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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-150-6 | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 04 to 14, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- [(2S)-3-methoxy-2-methylpropyl]benzene
- Molecular formula:
- C11H16O
- IUPAC Name:
- [(2S)-3-methoxy-2-methylpropyl]benzene
- Reference substance name:
- [(2R)-3-methoxy-2-methylpropyl]benzene
- Molecular formula:
- C11H16O
- IUPAC Name:
- [(2R)-3-methoxy-2-methylpropyl]benzene
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Storage condition of test material: Stored at room temperature, away from the light and heat (tox specific)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BERTHO, 22120 Yffiniac, France
- Weight at study initiation: 2.8 kg (average weight)
- Housing: Animals were housed individually on floor grid.
- Diet: Complete pelleted rabbit maintenance diet (Energie H326, COFNA, 37000 - Tours, France)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: Environmental conditions and controls were in accordance with the requirements of the 86/609/EEC guideline.
IN-LIFE DATES: From: August 04, 1997 To: August 14, 1997.
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:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation and then on Days 5-11
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: Draize scale, as described in the OECD guideline No. 405.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - At 1 h after instillation: A moderate irritation of the conjunctivae (crimson coloration, tumefaction, important discharge) was observed in all animals and a slight congestion of the iris was noted in one animal.
- At 24 h after instillation: The discharges had nearly disappeared and a conjunctival enanthema was noted in all animals with a very slight oedema in two of them. Marked redness (index 2) was observed and a diffuse area of cornea opacity was reversible within 24 h in one animal.
- At 72 h after instillation: No ocular reaction was observed in one animal. A slight palpebral irritation (enanthema of index 2 and oedema of index 1) was noted in the two other animals.
- The chemosis was reversible within 7 days and the palpebral redness disappeared 11 days after instillation. - 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 (Day 1) |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 0 / 0 |
2 / 2 / 2 |
1 / 1 / 1 |
3 / 3 / 2 |
24 h (Day 1) |
1 / 0 / 0 |
1 / 0 / 0 |
0 / 0 / 0 |
2 / 1 / 1 |
1 / 0 / 1 |
1 / 0 / 0 |
48 h (Day 2) |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
2 / 1 / 1 |
1 / 0 / 1 |
1 / 0 / 0 |
72 h (Day 3) |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
2 / 0 / 2 |
1 / 0 / 1 |
1 / 0 / 1 |
Day 5 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
2 / - / 2 |
1 / - / 1 |
1 / - / 1 |
Day 6 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
2 / - / 2 |
1 / - / 1 |
0 / - / 0 |
Day 7 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
2 / - / 2 |
0 / - / 0 |
0 / - / 0 |
Day 8 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
1 / - / 1 |
0 / - / 0 |
0 / - / 0 |
Day 9 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
1 / - / 1 |
0 / - / 0 |
0 / - / 0 |
Day 10 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
1 / - / 1 |
0 / - / 0 |
0 / - / 0 |
Day 11 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
0 / - / 0 |
Average 24, 48 and 72 h |
0.3 / 0.0 / 0.0 |
0.3 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
2.0 / 0.7 / 1.3 |
1.0 / 0.0 / 1.0 |
1.0 / 0.0 / 0.3 |
Reversibility |
Completely reversible |
Completely reversible |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
48 h |
48 h |
- |
72 h to 11 days |
24 h to 7 days |
24 h to 6 days |
Key:
- : No reading
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 eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according 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 the right eye of 3 female New Zealand White rabbits. The lids are then gently held together for about one second in order to prevent loss of the material. The left eye remained untreated and served as control. Animals were observed at 1, 24, 48 and 72 h after test material instillation, and then on Days 5-11. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
A moderate irritation of the conjunctivae was observed in all animals and a slight congestion of the iris was noted in one animal at 1 h after instillation. 24 h after instillation, the discharges had nearly disappeared and a conjunctival enanthema was noted in all animals with a very slight oedema in two of them. Marked redness was observed and a diffuse area of cornea opacity was reversible within 24 h in one animal. No ocular reaction was observed in one animal at 72 h. A slight palpebral irritation was noted in the two other animals. The chemosis was reversible within 7 days and the palpebral redness disappeared 11 days after instillation.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.3 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 2.0 / 0.7 / 1.3 for conjunctivae score and 1.0 / 0.0 / 1.0 for chemosis score.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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.