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EC number: 947-851-2 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 2018 to 02 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- (2017)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- (2010)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D,L- Menthol / D,L-Isomenthol
- Molecular formula:
- C10H20O
- IUPAC Name:
- D,L- Menthol / D,L-Isomenthol
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Source: Slaughterhouse (AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany)
- Number of animals: Not specified
- Characteristics of donor animals (e.g. age, sex, weight): 9-month-old cattle
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eyes were collected and transported in HBBS containing 1 % (v/v) Penicillin/Streptomycin in a suitable container under cooled conditions.
- Time interval prior to initiating testing: Not specified
- indication of any existing defects or lesions in ocular tissue samples: All eyes were checked for unacceptable defects by removing them from the storage solution and examining them. Those exhibiting defects were discarded.
- Indication of any antibiotics used: The cattle eyes were stored in HBSS containing 1% Penicillin/Streptomycin during transportation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml was introduced onto the epithelium of the cornea.
- Concentration (if solution): The test material was prepared as a 20 % suspension (w/v) in saline.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): 0.9% NaCl
- Lot/batch no. (if required): Not specified
- Purity: Not specified - Duration of treatment / exposure:
- The test consisted of the application of the 20 % (w/v) suspension in saline of the test item to the fresh bovine cornea; followed by an initial opacity measurement. After exposure, the cornea was thoroughly rinsed to remove the test item and incubated for 240 minutes in incubation medium. After incubation in the medium, opacity measurements and permeability values were determined after a 90 minutes incubation period in sodium fluorescein.
- Duration of post- treatment incubation (in vitro):
- 90 +- 5 minutes at 32 +-1°C
- Number of animals or in vitro replicates:
- Three test replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- Preparation: The eyes were checked for defects such as opacity, scratches, pigmentation and vascularization by removing them from the HBSS containing 1 % (v/v) Penicillin/Streptomycin.
QUALITY CHECK OF THE ISOLATED CORNEAS : All eyes were checked macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
NUMBER OF REPLICATES : Three
NEGATIVE CONTROL USED : Physiological saline
SOLVENT CONTROL USED (if applicable) : Not applicable
POSITIVE CONTROL USED : 10% (w/v) Benzalkonium chloride in 0.9% (w/v) NaCl (saline)
APPLICATION DOSE AND EXPOSURE TIME : 0.75 ml was introduced onto the epithelium of the cornea.
TREATMENT METHOD: Closed chamber
POST-INCUBATION PERIOD: 90 minutes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Not specified
- POST-EXPOSURE INCUBATION: 240 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance (I = luminous flux per area, unit: lux) by a Opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (OD490)
- Others (e.g, pertinent visual observations, histopathology): Not specified
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
In vitro score range UN GHS
≤ 3 No Category
> 3 ≤ 55 No prediction can be made
>55 Category 1
DECISION CRITERIA: The decision criteria for the IVIS cut-off values for identifying test chemicals as inducing serious eye damage was used for the study.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item Mean
- Value:
- 21.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not applicable
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The first negative control value was outside the acceptance criteria range of 0.86 – 1.64. Due to this, the experiment was repeated twice. The overall IVIS mean for the negative control was 1.03, which was within the acceptance criteria range.
- Acceptance criteria met for positive control: The positive control value of 108.55 was within the acceptance criteria range of 98.30 – 138.03.
Any other information on results incl. tables
Table 1: results after 240 minutes exposure period.
Test Group |
Opacity value = Difference (t240-t0) of Opacity
|
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposedin vitroIrritancy Score |
||
|
|
Mean |
|
Mean |
|
1.03 |
No category |
Negative control |
1 |
0.33 |
0.045 |
0.046 |
1.68 |
||
0 |
0.044 |
0.66 |
|||||
0 |
0.050 |
0.75 |
|||||
Positive control |
95.67* |
0.627* |
105.07 |
108.55 |
Category 1 |
||
103.67* |
0.735* |
114.69 |
|||||
10.67* |
0.483* |
105.91 |
|||||
Test item |
8.67* |
0.964* |
23.12 |
21.33 |
No prediction can be made |
||
7.67* |
0.880* |
20.86 |
|||||
10.67* |
0.623* |
20.01 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Not corrosive or a severe irritant to the eye but study is not sufficient for hazard assessment
- Conclusions:
- In conclusion, under the reported experimental conditions the test item did not cause serious eye damage (Category 1: CLP/GHS). However, the study is not sufficient to be used for hazard classification under the CLP regulation.
- Executive summary:
The study is a GLP-compliant study following OECD guideline 437 and is therefore reliable without restrictions (Klimisch 1). A 20 % (w/v) suspension in saline of the test item was applied directly on top of the corneas. The positive control mean in vitro irritancy score of 108.55 was within two standard deviations of the current historical positive control mean. The negative control values for opacity and permeability (1.03) were less than the upper limits of the laboratory historical range. The validity criteria for the study was therefore met. The test item had an In vitro Irritancy score of 21.33. Based on this result the test item did not cause serious eye damage (Category 1: CLP/GHS); however, this study is not sufficient to be used for hazard classification under CLP regulation.
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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