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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:
1991
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:
2006
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

Constituent 1
Chemical structure
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

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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