Registration Dossier
Registration Dossier
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EC number: 252-488-1 | CAS number: 35285-69-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 4-propoxycarbonylphenoxide
- EC Number:
- 252-488-1
- EC Name:
- Sodium 4-propoxycarbonylphenoxide
- Cas Number:
- 35285-69-9
- Molecular formula:
- C10H12O3.Na
- IUPAC Name:
- propyl 4-hydroxybenzoate
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated sites of the same animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
reading time points: 1, 24, 48, 72 h and 7 d - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Dermal application of the test substance did result in slight erythema in only one of three animals and no edema in any of the animals tested at any observation time point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- When evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin the test material was found to be not irritating.
- Executive summary:
The test item was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Dermal application of the test substance did result in slight erythema (fully reversible within 7 days) in only one of three animals and no edema in any of the animals tested at any observation time point.
With reference the reported effect in one of three animals and its reversibility the test substance does not need to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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