Registration Dossier
Registration Dossier
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EC number: 212-222-7 | CAS number: 770-35-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in compliance with GLP regulations
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
- Reference Type:
- secondary source
- Title:
- SIDS for Propypelene Glycol Phenyl Ether - CAS No: 770-35-4 (major isomer - Secondary Alcohol), 4169-04-4 (minor isomer - Primary Alcohol), 41593-38-8 (commercial mixed isomer product). Oct 2006
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- SIDS Initial Assessment Report For - SIAM 18- Paris, France, 20-23 April 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-phenoxypropan-2-ol
- EC Number:
- 212-222-7
- EC Name:
- 1-phenoxypropan-2-ol
- Cas Number:
- 770-35-4
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 1-phenoxypropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Protectol PP
- Physical state: liquid, achromatic
- Analytical purity: mixture (86/14.9%)
- Composition of test material, percentage of components: 84.8% 1-phenoxy-propan-2-ol and 14.7% 2-phenoxy-propan-1-ol
- Lot/batch No.: P. 70-1840
- Stability under test conditions: verified by reanalysis
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Glauker ; D-6050 Offenbach/Main, FRG
- Age at study initiation: young adult
- Weight at study initiation: mean of 2.54 for the 2 males, 2.79 for the female
- Housing: singly in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm X 51 cm
- Diet: Kliba 341, 4MM; Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland; about 130 g per animal per day; ad libitum
- Water: about 250 ml tap water per animal per day; ad libitum
- Acclimation period: at least 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping of the fur was done at least 15 hours before the beginning of the study
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- The skin was examined for erythema and edema 30-60 min after removal of test patch, and at 24, 48 and 72 hrs after the start of the test.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm application site on the upper third of the back or flanks
- % coverage: no data
- Type of wrap if used: with a porous dressing (4 layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM: OECD
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: only one animal showed a positive response (score 1) directly after treatment, which was reversible within 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- based on the irritation scores, the test substance is not irritating according to the EU and to GHS
- Other effects:
- no other effects
Any other information on results incl. tables
-
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irritation was observed in any of the test animals after dermal application of phenoxpropanol. The mean scores for both erythema and edema were 0 at 24, 48 and 72 hours.
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