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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: GLP study performed in manner consistent with OECD & EPA guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Adult test animals (all females) were received from Myrtle's Rabbitry, Tennessee, and weighed 2.1 to 2.5 kg. A five day quarantine was imposed prior to test initiation. Animals were maintained in room at 68-72 degrees F with 38-48% humidity, 12 hr light/12hr dark photocycle. Rabbits were fed Purina Rabbit Chow ad libitum, and provided drinking water ad libitum tested for chemical contaminants.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
The test material was applied to one site per animal in 0.5 gram amounts under a 1-inch square patch of moistened (with 0.5 ml water) gauze. Neck collars were affixed to prevent animals' interference with dermal test sites. These collars were in place for the full 72 hr test period.
Duration of treatment / exposure:
Gauze patches remained at test sites for period of 4 hrs. At that time, excess test material was removed by swabbing each site with moistened gauze.
Observation period:
Observations at chemical application sites at 1, 24, 48, & 72 hr after patch removal from dermal sites.
Number of animals:
Six females were used as test animals.
Details on study design:
Test chemical was applied to the dorsal area of the animal, one site (1-inch square) per rabbit. The binding was an elastic wrap covering the gauze patch.

The scoring system used was based upon Draize method. Animals were observed for clinical signs of intoxication.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hr period
Score:
ca. 0.23
Max. score:
0.37
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr period
Score:
ca. 0.46
Max. score:
0.75
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr period
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight erythema (score of 1 out of 4) seen in 5 of 6 rabbits.

Any other information on results incl. tables

No animals exhibited edema during 72 hr study.

Slight erythema (grade 1 of 4) was observed in 5/6 rabbits at 1 hr, 3/6 at 24 & 48 hrs, and 0/6 at 72 hrs.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Primary Irritation Index
Conclusions:
According to criteria established for Primary Irritation Index, the chemical is rated "slight irritant".
Executive summary:

The test chemical was subjected to a dermal irritation assessment consistent with methods described by OECD and EPA. Following application of undissolved test chemical to rabbit skin sites for a period of 4 hrs, scoring for signs of irritation were made at 1, 24, 48, & 72 hrs following removal of residual chemical. Only signs of slight erythema were observed. According to criteria established for Primary Irritation Index, the chemical is rated "slight irritant".