Registration Dossier
Registration Dossier
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EC number: 217-285-4 | CAS number: 1798-60-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable Draize Test, GLP was not compulsory at the time the study was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Principles of method if other than guideline:
- In test was according to the method of Draize (Fed. Reg. 38, No. 187, Para. 1500.41, S. 27019, 1973-09-27)
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted
Test material
- Reference substance name:
- (R)-1-hydroxy-1-phenylacetone
- EC Number:
- 217-285-4
- EC Name:
- (R)-1-hydroxy-1-phenylacetone
- Cas Number:
- 1798-60-3
- Molecular formula:
- C9H10O2
- IUPAC Name:
- (1R)-1-hydroxy-1-phenylpropan-2-one
- Details on test material:
- - Name of test material: (-)-Phenylacetylcarbinol
- Physical state: liquid
- Analytical purity: 67.4 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, 6050 Offenbach/ Main
- Weight at study initiation: 2.53- 3.22 kg
- Housing: single housing in steel cages, cage area: 40 x 51 cm
- Diet: Ovator Solikanin (Muskator-Werke, 4000 Duesseldorf, Germany), 130 g /day/animal
- Water: 250 mL/ day/ animal
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 26
- Humidity (%): 50- 80
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 8 days
- Number of animals:
- 4 males and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: length of wrap 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: no washing
SCORING SYSTEM:
-Reading time points: 24, 48, 72 hrs, 8 days
- Scoring of skin reaction: according toDraize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 2.72
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 2.06
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Other effects:
- After 8 days scale formation was seen, which was confirmed microscopically.
Any other information on results incl. tables
Table 1. Results of skin irritation study (only non-abraded skin)
Observation time |
Rabbit no. |
||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
||||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
24 h |
3 |
2 |
3 |
2 |
3 |
3 |
3 |
1 |
3 |
3 |
3 |
3 |
|
48 h |
3 |
2 |
3 |
3 |
3 |
2 |
1 |
0 |
3 |
3 |
3 |
3 |
|
72 h |
2 |
2 |
3 |
2 |
3 |
2 |
1 |
0 |
3 |
2 |
3 |
2 |
|
8 d |
2 |
1 |
3 |
2 |
3 |
2 |
0 |
0 |
2 |
0 |
3 |
1 |
|
Mean value 24 + 48 + 72 h |
2.67 |
2.00 |
3.00 |
2.33 |
3.00 |
2.33 |
1.67 |
0.33 |
3.00 |
2.67 |
3.00 |
2.67 |
|
Mean value 24 + 48 + 72 h all animals |
2.72 |
2.06 |
|
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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