3,5-diethyl-1,2-dihydro-1-phenyl-2-propylpyridine

Eye irritation

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Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Version / remarks:

according to 40 CFR Part 792

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Purity 90%, Dark Yellow Liquid, Lot 31018BC

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

4 males and 2 females
Adult rabbits received from Davidson's Mill Farm, South Brunswick, NJ
All animals were housed singly in suspended stainless steel caging with mesh floors which conform to size recommendations.
Litter paper was placed beneath the cage and was changed at least three time per week.
Room temperature was kept at 68-70oF
12 hour light/dark cycles
Acclimation period of 14 days

Animals were given pelleted Purina Rabbit Chow and Filtered Water was supplied ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

One-tenth of a millileter

Duration of treatment / exposure:

One eye of each rabbit received the test substance and was applied to the eye for 1 second before releasing

Observation period (in vivo):

Animals were observed for 7 days for signs of eye irritation

Number of animals or in vitro replicates:

6

Details on study design:

6 rabbits recieved one-tenth of a millilter of the test substance instilled into the conjunctival sac of the right eye by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about 1 second before releasing, to prevent loss of the test substance. The other eye of each rabbit remained untreated to serve as a control. Elizabethan collars were placed on each rabbit and they were returned to their cages. Ocular irritation was evaluated using a high-intensity white light at 1,24, 48, and 72 hours and 4 and 7 days post instillation. Twenty four hours after instillation, collars were removed. The animals were observed for signs of toxicity, behavioral changes, and mortality at least once daily during the test period.

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

Mildly irritating to eyes

Any other information on results incl. tables

Results: Eye Irritation,

Wnorowski, 1994

Time:	Incidence of Irritation
Hours	Corneal Opacity	Iritis	Conjunctival Irritation
1	0/6	2/6	5/6
24	0/6	1/6	6/6
48	0/6	1/6	6/6
72	0/6	1/6	6/6
Days
4	0/6	1/6	6/6
7	0/6	0/6	0/6

Mean Scores per Timepoint

MMTS (Draize)

Time:	MMTS
Hours	5544	5545	5546	5547	5548	5549	Mean MMTS
1	17	12	15	10	8	10	12
24	12	8	17	12	14	14	12.8
48	6	4	17	8	10	8	8.8
72	8	4	17	8	10	6	8.8
Days
4	8	4	17	8	10	6	8.8
7	0	0	0	0	0	0	0

According toKay and Calandra,J. Soc. Cos. Chem. 13: 281-289, 1962)

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

The test material was tested in a study for eye irritation in vivo. Mild conjunctivitis was observed in all animals through day 4, and mild iritis was observed in 2 of 6 animals through day 4. The substance is classified as mildly irritating to the eye.