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EC number: 212-429-2 | CAS number: 816-19-3
- 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 2-ethylhexanoate
- EC Number:
- 212-429-2
- EC Name:
- Methyl 2-ethylhexanoate
- Cas Number:
- 816-19-3
- Molecular formula:
- C9H18O2
- IUPAC Name:
- methyl 2-ethylhexanoate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: Room temperature.
- 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 supplier
- Age at study initiation: Young adult
- Weight at study initiation: Not reported.
- Housing: individually housed in labeled cages with mesh floors conform to the size recommendations in the most recent Guide for the Care
and Use of Laboratory Animals DHEW (NIH)
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): Not reported.
- Air changes (per hr):Not reported.
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
IN-LIFE DATES: From: 01/10/03 To: 15/10/03
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 test material - Duration of treatment / exposure:
- 4 hours ( test sites were gently cleaned of any residual test substance).
- Observation period:
- Individual dose sites were scored at approximately 1, 24, 48 and 72 hours and at 7, 10 and 14 days after patch removal.
- Number of animals:
- 3; all females
- Details on study design:
- TEST SITE
- Area of exposure: applied to one 6 cm2 intact dose site on each animal
- % coverage: not reported
- Type of wrap if used: semi-occlusive 3 inch Micropore tape
SCORING SYSTEM: Draize scoring system; the classification of irritancy was obtained by adding the average erythema and edema scores for the
1, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals and calculation of the resulting Primary Dermal Irritation Index (PDll).
1. Evaluation of Skin Reactions
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
Edema formation:
No edema - 0
Very slight edema (barely perceptible) - 1
Slight edema (edges of area well defined by definite raising) - 2
Moderate edema (raised approximately 1 millimeter) - 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) - 4
Primary Dermal Irritation Index (PDll)
PDII / Classification
0 / Non-irritating
> 0-2.0 / Slightly irritating
2.1-5.0 / Moderately irritating
>5.0 / Severely irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 10 days
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 10 days
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 4.5
- Remarks on result:
- other: 1, 24, 48, and 72 hour evaluation; 4 evaluation intervals
- Irritant / corrosive response data:
- Individual skin irritation scores are presented. A summary of primary skin irritation scores used for calculation of Primary Dermal Irritation Index is presented. Within 24 hours of patch removal, all three treated sites exhibited severe erythema and very slight edema. Desquamation was noted for two animals between Days 10 and 14. Although the overall severity of irritation decreased gradually by the end of the study, irritation persisted for all animals through Day 14 (study termination).
- Other effects:
- All animals appeared active and healthy. Apart from the dermal irritation, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- Under the conditions of the study the test substance is considered to be moderately irritating to skin.
- Executive summary:
The study was performed to US EPA OPPTS 870.2500 and OECD 405 to assess the primary skin irritancy potential of the test substance in accordance with GLP. Five-tenths of a milliliter of the test substance was applied to one 6 cm2 intact dose site on each animal and covered with a 1 inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 inch Micropore tape to avoid dislocation of the pad. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleaned of any residual test substance. Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48, and 72 hours and at 7, 10, and 14 days after patch removal. The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals. Within 24 hours of patch removal, all three treated sites exhibited severe erythema and very slight edema. Desquamation was noted for two animals between Days 10 and 14. Although the overall severity of irritation decreased gradually by the end of the study, irritation persisted for all animals through Day 14 (study termination). The Primary Dermal Irritation Index for the test substance is 4.5. Under the conditions of this study the substance is classified as moderately irritating to the skin.
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