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EC number: 226-641-8 | CAS number: 5444-75-7
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl benzoate
- EC Number:
- 226-641-8
- EC Name:
- 2-ethylhexyl benzoate
- Cas Number:
- 5444-75-7
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 2-ethylhexyl benzoate
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexyl benzoate
- Physical state: clear colourless liquid
- Analytical purity: 99.734%
- Impurities (identity and concentrations): 2-Ethyl-4-methyl-1-pentyl benzoate 0.209%, C8 benzoate 0.023%, 2-Ethylhexyl phthalate 0.004%, unknown impurities 0.03%
- Lot/batch No.: 9915-133-2
- Expiration date of the lot/batch: 2000-12-04
- Storage condition of test material: room temperature in light, in brown glass bottle
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd. (Bicester, UK)
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.6-2.7 kg
- Housing: animals were housed individually in stainless steel cages with perforated floors.
- Diet: Special Diet Services STANRAB (P) SQC pellet, ad libitum. The animals were fed hay on arrival and subsequently three times a week.
- Water: drinking water, ad libitum
- Acclimation period: 8 days
- Other: During the acclimatisation and study period the animals were given small soft white untreated wood blocks for environmental enrichment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-24.5
- Humidity (%): < 20-35
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 20 min, 16, 43 and 72 h and daily through Day 14 - Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: The treatment site was covered with Elastoplast elastic adhesive dressing (patch).
REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed with warm water to remove any residual test substance and blotted dry with absorbent paper.
- 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:
- other: mean over 16, 43 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 16, 43 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 16, 43 and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: slight erythema were still apparent
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 16, 43 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Very slight to well defined erythema was seen in all animals (mean score over 16, 43 and 72 h out of all 3 animals: 0.67). In addition, thickening of the skin was observed in two animals. Reactions gradually reversed and had resolved completely in two animals by Day 8 or Day 13, respectively. However, very slight erythema was still evident in one animal at Day 14.
- Other effects:
- No signs of toxicity or ill health were observed in any animal during the study period.
Any other information on results incl. tables
Table 1. Results of skin irritation study.
Observation time |
Rabbit no. |
||||||
1 |
2 |
3 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
0.33 h |
0 |
0 |
0 |
0 |
1 |
1 |
|
16 h |
0 |
0 |
0 |
0 |
1 |
0 |
|
43 h |
0* |
0 |
1 |
0 |
1 |
0 |
|
72 h |
2* |
0 |
1 |
0 |
2* |
0 |
|
Mean value 16 + 43 + 72 h |
0.00 |
0.00 |
0.67 |
0.00 |
1.33 |
0.00 |
|
Mean value 16 + 43 + 72 h all animals |
0.67 |
0.00 |
|
|
|
|
|
*: Thickening of the skin |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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