Registration Dossier
Registration Dossier
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EC number: 201-089-0 | CAS number: 78-16-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Nov - 06 Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- September 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate
- EC Number:
- 201-089-0
- EC Name:
- 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate
- Cas Number:
- 78-16-0
- Molecular formula:
- C27H50O6
- IUPAC Name:
- 2,2-bis[(heptanoyloxy)methyl]butyl heptanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Analytical purity: approx. 100 %
- Storage condition of test material: at room temperature in the dark
- Specific gravity: 0.9 g/mL (25 °C)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 20 - 21 weeks
- Weight at study initiation: 3.1 kg ± 202.53 g
- Housing: individually in plastic cages with perforated floors
- Diet: 100 g / day, LK-01, Hope Farms, Woerden, The Netherlands
- Water: tap-water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 55 -65
- Air changes: air conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 100 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 50 min, 24, 48, 72 h - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap: gauze patch attached with a drop of petrolatum to aluminium foil and mounted on permeable tape, held in place with flexible bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: remaining test substance was removed, using a dry tissue and subsequently a tissue moistened with tap-water.
- 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 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Very slight erythema and edema were observed in all animals 24 h after treatment which were fully reversible latest within 72 h.
- Other effects:
- No signs of systemic toxicity were observed in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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