Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25.7.1985 - 3.9.1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA. Office of pesticides and Toxic Substances, Office of Toxic Substances (TS-792). Primary dermal irritation. In: Health effects test guidelines. Washigton, DC: EPA, August 1982, EPA 560/6-82-001
Deviations:
yes
Remarks:
See Overall remarks
Qualifier:
according to
Guideline:
other: Primary dermal irritation study. LAIR Standard Operating Procedure OP-STX-34. Presidio of San Francisco, CA: Letterman Army institute of Research, 19 March 1982
Deviations:
yes
Remarks:
See Overall remarks
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylene Glycol Dinitrate (DEGDN)
- The DEGDN was shipped containing 18% acetone (a desensitizer).
- Analytical purity: 96.6.%
- Impurities (identity and concentrations): The impurities were not identified.
- Lot/batch No.: RAD84MOO1S214
- Stability under test conditions: stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA 95076
- Age at study initiation: Young Adults
- Weight at study initiation: 3.0 - 3.6. kg
- Housing: individually in stainless steel, battery-type cages with screened floors and automatically flushing dumptanks.
- Diet (e.g. ad libitum): 150 g/day of Certified Purina Chow Diet 5322 (Ralston Purina Company, St Louis, MO
- Water (e.g. ad libitum): continuous drip from a central line
- Acclimation period: 15 days ???

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 20°C
- Humidity relative (%): 42 - 60%, with occasional spikes to 35% during room cleaning
- Photoperiod (hrs dark / hrs light): 12 hours of light per day

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
- Preparation: The DEGDN was received as a solution containing 18% acetone. The acetone was removed by evaporation before study.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the patches
Number of animals:
Six males and two females were assigned to study. One female was submitted for quality necropsy during quarantine. One male was sacrificed due to traumatic ulcerative pododermatitis before start dosing.
The remaining six animals - 5 males and 1 female were dosed.
Details on study design:
TEST SITE
- The shaved backs of rabbits were divided into four quadrants. Two sites were treated with the test compound. One site was a sham control (no treatment) and one site was a sham gauze patch control.
- Area of exposure: 1-inch square
- Type of wrap if used: Blenderm, a semiimpervious hypoallergenic surgical tape, was used to hold the patches in place. Vetrap was then wrapped securely around the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was gently wiped if the test material adhered to it.
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Topically apllied DEGDN produced neither edema nor erytheme at any test site on six rabbits. Also, all sham sites were negative for dermal reactions.
The six dosed animals were submitted for gross necropsy. There were no signs of skin irritation in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DEGDN should be classified as anonirritant since it causes no grossly detectable dermal reactions under conditions of this study.