Pent-1-ene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16.07.1982 - 06.08.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Fully documented, non GLP Study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The stepwise approach from the guideline is not adopted. Only the average weight of the test animals is given, and not the weight at the beginning and end of the test.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pent-1-ene

EC Number:

203-694-5

EC Name:

Pent-1-ene

Cas Number:

109-67-1

Molecular formula:

C5H10

IUPAC Name:

pent-1-ene

Details on test material:

- Name of test material (as cited in study report): Pentene-1
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: not reported
- Weight: 2.6 - 2.9 kg
- Housing: single
- Diet (e.g. ad libitum): Standardized feed for test animals ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

The lids were gently held together for about one second in order to prevent loss of the material. No further indication on the exposure time was reported

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3 Female animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure:

SCORING SYSTEM:
Eye changes were scored according to standard method (EU B.5.). The scores were multiplied, averaged and added according to a predefined scheme resulting in an irritation index (Draize, J.H., Woodward, G. and H.O.Calvery, J. Pharmacol. Exp. Therap., 82, 377-390, 1944 and Draize, J.H. in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics; 46-59, Assoc. of Food and Drug Officials of the United States, Topeka, Kansas (1965)):
0-10 not irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 strongly irritating


TOOL USED TO ASSESS SCORE: hand-slit lamp (model: ophthalmoskop, Fa. Heine, Type med. 261)

Results and discussion

In vivo

Irritant / corrosive response data:

Only short-term changes of low intensity were induced upon insertion of 1-pentene into the rabbit eye. Cornea and Iris were without reaction upon contact. The conjunctiva reacted with redness, swelling and secretion. Redness consisted of the formation of slight hyperemia with a grade of 1. They appeared for all 3 animals up to 72 h. One animal showed a slight swelling which had disappeared after 48 h. Secretion was only observed for 2 animals. This finding was observed only for 1 hour after application. The intensity reached a grade of 2.

Other effects:

Systemic toxicity effects were not observed.

Any other information on results incl. tables

Effects of 1 -pentene on the conjunctiva of rabbit eyes (values for cornea and iris were 0 in all cases)

	exposition time (h)	reaction grade according to Draize   animal No.
		1	2	3
redness	1	1	1	1
	24	1	1	1
	48	1	1	1
	72	1	1	1
swelling	1	0	1	0
	24	0	1	0
	48	0	0	0
	72	0	0	0
secretion	1	1	2	0
	24	0	0	0
	48	0	0	0
	72	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The calculated irritation index reached a value of 2.8. Hence, 1-pentene is not irritating for the eye.

Executive summary:

For the determination of its effect on rabbit eyes, 1 -Penten was inserted into the conjunctival sac of rabbit eyes. It was applied in doses of 0.1 ml per eye. Only the conjunctiva showed low-grade changes.

The conjunctiva reacted short-term (after 1 hour) with redness, swelling and secretion. 48 h after application only slight hyperamia was observed which was declining immediately after the 72h-observation phase.

The obtained irritation score was 2.8.

1 -Pentene possesses no irritating effect on the mucous membrane of the eye.

Systemic toxicity effects were not observed.