Registration Dossier
Registration Dossier
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EC number: 603-758-6 | CAS number: 133647-88-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991-07-30 to 1991-08-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study on structural analogue (free acid) according to guideline: EEC Directive 84/449/EEC Method B.4. The fact that the study is used for read-across purposes triggers reliability rating 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation terminated after 72 hours (no observable effects)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- IUPAC Name:
- (R)-2-(4-Hydroxyphenoxy)propanoic acid
- Reference substance name:
- (R)-2-(4-hydroxyphenoxy)propanoic acid
- EC Number:
- 407-960-3
- EC Name:
- (R)-2-(4-hydroxyphenoxy)propanoic acid
- IUPAC Name:
- 407-960-3
- Reference substance name:
- Propanoic acid, 2-(4-hydroxyphenoxy)-, (2R)-
- IUPAC Name:
- Propanoic acid, 2-(4-hydroxyphenoxy)-, (2R)-
- Reference substance name:
- 94050-90-5
- Cas Number:
- 94050-90-5
- IUPAC Name:
- 94050-90-5
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance type: pure test substance
- Physical state: off-white / gray powder
- Expiration date of the lot/batch: 1992-01-15
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: individually in metal cages with perforated floors
- Diet: SDS Stanrab (P) Rabbit Diet ad libitum
- Water: ad libitum
- Acclimation period: yes, duration not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 1991-07-30 To: 1991-08-02
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- distilled
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
washing with water after removal of the semiocclusive dressing and gauze - Observation period:
- 30 min after removal of dressings, 24, 48, and 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square, approximately 6cm2
- Type of wrap if used: gauze pad (moistened with 0.5 mL distilled water), Elastoplast elastic adhesive dressing, semiocclusive
- Animals not restrained
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, to remove any residual test substance
- Time after start of exposure: 4 hours
SCORING SYSTEM:
-According to EU Method B.4, Table 1: Grading of Skin Reactions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of edema at any time, reversibility could therefore not be assessed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of edema at any time, reversibility could therefore not be assessed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of edema at any time, reversibility could therefore not be assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of eryhtema at any time, reversibility could therefore not be assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of eryhtema at any time, reversibility could therefore not be assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of eryhtema at any time, reversibility could therefore not be assessed
- Irritant / corrosive response data:
- No dermal response to treatment in any animal at any time point
- Other effects:
- No signs of toxicity or ill health throughout the observation period
Any other information on results incl. tables
No signs of skin irritation were observed with the source substance, the free acid (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5), which has pH 1.8 in concentrated aqueous solution, in any animal at any time.
The skin irritation potential of the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) (CAS 133647-88-8) is determined by read-across from the test with the free acid. The analogue approach is based on the facts that source and target contain the identical molecular structure and the same functional groups (except the Na+ counterion), and that the Na+ salt is expected to have a next-to-neutral pH, below 8.5. The additional amount of sodium applied to the skin is not expected to permeate the skin due to its ionic nature, therefore it is not taken up and will not elicit systemic adverse effects.
As a conclusion, propanoic acid, 2-(4-hydroxyphenoxy)-, sodium salt (2R) is not expected to be a skin irritant.Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium (2R)-2-(4-hydroxyphenoxy)propanoate is not expected to be a skin irritant derived from read-across.
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