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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
STUDY INITIATED ON April 29,1999 STUDY COMPLETED ON August 16,1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
61789-86-4
IUPAC Name:
61789-86-4
Constituent 2
Reference substance name:
Sulfonic acids, petroleum, calcium salts
EC Number:
263-093-9
EC Name:
Sulfonic acids, petroleum, calcium salts
IUPAC Name:
263-093-9
Details on test material:
Identification: OS65841C
Lot Number: None provided
Source: The Lubrizol Corporation, 29400 Lakeland Boulevard, Wickliffe, OH 44092-2298
Date Received: April 28, 1999
Purity: Test article purity data are the responsibility of thesponsor
Stability: Test article stability data are the responsibility of the sponsor
Physical Description: Dark brown, viscous liquid
Storage Conditions: Original container at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source: Covance Research Products, Inc., Denver, PA

Number: Three males and three females

Body Weight Range: 2370 to 3328 grams at initiation of dosing
Age at Start of Study: Young adult
Method of Identification: Eartag

Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in
accordance with standard operating procedures.

Acclimation: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

Food and Water: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150 g per day during the study. Analysis of feed was performed and provided by the manufacturer. Reverse osmosis-treated municipal water was provided ad libitum. Water was analyzed in accordance with standard operating procedures. Contaminants were not present in animal feed or water at levels expected to interfere with the objective of this study. Results of analyses are available upon sponsor request.
Environmental Conditions: Animal room with controlled temperature (64.1- 67.2°F), humidity (50.1-76.7%) and light (12 hours light/l2 hours dark). The humidity was slightly above the protocol-specified range (30-70%) within the study period. A brief period of slightly increased humidity would not be expected to adversely affect the health of the rabbits. Therefore, this deviation did not affect the quality or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The dosage level was 0.5 ml/site.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Test Article Preparation:
Prior to use, the original container of the test article was agitated to insure a homogeneous mixture. A sufficient amount of test article was dispensed and a stir bar was added. The test article was stirred continuously throughout use.

Route and Rationale of Test Article Administration:
The route of administration for the test article was direct application to clipped, unabraded skin. This route of administration is standard for assessment of local dermal irritative potential.

Method of Test Article Administration:
On the day prior to dosing, the hair was removed from the backs and flanks of the rabbits using an electric clipper. Each 0.5-ml dose was applied to an area of skin approximately 2.5 x 2.5 cm under a two-ply gauze patch secured in place with Micropore tape. The patches were overwrapped with a gauze binder and secured with Dermiform tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article andor bandages.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other:
Basis:
animal: 28361 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 13 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Yellow staining at test site at 1 and 24 hours.
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 28364 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 13 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Yellow staining at test site at 1 and 24 hours. Desquamation at 7 - 13 days
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 28466 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Yellow staining at test site at 1, 24 and 48 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28474 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Remarks on result:
other: Yellow staining at test site at 1, 24, 48 and 72 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28749 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Yellow staining at test site at 1, 24 and 48 hours
Irritation parameter:
other: Erythema/Eschar
Basis:
animal: 28482 female
Time point:
other: Highest score at 1, 24, 48, 72 hours and 4 - 8 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Yellow staining at test sites at 1, 24 and 48 hours
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28361 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours and 4 - 13 days
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28364 male
Time point:
other: Highest score at 24, 48 and 72 hour, 4 - 13 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
other: Oedema Formation
Basis:
animal: 28466 male
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28474 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28749 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritation parameter:
other: Oedema formation
Basis:
animal: 28482 female
Time point:
other: Highest score at 1, 24, 48 and 72 hours, 4 - 8 days
Score:
0
Max. score:
4
Reversibility:
other: no evidence of skin irritation
Irritant / corrosive response data:
Mortality:
There were no deaths during the study.

Dermal Observations (Table 1 - attachment 1):
The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively.There were no other signs of dermal irritation noted during the study. All dermal irritation completely subsided by day 13.

Body Weiphts (Table 2 - attachment 2):
There were no remarkable body weight changes during the study period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information The test article, OS65841C, received a descriptive rating classification of slightly irritating. Criteria used for interpretation of results: other: Draize JH 1965
Conclusions:
There were no deaths or remarkable body weight changes during the study period.
The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively. There were no other signs of dermal imtation noted during the study. All dermal imtation completely subsided by day 13.
The Primary Irritation Index was calculated to be 0.5. The test article, OS65841C, received a descriptive rating classification of slightly irritating.
Executive summary:

The primary dermal irritation potential of OS65841C was evaluated in this study with New Zealand White rabbits.

There was one group of six albino rabbits that received a single, four-hour, semioccluded exposure.

Each 0.5-ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed.

Application sites were evaluated in accordance with the method of Draize (attachment 3) at approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and daily through day 13, if irritation persisted.

The test article induced very slight to slight erythema and very slight edema on five and one animals, respectively. Desquamation and yellow staining of the skin were noted for one and six rats, respectively. There were no other signs of dermal irritation noted during the study. All dermal irritation completely subsided by day 13.

The test article, OS65841C, received a descriptive rating classification of slightly irritating.