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Toxicological information

Skin irritation / corrosion

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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:
1994
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:
2002
Bibliographic source:
Crit. Rev. Toxicol. 32(6):551-626

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
yes
Remarks:
occlusive application of test material
Qualifier:
according to
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:
other: EPA Pesticide Assessment Guidelines, Section 81-5 (1984)
Deviations:
no
Qualifier:
according to
Guideline:
other: MAFF Primary Dermal Irritation Study (1985)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Dowicide 1 Antimicrobial, o-phenylphenol
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: MM931220

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
mean
Remarks:
of 6 animals
Time point:
other: 24+48+72 h
Score:
2.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24+48+72 h
Score:
1.3
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.