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EC number: 203-354-6 | CAS number: 106-02-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- From 2004-10-04 to 2004-10-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study performed according to OECD test guideline No. 405 and in compliance with GLP. The study was fully reliable (Klimisch score = 1), however the reliability score was lowered to 2 which is the maximum score for read-across. The supporting substance is considered adequate for read-across purpose (see Iuclid section 13 for justification).
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:
- 2 004
- Report date:
- 2004
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)
- Version / remarks:
- adopted 2002-04-24
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2000-08-02
Test material
- Reference substance name:
- A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one
- EC Number:
- 422-320-3
- EC Name:
- A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one
- IUPAC Name:
- 422-320-3
- Test material form:
- other: liquid
- Details on test material:
- - Chemical name: E/Z-Oxacyclohexadec-12/13-en-2-one
- Physical state: clear, colourless to light yellow liquid
- Storage condition of test material: cool, in full tightly closed containers, in a dark place
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at dosing: approx. 4.5 - 5.5 months
- Weight at study initiation: 2.2 kg to 2.7 kg
- Housing: during the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 400 mm X 500 mm X 370 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönenwalde, Germany); for 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- Diet (ad libitum before and after the exposure period): ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum before and after the exposure period): tap water
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 3 °C (maximum range)
- Relative humidity: 30 % - 70 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item was administered per eye (single instillation).
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: according to the Draize scale
Any further lesions are listed.
TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours after administration the eyes were treated additionally with fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, D-79108 Freiburg) and examined.
OBSERVATIONS:
General criteria: body weight of all animals was measured at the beginning of the study. Behaviour and food consumption were monitored.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1, #2 & #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1, #2 & #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1 & #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1, #2 & #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, in one animal until 24 hours after instillation.
In addition, secretion was observed in two animals 1 hour after instillation. Chemosis was not observed during the observation period.
The cornea and iris were not affected by instillation of the test item.
The 24-hour fluorescein test: no pathological findings. - Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|
Opacity (/4) |
Redness (/3) |
Chemosis (/4) |
||
1 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0* / 0* |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 1 / 0 |
0 / 0 / 0 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0.33 / 0 |
0 / 0 / 0 |
Reversibility*) |
- |
- |
c. |
c. |
Average time (unit) for reversion |
- |
- |
48 h |
72 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
* secretion
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- 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 of the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed according to the OECD test guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 3 male Himalayan rabbit. The eyes were not rinsed after the instillation of the test item. The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. 24 hours after administration the eyes were treated additionally with fluorescein and examined. 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.
Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, in one animal until 24 hours after instillation. In addition, secretion was observed in two animals 1 hour after instillation. Chemosis was not observed during the observation period. The cornea and iris were not affected by instillation of the test item.
The calculated mean score for each individual lesion for each animal within 3 scoring times (24, 48 and 72 h) were 0.00 / 0.33 /0.00 for redness, and 0.00 / 0.00 /0.00 for chemosis, discharge, iris and corneal lesions.
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 of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
The supporting substance is considered adequate for read-across purpose (see Iuclid section 13 for justification).
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