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EC number: 228-958-7 | CAS number: 6379-72-2
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 16 to 20, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (inspected on June 14, 1999 / signed on December 01, 1999)
Test material
- Reference substance name:
- 4-trans-propenylveratrole
- EC Number:
- 228-958-7
- EC Name:
- 4-trans-propenylveratrole
- Cas Number:
- 6379-72-2
- Molecular formula:
- C11H14O2
- IUPAC Name:
- (E)-1,2-Dimethoxy-4-prop-1-en-1-ylbenzene
- Test material form:
- liquid
- Details on test material:
- - Physical state: Yellowish liquid
- Storage condition of test material: 7°C, protected from light and moisture
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißlegg
- Weight at study initiation: 2.5-2.7 kg
- Housing: Animals were housed individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet: Pelleted complete rabbit diet (‘Altromin 2123’ from Altromin, D-32791 Lage, Lippe), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 10 times / h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: October 16, 2000 To: October 20, 2000
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation of test material
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Fluorescein was instilled into eyes of test animals after 24 h reading. Then eyes were rinsed with 20 mL of 0.9 % sodium chloride solution.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.
TOOL USED TO ASSESS SCORE: Eyes (before and after instillation of fluorescein) were examined using hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 x magnification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3 & #4
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3 & #4
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 & #4
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3 & #4
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - 1 h after test material instillation, two animals showed conjunctival vessels definitely injected and a swelling above normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed in one animal. One animal showed an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed.
- 24 h after test material instillation, three animals showed some conjunctival vessels definitely injected. One animal showed no signs of eye irritation.
- 48 h after test material instillation, one animal showed some conjunctival vessels definitely injected. No eye irritation was observed in other animals.
- None of the four animals showed any sign of eye irritation at 72 h. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/1 |
1/1/2/2 |
1/1/1/1 |
0/0/0/0 |
24 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
1/0/1/1 |
0/0/0/0 |
0/0/0/0 |
48 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/1/0 |
0/0/0/0 |
0/0/0/0 |
72 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
Average 24, 48 and 72 h |
0/0/0/0 |
0/0/0/0 |
0/0/0/0 |
0.33/0/0.67/0.33 |
0/0/0/0 |
0/0/0/0 |
Reversibility |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
- |
Average time (unit) for reversion |
- |
- |
24 h |
72 h |
24 h |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 4 female New Zealand White rabbits. The other eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after instillation. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.
1 h after test material instillation, two animals showed conjunctival vessels definitely injected and a swelling above normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed in one animal. One animal showed an iris with markedly deepened folds, congestion swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible as well as a swelling above normal was observed. 24 h after test material instillation, three animals were observed some conjunctival vessels definitely injected. 48 h after test material instillation, one animal showed some conjunctival vessels definitely injected. None of the four animals showed any sign of eye irritation at 72 h.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.33/0.0/0.67/0.33 for redness, 0/0/0/0 for chemosis, 0/0/0/0 for iris lesions and 0/0/0/0 for corneal opacity. The effects observed were all reversible within 72 hours.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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