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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-495-7 | CAS number: 689-65-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-03-2016 to 15-03-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Justification for type of information:
- Information as to the availability of the in vivo study is provided in 'attached justification'.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: June 2015; signature: September 2015
Test material
- Reference substance name:
- (4E)-5,9-dimethyldec-4-enal; (4Z)-5,9-dimethyldec-4-enal
- EC Number:
- 943-495-7
- Cas Number:
- 689-65-6
- Molecular formula:
- C12H22O
- IUPAC Name:
- (4E)-5,9-dimethyldec-4-enal; (4Z)-5,9-dimethyldec-4-enal
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: Approximately 4 °C, in the dark
- Other: clear colourless
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: recognised animal supplier
- Age at study initiation: 12 - 52 weeks
- Weight at study initiation: 2.93 or 3.24 kg
- Housing: Individually housed in suspended cages.
- Diet: certified rabbit diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod: 12 hours light / 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Test material was used as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (initial observation); additional observations are made on Days 7 and 14 to assess the reversibility of skin reactions (as appropriate).
- Number of animals:
- 2; following the guideline sequential testing approach
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive (2.5 cm x 2.5 cm cotton gauze patch secured with surgical adhesive tape)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema _________________________________________________________________________0
Very slight erythema (barely perceptible) ________________________________________________1
Well-defined erythema ________________________________________________________________2
Moderate to severe erythema __________________________________________________________3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ________________4
Oedema Formation
No oedema __________________________________________________________________________0
Very slight oedema (barely perceptible) _________________________________________________1
Slight oedema (edges of area well-defined by definite raising) _____________________________2
Moderate oedema (raised approximately 1 millimetre) ____________________________________3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) ___4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); Glossy skin, slight desquamation and reduced regrowth of fur was seen at day 14
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); Glossy skin, slight desquamation and reduced regrowth of fur was seen at day 14
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score (n=2); see comments above
- Irritant / corrosive response data:
- - Erythema: Well defined erythema (score = 2) and slight edema (score = 2) at treated skin sites were noted immediately, at 1 hour and at 24, 48 and 72 hours after patch removal. The erythema extended approximately 10 mm beyond the test site 1 hour after patch removal and at the 24, 48, 72 Hour and 7 Day observations.
- Edema: and slight edema (score = 2) was noted immediately, at 1 hour and at 24, 48 and 72 hours after patch removal.
- Reversibility of effects:
1. Day 7: Inflammation (erthymea and edema) persisted (score = 2) with light brown discoloration of the epidermis and loss of skin elasticity and flexibility were noted at both treated sites.
2. Day 14: Inflammation (erthymea and edema) had fully reversed (score = 0) in all treated sites; however, glossy skin, slight desquamation and reduced regrowth of fur were noted at both treated skin sites at the 14 Day observation. - Other effects:
- Light brown discoloration of the epidermis and loss of skin elasticity and flexibility were noted at both treated skin sites at the 7 Day observation. Glossy skin, slight desquamation and reduced regrowth of fur were noted at both treated skin sites at the 14 Day observation.
Both organisms showed expected body weight gain during the course of the study. There was no clinical signs of toxicity reported during the duration of the test.
Any other information on results incl. tables
Table 1. Individual skin reactions
Skin Reaction |
Observation Time |
Individual Scores |
|
Number and Sex |
|||
#1 (Female) |
#2 (Female) |
||
Erythema/Eschar Formation |
Immediately |
2 |
2 |
1 Hour |
2R |
2R |
|
24 Hours |
2R |
2R |
|
48 Hours |
2R |
2R |
|
72 Hours |
2R |
2R |
|
7 Days |
2RBrLeLf |
2RBrLeLf |
|
14 Days |
0GDFr |
0GDFr |
|
Edema Formation |
Immediately |
2 |
2 |
1 Hour |
2 |
2 |
|
24 Hours |
2 |
2 |
|
48 Hours |
2 |
2 |
|
72 Hours |
2 |
2 |
|
7 Days |
2 |
2 |
|
14 Days |
0 |
0 |
R = Reaction extended approximately 10 mm beyond the test site
Br = Light brown discoloration of the epidermis
Le = Loss of skin elasticity
Lf = Loss of skin flexibility
G = Glossy skin
D = Slight desquamation
Fr = Reduced regrowth of fur
Mean scores per organism at 24, 48 and 72h:
Erythemea/Escar Formation:
1: total = 2.0 ; mean score = 2.0
2: total = 2.0; mean score = 2.0
Edema Formation:
1: total = 2.0; mean score = 2.0
2. total = 2.0; mean score = 2.0
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test material is considered to be irritating.
- Executive summary:
The study was performed to OECD TG 404, EU Method B.4 and the Japanese MAFF (2000) and US EPA OPPTS 870.2500 to assess the primary skin irritancy potential of the test substance in accordance with GLP in New Zealand White rabbits. Following single 4-Hour, semi-occluded applications to the intact rabbit skin. 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the clipped skin to assess the irritancy potential of the test item. The patch was secured in position with a strip of surgical adhesive tape. After 4 hours of exposure to the test substance, the patches were removed and individual dose sites were scored at approximately 1, 24, 48, 72 hours and 7 and 14 days, respectively. A single 4-Hour, semi occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and slight edema at both skin sites at 1 hour, 24 through 72 hours after patch removal. No corrosive effects were noted. Other skin reactions noted were light brown discoloration of the epidermis, loss of skin elasticity and flexibility, glossy skin, slight desquamation and reduced regrowth of fur. Mean scores for following grading at 24, 48 and 72h were 2.0 in erythema and eschar and 2.0 in edema scoring criteria. At day 14, mean scores were zero for erythema and edema, respectively. Glossy skin, slight desquamation and reduced fur growth persisted. Under the conditions of the study, the substance is considered to be a skin irritant.
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.