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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: 40CFR Section 163.81-5, Federal Register, August 22, 1978 and subsequently modified in accordance with the revised EPA pesticide Assessment Guidelines of November 1982.
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:
TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglassville, PA 19518.
- Housing: Stainless steel cages with elevated wire mesh flooring, 1 rabbit/cage.

- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-75F.
- Humidity (%):55% +/- 25.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

IN-LIFE DATES: 19 August 1986 to 02 September 1986.

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
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
The test substance was administered once per site and remained in contact with the skin for 4 hours followed by removal with white mineral oil.
Observation period:
The skin was examined and graded for dermal reaction within 30-60 minutes following patch removal. Readings were also made after 24, 48 and 72 hours and on days 7 and 14
Number of animals:
Six rabbits
Details on study design:
TEST SITE
- Approximately 24 hours prior to application, the hair was clipped from the backs of the rabbits. Each animal received a 0.5 ml dose applied to the test site. Gauze patches were placed over the treated and control areas which were held in place with non-irritating tape. A suitable semi-occlusive dressing was wrapped around the trunks of the animals to hold the patches in place. Following the exposure period, the test sites were wiped with white oil.
SCORING SYSTEM: : Dermal Irritation was graded in accordance with the Draize method of scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24. 48 and 72 hours
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.7
Max. score:
8
Reversibility:
no data
Remarks:
not applicable
Irritant / corrosive response data:
The test article produced mild skin irritation in albino rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the results of this study, the test substance would not be classified as a non- irritant in accordance with the classification system of GHS.
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. A single 0.5 ml dose of the test material was applied to a single site on each animal's back.Alldoses were applied under semi-occlusive dressing for a four hour exposure period. At completion of exposure the bandages were removed and the sites washed with white. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes following patch removal.were also made after 24, 48 and 72 hours and on days 7 and 14.

ThePrimary Irritation Index was calculated to be 1.7 for sites treated with the test material.

Based on the results of this study, the test substance is not an irritant in accordance with the classification system of GHS.