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EC number: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 - 15 Oct 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information on purity was given. The reversibility of effects was observed only up to 7 days after removal of the patches.
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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no information on purity; 7-day observation period
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-dimethylbutyl (E)-but-2-enoate
- Molecular formula:
- C10H18O2
- IUPAC Name:
- 1,3-dimethylbutyl (E)-but-2-enoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.14 - 2.76 kg
- Housing: individually in suspended metal cages
- 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): 17 - 20
- Humidity (%): 60 - 68
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap: The treated skin was covered with a gauze patch (2.5 cm x 2.5 cm), which was held in place with two lengths of adhesive strapping (sleek) in the form of a cross. To prevent the animals from interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in ether.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: desquamation was observed on Day 7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Irritant / corrosive response data:
- All test sites showed barely perceptible or well defined erythema with or without minimal oedema 1 h after removal of the patches. Similar reactions were noted after 24 h. By the 48 h observation moderate erythema had developed at 3 test sites while barely perceptible or well defined erythema persisted at the remaining 3 test sites. Minimal oedema was also seen at 5 test sites at this time. Barely perceptible to moderate erythema with or without minimal oedema persisted at all test sites at the 72 h reading. A final observation at Day 7 showed a reduction in the level of reaction when barely perceptible erythema with desquamation was noted at all 6 test sites.
Any other information on results incl. tables
1. Result of the irritation study.
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
1 |
1 |
0 |
1 |
0 |
2 |
1 |
1 |
1 |
2 |
1 |
24 h |
2 |
1 |
1 |
0 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
48 h |
3 |
1 |
1 |
0 |
2 |
1 |
3 |
1 |
3 |
1 |
2 |
1 |
72 h |
2 |
0 |
1 |
0 |
2 |
1 |
3 |
1 |
3 |
1 |
2 |
0 |
7 days |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
Mean value 24 + 48 + 72 h |
2.33 |
0.67 |
1.00 |
0.00 |
2.00 |
1.00 |
2.67 |
1.00 |
2.67 |
1.00 |
2.00 |
0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irrit. Cat 2 according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the skin irritation study the test substance caused slight to moderate skin irritation (mean erythema values over 24, 48 and 72 h: 2.33, 1.0, 2.0, 2.67, 2.67, 2.0; mean edema values over 24, 48 and 72 h: 0.67, 0.0, 1.0, 1.0, 1.0, 0.67), which was not fully reversible after 7 days. Thus the test subtance is considered as Skin Irrit. Cat. 2 (H315) according Regulation EC (no) 1272/2008
- Executive summary:
The skin irritation potential of the test substance was determined by an in vivo skin irritation test in rabbits according to OECD Guideline 404 and in compliance with GLP (1985). Treatment with test substance caused slight to moderate skin irritation (mean erythema values over 24, 48 and 72 h: 2.33, 1.0, 2.0, 2.67, 2.67, 2.0; mean edema values over 24, 48 and 72 h: 0.67, 0.0, 1.0, 1.0, 1.0, 0.67), which was not fully reversible after 7 days. Therefore, the test substance is considered to possess an irritant potential.
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