Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22.8. - 24.9.1985
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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Primary Eye Irritation. In: Health effects test guidelines. Washington, DC: EPA, Aug 1982, EPA 560/6-82-001
Deviations:
yes
Remarks:
See Overall remarks
Qualifier:
according to
Guideline:
other: Primary Eye Irritation Study. LAIR Standard Operating Procedure OP-STX-33, Letterman Army Institute of Research, Presidio of San Francisco, CA. 15 June 1984
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): diethyleneglycol dinitrate (DEGDN)
- Physical state:pale yellow liquid
- Analytical purity: 96.6%
- Impurities (identity and concentrations): not identified
- Stability under test conditions: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA 95076
- Age at study initiation: Young Adults
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individual.y in stainless steel, battery-type cages with screened floors and automatically flushing dumptanks
- Diet (e.g. ad libitum): approximately 150 g/day of Certified Purina Chow Diet 5322 (Ralston Purina Company, Checkerboard Square, St. Louis, MO)
- Water (e.g. ad libitum): from central line
- Acclimation period: 5-12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 21.1°C
- Humidity (%): 44 - 58%
- Photoperiod (hrs dark / hrs light): 12 hours of light per day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
None - Due to an almost total lack of reaction during the 72 hours after dosing, the study was terminat(ed, according to protocol, after this observation. Therefore no scoring or observations were performed at 7, 14 or 21 days.
Number of animals or in vitro replicates:
6 animals
Details on study design:
SCORING SYSTEM: Adapted from Table 6 in Draize et al. (Draize JH, Woodlard G, Calvery HO. Methods for the study of irritation and toxicity of substances apllied topicalIly to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 1944; 82:377-390.)

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein (omitted from observations at 1 and 4 hours)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DEGDN did not produce sufficient irritation under conditions of this study to be classified as an ocular irritant.
Executive summary:

The potential for diethyleneglycol dinitrate (DEGDN) to produce primary eye irritation was evaluated in six male New Zealand White rabbits by using a modified Draize method. DEGDN produced no response indicative of a potential to cause irritation upon direct contact with the eye. Slight iridial vasodilation (one of six rabbits) and slight conjunctival vasodilation and swelling, indicative of mild inflammation, (three of six rabbits) were the most serious responses observed. DEGDN was classified as a non-irritant under conditions of this study.