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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 907-235-6 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 4 MAR 1985 to 11 MAR 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : initial body weights of the test animals differ slightly too much
- GLP compliance:
- yes
Test material
- Reference substance name:
- n-undecanal
- IUPAC Name:
- n-undecanal
- Reference substance name:
- 2-methyl decanal
- IUPAC Name:
- 2-methyl decanal
- Reference substance name:
- n/i-undecanal
- IUPAC Name:
- n/i-undecanal
- Details on test material:
- - Name of test material (as cited in study report): n/i-undecanal
- Substance type: colourless
- Physical state: liquid
- Stability under test conditions: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.24 to 2.87 kg
- Housing: suspended metal cages, individually
- Diet: standard laboratory diet (Rabbit Diet, A .W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-61
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The treated and control eyes the animals remained unwashed throughout the observation period.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: basically according to guideline OECD 405
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)
Reeding times: 1, 24, 48 and 72 hours following treatment (if irritation persisted at the 72 h observation additional readings were made at 7, 14 and 21 days)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- : individual scores (mean) 1/0.33/0
- Time point:
- other: 24-48-72 h
- Score:
- 0.78
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- : individual scores (mean) 1/0/1
- Time point:
- other: 24-48-72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Observations at reading times (scores are given for animal#1/#2/#3) :
- 1h: diffuse crimson red colouration of the conjunctivae accompanied by slight swelling in all three animals (conjuctivae redness 2/2/2; chemosis 2/2/2; discharge 2/2/2; all other scores in all animals are 0)
- 24 h: reduction in the level of reaction in all three animals (conjuctivae redness 1/1/1; chemosis 1/0/1; discharge 0/0/0; all other scores in all animals are 0)
- 48 h: the reactions had already ameliorated completely in one rabbit (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 7 days: the remaining two rabbits are fully recovered (all scores are 0)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP Regulation
- Conclusions:
- Under the conditions tested the test item was not irritating to eyes of rabbits.
- Executive summary:
Irritation of the eye was tested in 3 New Zealand white rabbits according to guideline OECD 405. 0.1 mL of test item (purity: not stated, undiluted, not washed out) were instilled into the lower conjunctival sac of the right eye of each rabbit. Slight irritating effects on the conjunctiva (redness; mean score: 0.78) and chemosis (mean score: 0.67) were observed in all animals. All effects were fully reversible within 7 days, and no effects on the cornea or iris were observed, thus the test item is not irritating to the eye (Ruhrchemie AG/Safepharm, 1985).
This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity. Pronounced conjunctival effects seen at 1 hour after treatment are not relevant for classification according to regulation EC/1272/2008. The test substance was therefore not irritating.
This result can be transferred to the registered n-/iso-undecanal. The proportions of n- or iso-undecanal of the test material is not reported. Read Across is therefore considered. Refer to the discussion field of the endpoint summary for detailed justification of read across.
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.