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:

guideline study with acceptable restrictions

Remarks:

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

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Pentene-1

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

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animals 1-3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animals 1-3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

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

Table 7.3.2/1: 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:

GHS criteria not met

Conclusions:

Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an eye irritation study performed similarly to the EU Method B5, 0.1 mL of undiluted test material was instilled into one eye of 3 female Russian rabbits. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.

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.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea and iris scores; 1.0 / 1.0 / 1.0 for conjunctivae score and 0.0 / 0.3 / 0.0 for chemosis score.

Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.