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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:
"In Life" dates 12th to 19th September 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study following GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
122384-85-4/68855-45-8
Phenol, tetrapropenyl-, sulfurized, calcium salts
Test material dosed as received, purity not provided.

Test animals

Species:
rabbit
Strain:
other: Hra:(NZW)SPF strain
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc., Kalamazoo, Michigan on September 4, 1996.
- Age at study initiation: approximately 13 weeks of age
- Weight at study initiation: weighing from 2,098 to 2,427 g
- Housing: the animals were individually housed in suspended stainless steel cages.
- Diet/water (e.g. ad libitum): The animals were provided access to water ad libitum and a measured amount of Laboratory Rabbit Diet HF #5326, PMI Feeds, Inc. The feed is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Samples of the water are periodically analyzed. There were no known contaminants in the feed or water at levels that could be expected to interfere with or affect the results of the study.
- Acclimation period: After receipt, the animals were acclimated for a period of at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 23 °C
- Humidity (%): 50% +20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark lighting cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): The undiluted test material was applied to the intact skin site on each animal's back (approximate exposure area of 6.25 cm2) in the amount of 0.5 mL.

Duration of treatment / exposure:
four hours
Observation period:
4, 24, 48, 72, 96 hours and 7 days.
Number of animals:
Three per sex per dose (male and female)
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: The area of application was covered with a 4-ply 2.5-cm x 2.5-cm gauze patch secured with two strips of Micropore surgical tape. The trunk of the animal was then loosely overwrapped with a sheet of perforated plastic film that was secured on both ends with strips of Elastoplast® tape to provide a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4-hour exposure period, the patches were removed and any remaining test material was removed from the test sites using mineral oil followed by liquid Ivory® soap mixed with warm tap water. The test sites were then rinsed with clean tap water and dried with disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. The area of control skin was treated in the same manner.

SCORING SYSTEM:
Thirty minutes after removal of the test material, the degree of erythema and edema at each test site was read according to the Draize technique (recorded as the 4-hour score). Subsequent examinations were made at 24, 48, 72, and 96 hours and Day 7. An area of untreated skin on each animal was used for comparison.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
2.8
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: The primary dermal irritation index (PDII) is the sum of the individual index scores, divided by the number of animals, and rounded to the nearest tenth.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
1.2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Application of the test material to the skin of rabbits under 4-hour semioccluded conditions resulted in very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation.

Any other information on results incl. tables

The average of the individual animal index scores is 2.8. The average of the 24-, 48-, and 72-hour scores are 1.2 for erythema and 1.3 for edema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation.
Executive summary:

In an acute dermal irritation study in the New Zealand White Rabbit conducted to OECD guideline 404 in accordance with GLP, the primary dermal irritation potential of the test material was evaluated in rabbits under 4-hour semi-occluded conditions. The test material produced very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation. The average of the individual index scores (the total of the erythema and edema scores at 4, 24, 48, and 72 hours divided by 4) is 2.8. The average of the 24-, 48-, and 72-hour scores are 1.2 for erythema and 1.3 for edema.

The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1.2 and so will not be classified as irritating according to the dangerous substances directive, 67/548/EEC.