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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-603-0 | CAS number: 5435-64-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Read across is applied to a structural analogue
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethylhexanal
- EC Number:
- 204-596-5
- EC Name:
- 2-ethylhexanal
- Cas Number:
- 123-05-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- 2-ethylhexanal
- Details on test material:
- - Name of test material (as cited in study report): Äthylhexanal (German)
- Physical state: liquid
- Analytical purity: ca. 98 %
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.36 kg and 2.00 kg
- Weight at study conclusion: 2.34 kg and 2.11 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): prosumably 2 ml - Duration of treatment / exposure:
- Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h - Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; prosumably 2 ml)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Experiment 1: washing was done for in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50 % (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48- 72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: scale formation in both animals, see table for further details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.83
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: Erythema remained in one animal, see table for further details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: see table for further details
Any other information on results incl. tables
Since irritation data from a 4 h skin exposition model are recommended, results for the available 20 h and the 15 min exposition served as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores. If necroses were reported, erythema scores were given for the surrounding area.
Exposition: |
20 h |
|||
Animal |
Reading |
Erythema |
Edema |
Comment |
1 |
24 h |
2 |
3 |
yellow-red, surrounding area ca. 2-5 cm width |
2 |
24 h |
3 |
3 |
yellow brown, lobule-size with punctual hemorrhage, surrounding area 2-5 cm width |
1 |
48 h |
3 |
3 |
brown, overlapping |
2 |
48 h |
2 |
0 |
yellow, overlapping, application site brown |
1 |
72 h |
3 |
3 |
light brown, necrosis, surrounding area ca. 5 cm width |
2 |
72 h |
|
|
yellow, overlapping, application site brown |
1 |
4 d |
2 |
3 |
light brown, necrosis, surrounding area ca. 5 cm width |
2 |
4 d |
2 |
0 |
superficial yellow brown, necrosis, starting scale formation |
1 |
7 d |
0 |
0 |
light and smooth crust formation, widely overlapping, light scaling |
2 |
7 d |
0 |
0 |
yellow brown, necrosis, scaling |
1 |
8 d |
0 |
0 |
light and smooth crust formation detaching, widely overlapping, light scale formation |
2 |
8 d |
0 |
0 |
yellow brown, necrosis, scaling |
mean |
24-72 h |
2,60 |
2,40 |
|
Exposition: |
15 min |
|||
Animal |
Reading |
Erythema |
Edema |
Comment |
1 |
24 h |
3 |
2 |
overlapping with yellow areas |
2 |
24 h |
3 |
2 |
overlapping |
1 |
48 h |
3 |
2 |
overlapping |
2 |
48 h |
2 |
0 |
light overlapping |
1 |
72 h |
3 |
3 |
overlapping, parchmenty |
2 |
72 h |
3 |
2 |
overlapping |
1 |
4 d |
2 |
0 |
overlapping, parchmenty |
2 |
4 d |
2 |
2 |
starting scale formation |
1 |
7 d |
1 |
0 |
rough scaling |
2 |
7 d |
0 |
0 |
scaling |
1 |
8 d |
1 |
0 |
rough scaling |
2 |
8 d |
0 |
0 |
scaling |
mean |
24-72 h |
2,83 |
1,83 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Executive summary:
This supporting study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance). Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the test substance.
The test substance induced marked Erythema and edema formation even after a 1 min exposure. After 20 h exposure and 8 days observation edemas are questionable while marked scale formation was reported. Scale formation began already after 20 h exposure and 24 h observation. Scale formation is a hint for skin regeneration after skin corrosion.
Substance is irritant to the skin.
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.