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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
- Study period:
- July 1996 - July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,5,5-trimethylhexanal
- EC Number:
- 226-603-0
- EC Name:
- 3,5,5-trimethylhexanal
- Cas Number:
- 5435-64-3
- Molecular formula:
- C9H18O
- IUPAC Name:
- 3,5,5-trimethylhexanal
- Details on test material:
- klare, farblose Flüssigkeit
Flüssigkeit erscheint optisch homogen
ph-Wert nicht messbar
Haltbarkeit > 1 Jahr
Reinheit 97% (1H- und 13C-NMR-Spektroskopie)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Mol: Russian/Chbb: HM
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding /Research Centre Ltd., Skensved, Denmark
- Age at study initiation: adult
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: conventional, single-housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days
- sex: male
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 ° C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-fold per hr
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22.07.1996 To:13.08.1996
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,5 cm³ of the test item were applied on 6 cm² skin
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The evaluation is performed 30-60 minutes, 24 h, 48 h und 72 h,
6, 8, 10, 17 and 21 days after patch removal. - Number of animals:
- 3
- Details on study design:
- The rabbits were examined for their general state of health about 24 h before application of the test substance. In the dorsal region the animals were sheared with a small chopper with a cutting height of 1/2 mm.
For the test, three test animals per 0.5 cm³ of the liquid test substance were applied to a skin area of approximately 6 cm.sup.2 and treated with a
coverage . Subsequently, this area was covered with a non-irritating patch and with a semiocculsive bandage
for four hours. After expiry of the exposure time, the dressing was removed and the application area was washed with warm water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.78
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritant / corrosive response data:
- see excecutive summary
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 3,5,5-trimethylhexanal has to be classified as skin irritant according to CLP Regulation (EC) No. 1272/2008
- Executive summary:
The test for acute skin irritation in the rabbit with TRIMETHYLHEXANAL was performed on three animals with an exposure time of 4 hours. The liquid test substance was applied undiluted once to the sheared intact skin.
The administration of the test substance led to severe erythema and oedemas associated with hypodermic hemorrhage 24 h after patch removal in all three animals on the skin. 48 h after patch removal, the skin irritation in two animals remained unchanged.
The surface of the skin was dry. The third animal showed a moderate to severe erythema associated with a slight edema (edges of the application area were clearly defined by the swelling). The skin in the application area was yellowish-colored. After 72 h, the skin irritation in two animals remained unchanged. At the time, a hardening of the skin surface was observed at the time of the appearance of the skin dryness. The third animal exhibited moderate to severe erythema and moderate edema. The skin was still yellowish discolored. 6 days after patch removal, erythema and edema formation on the skin remained strong. The skin in the application area was brownish discolored and hardened. The formed scaly plate was cracked in two animals. On the 8th day of the experiment, an erythema was clearly observed in one animal, and a moderate to severe erythema was observed in two animals. The skin was moderately swollen (about 1 mm thick) in all three animals. The scaly plates on the skin were cracked and in an animal already in detachment. On the tenth day erythema formation was still clear. The animals showed a slight edema of the treated skin. The cracked dandruff plate was in two animals in detachment.
No erythema and edema formation on the skin was observed on observation days 14, 17 and 21. The skin irritations healed completely with the formation of scales, which gradually separated. One animal showed a red shining skin under the detached scales. On the 21st day of the experiment, the skin of the animals was not found. The hair had grown in the application area.
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.