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EC number: 412-300-2 | CAS number: 139504-68-0 AMBER CORE
- 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, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 to 26 December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): 1-(2-tert-butyl cyclohexyloxy)-2-butanol cited as P#620
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Ltd., Petersfield, Hampshire, UK
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.8 to 3.0 kg
- Housing: housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard diet SDS Stanrab (P), ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light
IN-LIFE DATES: From: To: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- The eye was not rinsed after the instillation of the test item.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and then 24, 48 and 72 hrs, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize scale according to the OECD guideline No. 405
TOOL USED TO ASSESS SCORE: handheld lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Dulling of the cornea was observed in all three animals one hour after instillation. By the following day corneal opacities had developed which were present 4 days after instillation in 2 animals but has resolved 7 days after instillation.
No iridial inflammation was observed.
Injection of the bood vessels to diffuse crimson colour of the conjunctivae with or without slight swelling was seen in all three animals. Conjunctival irritation had resolved four days after instillation. - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Table 7.3.2/1:Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
D/D/D |
0/0/0 |
2/2/2 |
1/1/1 |
24 h |
1/1/1 |
0/0/0 |
2/1/1 |
1/0/0 |
48 h |
1/2/1 |
0/0/0 |
1/1/1 |
0/1/0 |
72 h |
1/2/1 |
0/0/0 |
1/1/1 |
0/1/0 |
Average 24h, 48h, 72h |
1/1.7/1 |
0.0/0.0/0.0 |
1.3/1/1 |
0.3/0.7/0 |
Reversibility*) |
c |
- |
c |
c |
Average time (day) for reversion**) |
7 |
- |
4 |
4 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which eye irritation signs in the last animal were observed
D: Dulling of the cornea
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test item 1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) induced a reversible eye irritation, with a mean score for cornea opacity ≥1 for at least 2/3 animals. The test item is therefore classified as irritating to eyes in Category 2 (H319, Causes serious eye irritation) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) but is not classified for eye irritation according to the criteria of the Annex VI of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed according to the OECD No. 405, and in compliance with the GLP, 0.1 mL of undiluted 1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) (purity of 89.01%) was instilled into the lower evertid lid of one eye of 3 male New Zealand White Rabbit. After the instillation the substance was not remained. Animals were then observed for 7 days for eye edema (chemosis) and erythema (conjunctivae) of the conjunctive, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the instillation of the substance. The mean individual scores were calculated within 3 scoring times (24, 48 and 72 hrs).
The mean individual scores were 0.3/0.7/0.0 for chemosis, 1.3/1/1 for conjunctival erythema, 1/1.7/1 for corneal opacity and 0.0/0.0/0.0 for iris lesion. These observed effects were all reversible within 7 days.
Under the test conditions, the test item 1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) induced a reversible eye irritation, with a mean individual score for cornea opacity ≥1 for at least 2/3 animals. The test item is therefore classified as irritating to eyes in Category 2 (H319, Causes serious eye irritation) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) but is not classified for eye irritation according to the criteria of the Annex VI of the Directive 67/548/EEC.
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.
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