Registration Dossier
Registration Dossier
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EC number: 203-956-9 | CAS number: 112-30-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decan-1-ol
- EC Number:
- 203-956-9
- EC Name:
- Decan-1-ol
- Cas Number:
- 112-30-1
- Molecular formula:
- C10H22O
- IUPAC Name:
- decan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc., Clemmons, NC
- Age at study initiation: young adults
- Housing: individually suspended stainless steel caging with mesh floors
- Diet: Purina rabbit chow, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 55-83
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The individual dose sites were scored at ca. 30-60 minutes, 24,48 and 72 hours and at 7 and 10 days after patch removal.
- Number of animals:
- 3F
- Details on study design:
- TEST SITE
- Area of exposure: the back
- Type of wrap if used: The pad and the entire trunk of each animal were wrapped with semi-occlusive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):the test sites were gently cleansed with acetone, ethanol and a 3% soap solution followed by tap water using a clean paper towel to remove any residual test substance
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other:
- Time point:
- other: PDI for 30-60 minutes,24,48 and 72 hours/4
- Score:
- 2.8
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- For the first 24 hours after patch removal, all three treated sites exhibited well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased gradually with time. All animals were free of dermal irritation by day 10 (study termination).
- Other effects:
- All animals appeared active and healthy during the study. Apart from the dermal irritation noted, there were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Remarks:
- Not classified according to Regulation (EC) No 1272/2008
- Conclusions:
- The in vivo skin irritation study for decan-1-ol, conducted according to a protocol similar to OECD Test Guideline 404 and in compliance with GLP, concluded decan-1-ol to be mildly irritating to skin, but not sufficient for classification.
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