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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-289-8 | CAS number: 80-54-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable deviations (multi patch study was performed with more than one chemical tested per animal, short observation period)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (multi patch study was performed with more than one chemical tested per animal)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- EC Number:
- 201-289-8
- EC Name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- Cas Number:
- 80-54-6
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(4-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- - Analytical purity: 97.8%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand White Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
- Housing: individually
- Diet: ad libitum, (S.Q.C. Standard Rabbit Diet, Special Diet Services Limited, Witham, Essex)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 40-80
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.5 ml applied on lint patches
- Concentration (if solution): undiluted (100%) - Duration of treatment / exposure:
- 4h
- Observation period:
- 7d
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: flank, immediately caudal to the last rib
- Type of wrap: 'Elastoplast' elastic adhesive bandage 10cm wide
- Restraining of animals: Yes
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing of site with cotton wool soaked in warm water
- Time after start of exposure: 4h
SCORING:
- Scoring time: at least 1h, 24h, 48h, 72h, 7d after removal of patch
Scoring system: Draize 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 mm) = 3
- Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h;48h; 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Marked desquamation present in all 3 animals after 7 days. Slight erythema in one animal and well-defined erythema in 2 animals still present after 7 days observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h;48h; 72;
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Slight edema still present in 2 animals after 7 days
- Irritant / corrosive response data:
- For assessment of the skin irritation, the mean score for all animals at time points 24, 48 and 72 h was used. The scores of each of the 3 animals for the time points 24, 48 and 72h were summed and divided by the 3, the number of examinations that the figures were taken from. The mean value for each of the 3 animals was summed and divided by 3 for the number of animals from which the values were taken from. The values obtained on assessing oedematous reaction were similarly treated.
Any other information on results incl. tables
Table 1: Summary of results of skin irritation study in rabbit
Readings |
Animal |
Erythema |
Edema |
Further findings |
1h |
1 |
0 |
1 |
|
2 |
2 |
2 |
||
3 |
1 |
2 |
||
24h |
1 |
1 |
2 |
|
2 |
2 |
2 |
||
3 |
2 |
3 |
||
48h |
1 |
2 |
2 |
|
2 |
2 |
3 |
||
3 |
2 |
3 |
||
72h |
1 |
2 |
2 |
|
2 |
2 |
3 |
||
3 |
3 |
3 |
||
7d |
1 |
1 |
0 |
Marked desquamation |
2 |
2 |
2 |
Marked desquamation |
|
3 |
2 |
2 |
Marked desquamation |
|
Mean (24h-72h) |
1 |
1,7 |
2,0 |
|
2 |
2,0 |
2,7 |
||
3 |
2,3 |
3,0 |
||
Mean (24h-72h) |
all animals |
2,0 |
2,6 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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.