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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with full report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Life Science Research Ltd

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Perkadox BC (Dicumylperoxide)
- Substance type: organic
- Physical state: white crystalline powder
- Analytical purity: 99.61%
- Impurities (identity and concentrations): not specified
- Purity test date: 09.06.1992
- Lot/batch No.: 041920580858
- Storage condition of test material: in refrigerator
- Other: certifcate of analysis attached in report

In vitro test system

Test system:
other: in vivo testing

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: 3.5 to 4 months
- Weight at study initiation: 2.9 to 3.12 kg
- Housing: individually
- Diet: standard pelleted rabbit diet (SQC Rabbit Diet, Special Diets Services Ltd), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: not specified (based on infromation in report assumed to be more than a week)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 45-56%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6x6 cm
- Type of wrap if used: unmedicated gauze (3x2cm), held in place on the left site by strips of blenderm; right site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: after 4h


SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean 24, 48, 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean 24, 48, 72h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
See table below.

Any other information on results incl. tables

 

 

 

 

Response

 

Time of observation

Rabbit No.

 

 

1

2

3

Erythema

 

 

 

 

 

1 h

0

1

1

 

24 h

0

1

1

 

48 h

0

1

0

 

72 h

0

0

0

Edema

 

 

 

 

 

1 h

0

0

0

 

24 h

0

1

0

 

48 h

0

0

0

 

72 h

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the result of the study the substance was not irritating when tested on rabbit skin.
Executive summary:

Very slight erythema was observed in 2 rabbits during the first 24h follwing bandage removal, continuing in 1 rabbit at the 48 h examination. Very slight oedema was evident at the one test site at the 24 h obersavtion. The test site of both these rabbits was overtly normal at the 72 h examination.