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EC number: 296-618-5 | CAS number: 92875-02-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Fusanus spicatus, Santalaceae.
- 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:
- June 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
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)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- see Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1) as amended B.47
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- EC Number:
- 204-102-8
- EC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- Cas Number:
- 115-71-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
- Reference substance name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- EC Number:
- 201-027-2
- EC Name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- Cas Number:
- 77-42-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
- Reference substance name:
- (2E,6E)-3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Cas Number:
- 106-28-5
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2E,6E)-3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Reference substance name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Cas Number:
- 78339-53-4
- Molecular formula:
- C15H22O
- IUPAC Name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Reference substance name:
- (Z,6R)-2-methyl-6-(4-methylcyclohexa-1,4-dien-1-yl)hept-2-en-1-ol
- Cas Number:
- 698365-10-5
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z,6R)-2-methyl-6-(4-methylcyclohexa-1,4-dien-1-yl)hept-2-en-1-ol
- Reference substance name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Cas Number:
- 78148-59-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Reference substance name:
- (2Z,6S)-2-Methyl-6-(4-methyl-1,3-cyclohexadien-1-yl)-2-hepten-1-ol
- Cas Number:
- 698365-09-2
- Molecular formula:
- C15H24O
- IUPAC Name:
- (2Z,6S)-2-Methyl-6-(4-methyl-1,3-cyclohexadien-1-yl)-2-hepten-1-ol
- Reference substance name:
- Nerolidol
- EC Number:
- 205-540-2
- EC Name:
- Nerolidol
- Cas Number:
- 142-50-7
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol
- Test material form:
- liquid
- Details on test material:
- Batch no. SS181004
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- Name Fusanus spicatus, ext.
Batch no. SS181004
Appearance clear, mustard-yellow liquid
Composition Main components: Z-α-santalol; epi-α-bisabolol; Z-β-santalol; epi-β-santalol; Z-α-trans-bergamotol; E,E-farnesol; Z-nuciferol; Z-lanceol
Purity not applicable, UVCB
Homogeneity homogeneous
Expiry date 16. Jul. 2021
Test animals / tissue source
- Species:
- other: eyes from Bos primigenius Taurus (fresh bovine corneas)
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour 10 minutes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL of the appropriate liquid (test substance, negative control and positive control, in triplicates) were added through the refill hole in the anterior holder on the corneas
- Duration of treatment / exposure:
- Exposure time of the controls and test item on the corneas was 10 minutes at 32 ±1 °C.
- Duration of post- treatment incubation (in vitro):
- After thorough rinsing the anterior chambers with cMEM (complete MEM) with phenol red and final rinsing with cMEM without phenol red, the anterior chambers were filled with cMEM without phenol red and the cornea holders were stored for additional 2 hours at 32 ±1 °C (post-incubation).
- Number of animals or in vitro replicates:
- test item, negative control and positive control were tested in triplicates each.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1. Measurement
- Value:
- 2.67
- Vehicle controls validity:
- not applicable
- Remarks:
- substance was applied neat
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2. Measurement
- Value:
- 2.36
- Vehicle controls validity:
- not applicable
- Remarks:
- substance was applied neat
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3. Measurement
- Value:
- 2.45
- Vehicle controls validity:
- not applicable
- Remarks:
- substance was applied neat
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of three independent experiments
- Value:
- 2.49
- Vehicle controls validity:
- not applicable
- Remarks:
- substance was applied neat
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Validity: According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The mean IVIS of the negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given as follows:
Mean IVIS of negative control HBSS ≤ 3 (criterion) was found 0.36 and thus, is valid
Mean IVIS of positive control (DMF undiluted) in historical control range (54.01 - 141.57) was found as 110.04 and thus, considered valid.
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Assessment:
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Classification Scheme
IVIS ≤ 3 No category according to UN GHS
IVIS > 3 and ≤ 55 No prediction can be made according to UN GHS
IVIS > 55 Eye damage Category I according to UN GHS
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item Fusanus spicatus, ext. showed no effects on the cornea of the bovine eye. The calculated mean IVIS (In Vitro Irritancy Score) was 2.49.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item.
