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EC number: 946-886-0 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04-17 February 2014
- 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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 10 January 2013
Test material
- Reference substance name:
- (αS,1R)-α-3,3-trimethyl-cyclohexanemethanol
- Cas Number:
- 49817-42-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- (αS,1R)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (αR,1S)-α-3,3-trimethyl-cyclohexanemethanol
- Cas Number:
- 49817-52-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- (αR,1S)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (1R-trans)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-55-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R-trans)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (1S-trans)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-44-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1S-trans)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (R*,R*)-α,3,3-trimethyl-cyclohexanemethanol
- Molecular formula:
- C10H20O
- IUPAC Name:
- (R*,R*)-α,3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (S*,S*)-α-3,3-trimethyl-cyclohexanemethanol
- Molecular formula:
- C10H20O
- IUPAC Name:
- (S*,S*)-α-3,3-trimethyl-cyclohexanemethanol
- Reference substance name:
- (1R-cis)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-43-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R-cis)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- (1S-cis)-2,6,6-trimethyl-cycloheptanol
- Cas Number:
- 49817-56-3
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1S-cis)-2,6,6-trimethyl-cycloheptanol
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No.: MP60-16/12/2013
Purity: 71.6% (sum of the two main constituents)
Name of test material (as cited in study report): α-3,3-TRIMETHYLCYCLOHEXANEMETHANOL MULTICONSTITUENT
Physical state: colourless to slightly yellow liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 17 December 2013
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
In vitro test system
- Test system:
- human skin model
- Remarks:
- human reconstructed epidermis (tissues)
- Source species:
- human
- Cell type:
- other: human reconstructed epidermis (tissues)
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Supplier: SkinEthic Laboratories, Lyon, France.
Selection: At receipt, the pH (color of the agar medium) and temperature indicators were checked to ensure the good quality of the tissues before use.
Storage conditions: At receipt, the living EPISKIN™ tissues were kept at room temperature in their packaging until required.
Description: The EPISKIN™ model consists of an airlifted, living, multilayered epidermal tissue construction (surface 0.38 cm2), reconstructed from normal human epidermal keratinocytes for 13 days and produced in polycarbonate inserts in a serum-free and chemically defined medium. The model features a normal ultra-structure and is functionally equivalent to human in vivo epidermis.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: not applicable
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL ± 2 μL of the test item was applied to the epidermis surface.
- Concentration (if solution): undiluted
CONTROLS
- Negative control: 10 μL ± 2 μL of Dulbecco’s Phosphate-Buffered Saline (D-PBS)
- Positive control: 10 μL ± 2 μL of 5 % (w/v) aqueous solution of Sodium Dodecyl Sulfate (SDS) - Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 15 minutes.
At the end of the exposure period, tissues were rinsed and incubated at 37 °C, 5 % CO2 in a humidified incubator for 42 h. - Number of animals:
- Triplicate tissues for test item, negative and positive controls
- Details on study design:
- A new 12-well plate was used for each test and control items: one plate for the test item, one plate for the negative control and one plate for the positive control. Each item was applied onto triplicate tissues.
PRE-INCUBATION OF THE TISSUES ON THEIR DAY OF ARRIVAL (DAY 0)
A volume of 2 mL of pre-warmed maintenance medium was added to the first column of 3 wells of 12-well plates (one plate per item). Then, each EPISKIN™ tissue was transferred into the maintenance medium pre-filled wells (three tissues per plate). The plates were incubated at 37 °C, 5 % CO2 in a humidified incubator for at least 24 h (± 2 h).
TREATMENT OF TISSUES (DAY 1)
A volume of 2 mL of pre-warmed maintenance medium was pipetted into the second column of 3 wells of the 12-well plates for each item, respectively. Then, each test or control item was applied on three tissues for an exposure period of 15 minutes. The items were applied topically to the corresponding tissues and gently spread over the epidermis surfaces to ensure uniform covering of the tissues. The tissues were processed (treatment and rinsing) in the same order and at regular time-intervals to ensure each tissue received an equal exposure period.
