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EC number: 204-683-8 | CAS number: 124-13-0
- 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:
- 20 December 1993 to 18th January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant 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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octanal
- EC Number:
- 204-683-8
- EC Name:
- Octanal
- Cas Number:
- 124-13-0
- Molecular formula:
- C8H16O
- IUPAC Name:
- octanal
- Reference substance name:
- Aldehyde C8
- IUPAC Name:
- Aldehyde C8
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Aldehyde C8
- Physical state: Clear liquid
- Analytical purity: 99%
- Lot/batch No.: 93/09/20
- Expiration date of the lot/batch: March 1994
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 13 to 15 weeks of age
- Weight at study initiation: 2.9 to 3.6 kg
- Housing: Housed individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: The rabbits were acclimatised but the period of acclimatisation is not specified in the study report.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): Approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial light (0700 - 1900) and 12 hours dark
IN-LIFE DATES: From: 20 December 1993 To: 18 January 1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated contralateral eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.1ml - Duration of treatment / exposure:
- 14 days
- Observation period (in vivo):
- 14 days.
All animals were observed daily for signs of ill health or toxicity. Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7 and 14 days after instillation. - Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided to indicate treated eyes were rinsed after instillation
SCORING SYSTEM: Modified Draize assessment
Cornea :
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible transIucent areas, details of iris slightly obscured 2
Nacreous areas. no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Iris:
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or
injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae:
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Dulling of the cornea was observed one hour after administration
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: No effects observed on the iris
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Dulling of the corneas was observed 1 hour after administration
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Dulling of the cornea was observed one hour after administration
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: No effects observed on the iris
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.11
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Irritant / corrosive response data:
- Corneal opacities developed in two animals. Dulling of the normal lustre of the cornea was seen in one animal. Iridial inflammation was observed in one animal.
A diffuse crimson colouration of the conjunctivae was seen in all three animals and was accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed. The eyes had returned to normal 7 or 14 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
Ocular Reactions observed after instillation of Aldehyde C8:
Rabbit |
Region of the eye |
One hour |
Day after instillation
|
||||||
1 |
2 |
3 |
4 |
7 |
14 |
||||
1* |
Cornea |
D |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
1 |
0 |
|
|
Chemosis |
3 |
2 |
1 |
1 |
1 |
0 |
|
||
2 |
Cornea |
D |
1 |
1 |
1 |
1 |
1 |
0 |
|
Iris |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
3 |
2 |
2 |
2 |
2 |
0 |
|
Chemosis |
3 |
3 |
2 |
2 |
1 |
1 |
0 |
||
3 |
Cornea |
D |
1 |
1 |
1 |
1 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
|
Chemosis |
3 |
2 |
2 |
2 |
2 |
1 |
0 |
* Pilot Animal
D Dulling
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes.
- Executive summary:
In a study conducted in 1994, the potential of the test substance Aldehyde C8 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of 0.1 mL of the test substance undiluted and they were observed for 14 days after instillation. The test substance was administered into one eye of each rabbit with the other eye remaining as the untreated control. Following application, the treated eye elicited corneal opacity. iridial inflammation and well-defined conjunctival irritations. However, all reactions had resolved by14 days after instillation.
Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance should be classified as a Category 2 eye irritant according to Regulation EC No. 1272/2008.
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