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EC number: 201-993-5 | CAS number: 90-43-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- secondary source
- Title:
- O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment
- Author:
- Bomhard, E. M. et al.
- Year:
- 2 002
- Bibliographic source:
- Crit. Rev. Toxicol. 32(6):551-626
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- yes
- Remarks:
- occlusive application of test material
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1988)
- Deviations:
- yes
- Remarks:
- occlusive application of test material
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Section 81-5 (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Primary Dermal Irritation Study (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Biphenyl-2-ol
- EC Number:
- 201-993-5
- EC Name:
- Biphenyl-2-ol
- Cas Number:
- 90-43-7
- Molecular formula:
- C12H10O
- IUPAC Name:
- [1,1'-biphenyl]-2-ol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Dowicide 1 Antimicrobial, o-phenylphenol
- Lot/batch No.: MM931220
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, MI
- Age at study initiation: 16 weeks (animals were born on 6 Nov 1993 and dosed on 22 Feb 1994)
- Weight at study initiation: 2.12-2.52 kg
- Fasting period before study: no
- Housing: individually
- Diet: Purina Certified Rabbit Chow #5322 (Purina Mills Inc., St. Louis, MO), 4 oz/day (=113,398 g/day)
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±3
- Humidity (%): 40-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 Feb 1994 To: 8 Mar 1994
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.3 mL
- Purity: distilled - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 per sex
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: elastic rabbit jacket
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with damp disposable towel
- 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 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Very slight erythema was observed at the application site of 1/6 rabbits within 30 minutes and on 2/6 animals 24 hours after test material removal. Severe to slight eschar formation was observed on 4/6 rabbits within 30 minutes of test material removal and persisted through the remainder of the study. 4/6 animals had burns at the application site within 30 minutes of test substance removal. The burns resolved as scabs and then scars by study termination.
4/6 rabbits had very slight to severe oedema 30 minutes and 24 hours after test material removal. Slight to severe oedema was observed on 3/6 animals 48 and 72 h after removal of the test substance. - Other effects:
- There were no effects on body weights noted throughout the study period.
Any other information on results incl. tables
Table 1: Individual Rabbit Skin Irritation Grades
Observation time following patch removal |
Animal |
Erythema |
Oedema |
Within 30 min |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
4 a |
4 |
|
4 |
4 a |
1 |
|
5 |
4 a |
1 |
|
6 |
4 a |
2 |
|
24 h |
1 |
1 |
0 |
2 |
1 |
0 |
|
3 |
4 a |
4 |
|
4 |
4 a |
1 |
|
5 |
4 a |
1 |
|
6 |
4 a |
2 |
|
48 h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 a |
4 |
|
4 |
4 a |
2 |
|
5 |
4 a |
0 |
|
6 |
4 a |
2 |
|
72 h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 a |
4 |
|
4 |
4 a |
2 |
|
5 |
4 a |
0 |
|
6 |
4 a |
2 |
|
Day 7 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 b |
0 |
|
4 |
4 b |
0 |
|
5 |
4 b |
0 |
|
6 |
4 b |
0 |
|
Day 8 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 b |
0 |
|
4 |
4 b |
0 |
|
5 |
4 b |
0 |
|
6 |
4 b |
0 |
|
Day 9 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 b |
0 |
|
4 |
4 b |
0 |
|
5 |
4 b |
0 |
|
6 |
4 b |
0 |
|
Day 10 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 b |
0 |
|
4 |
4 b |
0 |
|
5 |
4 b |
0 |
|
6 |
4 b |
0 |
|
Day 11 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 c |
0 |
|
4 |
4 c |
0 |
|
5 |
4 c |
0 |
|
6 |
4 c |
0 |
|
Day 14 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 d |
0 |
|
4 |
4 d |
0 |
|
5 |
4 d |
0 |
|
6 |
4 c |
0 |
|
Day 15 |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
4 d |
0 |
|
4 |
4 d |
0 |
|
5 |
4 d |
0 |
|
6 |
4 d |
0 |
a = burns at application site; b = scabs at application site; c = scabs and scars at application site; d = scars at application site
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The scores derived from this study indicate that the test item was corrosive to the rabbits' skin. However, the test was conducted under occlusive conditions, which is not in line with current guideline requirements and is considered to be more rigorous compared to the semi-occlusive patching used today. Thus, as recommended by ECHA (2012), having regard to the method of application, the test item is considered to be highly irritating.
Reference:
ECHA. (2012a). Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. Version 3.0, November 2012.
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