes.Based on these results the substance does not need to be classified according the EU CLP and GHS.
Respiratory irritation
For assessing respiratory irritation human data are key for assessing this endpoint. Animal data may be used to indicate effects (ECHA guidance, R7.2.12.1, 2015). No human data are available that indicate respiratory effects. In a 90-day inhalation study with an analogue Terpineol-multi no respiratory irritation was seen. In addition, the substance is not corrosive or a severe eye irritant and therefore respiratory irritation is not anticipated either (ECHA guidance, R7.2.13.1, 2015).
Justification for classification or non-classification
Skin corrosion: The substance does not need to be classified for corrosion because no corrosion is anticipated based on e.g. absence of eye irritation and absenc of skin irritation in a guinea pig Buehler test in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its updates.
Skin irritation: Based on the positive results in the skin irritation test the substance needs to be classified as a skin irritant. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its updates: this results in skin irritation, Category 2, H315: Causes skin irritation.
Eye irritation: Based on the negative results in the eye irritation tests classification for eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its updates.
Respiratory irritation: The substance does not need to be classified for respiratory irritation in absence of human data and other data in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its updates.
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.