The exposure of the tissues to the test and control items was performed at room temperature for 15 minutes (± 1 minute).
RINSING OF TISSUES AND INCUBATION FOR 42 HOURS (DAY 1)
At the end of the treatment period, each tissue was removed from the well of the treatment plate, and rinsed with D-PBS to remove any residual test or control items. The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well and the plates were incubated at 37 °C, 5 % CO2 in a humidified incubator for 42 h.
MTT VIABILITY ASSAY (DAY 3)
On Day 3, following the 42 hour post-exposure incubation period: MTT test (MTT Loading/Formazan Extraction) was performed and tissues were incubated for 3 h (± 5 minutes) at 37 °C, 5 % CO2 in a humidified incubator.
OPTICAL DENSITY MEASUREMENTS (DAY 6)
On Day 6, at the end of the formazan extraction period: The optical density was measured at 570 nm using a plate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Evaluation of the coloration of tissues at the end of the MTT incubation period: All treated tissues appeared white which was considered to be indicative of dead tissues.
Following a 15 minutes exposure and 42 h of recovery period, the relative mean viability of the tissues treated with the test item was 4 % with a Standard Deviation of 0 % as assessed by the MTT assay.
Any other information on results incl. tables
Table 7.3.1/1: Individual and mean corrected OD values and tissue viabilities for the test item, the negative and positive controls
Group |
Tissue No. |
OD measurements |
Mean ODblank |
cOD |
Mean cOD |
Viability (%) |
||
1st |
2nd |
1st |
2nd |
|
|
|||
Negative control |
1 |
0.993 |
1.027 |
0.037
|
0.956 |
0.990 |
0.973 |
101 |
2 |
0.975 |
0.988 |
0.938 |
0.951 |
0.945 |
98 |
||
3 |
1.019 |
1.028 |
0.982 |
0.991 |
0.987 |
102 |
||
Positive control |
1 |
0.091 |
0.090 |
0.037
|
0.054 |
0.053 |
0.054 |
6 |
2 |
0.136 |
0.130 |
0.099 |
0.093 |
0.096 |
10 |
||
3 |
0.096 |
0.088 |
0.059 |
0.051 |
0.055 |
6 |
||
Test item |
1 |
0.073 |
0.076 |
0.037
|
0.036 |
0.039 |
0.038 |
4 |
2 |
0.079 |
0.072 |
0.042 |
0.035 |
0.039 |
4 |
||
3 |
0.070 |
0.069 |
0.033 |
0.032 |
0.033 |
3 |
OD = optical density
cOD = blank corrected optical density
Table 7.3.1/2: Mean tissue viability and Standard Deviations for the test item, the negative and positive controls
Group |
cOD |
Viability (%) |
||
Mean |
SD |
Mean |
SD |
|
Negative control |
0.968 |
0.021 |
100 |
2 |
Positive control |
0.068 |
0.024 |
7 |
2 |
Test item |
0.036 |
0.003 |
4 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is classified in category 2 (H315) according to CLP Regulation (EC) No 1272/2008 and UN GHS.
- Executive summary:
An in vitro skin irritation study was performed according to OECD Guideline 439 and in compliance with GLP, using the EPISKINTM reconstructed human epidermis model.
The test item was applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 h at 37°C, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colorimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability). In the preliminary tests, the test item was found not to have direct MTT reducing properties or coloring potential.
All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
All treated tissues appeared white which was considered to be indicative of dead tissues. Following a 15 minutes exposure and 42 h of recovery period, the relative mean viability of the tissues treated with the test item was 4% with a Standard Deviation of 0%. As the mean viability was < 50 % the results met the criteria for an irritant response.
Therefore, the test material is classified in category 2 (H315) according to CLP Regulation (EC) No 1272/2008 and UN GHS.
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