Any other information on results incl. tables
Opacity and Permeability Values
Theilluminance(unit: LUX) values which were measured before and after exposure are given in the following table:
Table1-aIlluminance Values
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
997 |
1031 |
1041 |
1047 |
1042 |
1036 |
1025 |
1024 |
993 |
(I) Measured values after exposure |
991 |
1025 |
1030 |
980 |
979 |
972 |
339 |
320 |
326 |
Rep. = Replicate
The values in the following tables present the calculated opacity values, according to evaluation:
Table1-b Opacity Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
3.72 |
2.30 |
1.90 |
Opacity after exposure |
3.98 |
2.54 |
2.34 |
Opacity Difference |
0.26 |
0.24 |
0.44 |
Mean Opacity Difference |
0.32 |
Rep. = Replicate
Table1-c Opacity Values Test Item and Positive Control
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
1.66 |
1.86 |
2.10 |
2.54 |
2.58 |
3.90 |
Opacity |
4.47 |
4.51 |
4.83 |
87.46 |
94.99 |
92.52 |
Opacity |
2.81 |
2.66 |
2.73 |
84.91 |
92.41 |
88.62 |
Opacity corrected |
2.49 |
2.34 |
2.42 |
84.60 |
92.09 |
88.30 |
Mean Opacity |
2.42 |
88.33 |
Rep. = Replicate
For the permeability measurement, three replicates for each treatment group were measured three times. cMEM without phenol red was measured as blank value as well. The optical density values at 492 nm are given in the following tables:
Table 1-d Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.034 |
2. Measurement |
0.036 |
3. Measurement |
0.035 |
Mean |
0.035 |
Table1-e Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measure-ment |
0.045 |
0.036 |
0.036 |
0.051 |
0.040 |
0.041 |
1.207 |
1.346 |
1.886 |
2. Measure-ment |
0.044 |
0.033 |
0.034 |
0.049 |
0.039 |
0.041 |
1.198 |
1.359 |
1.856 |
3. Measure-ment |
0.045 |
0.033 |
0.034 |
0.049 |
0.038 |
0.038 |
1.210 |
1.356 |
1.945 |
1. Measure-ment – blank |
0.0100 |
0.0010 |
0.0010 |
0.0160 |
0.0050 |
0.0060 |
1.1720 |
1.3110 |
1.8510 |
2. Measure-ment – blank |
0.0090 |
-0.0020 |
-0.0010 |
0.0140 |
0.0040 |
0.0060 |
1.1630 |
1.3240 |
1.8210 |
3. Measure-ment – blank |
0.0100 |
-0.0020 |
-0.0010 |
0.0140 |
0.0030 |
0.0030 |
1.1750 |
1.3210 |
1.9100 |
Mean of each replicate |
0.0097 |
-0.0010 |
-0.0003 |
0.0147 |
0.0040 |
0.0050 |
1.1700 |
1.3187 |
1.8607 |
Mean of the 3 replicates |
0.0028 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0119 |
0.0012 |
0.0022 |
1.1672 |
1.3159 |
1.8579 |
Corrected mean of the 3 replicates |
-- |
0.0051 |
1.4470 |
Rep. = Replicate
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table9.2‑a IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.41 |
0.36 |
31.32% |
0.23 |
|||
0.44 |
|||
Test Item |
2.67 |
2.49 |
6.43% |
2.36 |
|||
2.45 |
|||
Positive Control |
102.11 |
110.04 |
6.55% |
111.83 |
|||
116.17 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study (OECD 437), the test item Fusanus spicatus, ext. showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 2.49 and accordingly, the substance is considered non-irritant to eyes according to CLP (Regulation EC No 1272/2008).
- Executive summary:
This in vitro study was performed to assess the corneal damage potential ofFusanus spicatus, ext.by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test itemFusanus spicatus, ext.was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
The test item was tested neat.
Under the conditions of this test, the test itemFusanus spicatus, ext.showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 2.49.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
The negative control (HBSS) and the positive control (undiluted dimethylformamide) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. No deviations from the study plan were observed. The test is considered valid.
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