Pent-1-ene

Endpoint summary

Description of key information

Skin irritation: Not irritating (EU Method B4, Rel.2, K).

Eye irritation: Not irritating (EU Mehod B5, Rel. 2, K).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.7.1982-26.7.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Fully documented, non GLP Study.

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No stepwise approach was adopted. Only the average weight of the test animals is given, and not the weight at the beginning and end of the test.

Principles of method if other than guideline:

In addition to the stated guideline, the test substance was applied to damaged skin to investigate systemic effects.

GLP compliance:

no

Species:

rabbit

Strain:

other: Russian (Albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 10 - 11 months
- Weight: 2.7 - 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
- gender: female

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

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

Observation after 1, 24, 48 and 72 hours

Number of animals:

3 female animals tested

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: 6.25cm2 linen piece, covered by a synthetic self-adhesive strip; subsequently the patches were covered by a bandage (acrylastic)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Values for erythema and eschar formation as well as oedema formation were averaged for all animals and summed up. The sum resulted from 16 averages and was divided by 8 to obtain the primary irritation index:
0.0 - 0.5: non irritating
0.6 - 3.0: slightly irritating
3.1 - 5.0: moderately irritating
5.1 - 8.0: strongly irritating

Irritation parameter:

erythema score

Basis:

mean

Remarks:

# animals 1-3; intact and scarified skin

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

Irritation parameter:

edema score

Basis:

mean

Remarks:

#animals 1-3; intact and scarified skin

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:

No erythema or oedema formation was observed on any of the test animals at any observation time. Merely horny skin callus developed on the intact and scarified skin in the second observation period.

Other effects:

No systemic toxicity effects were observed after dermal application of the product.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, 1-pentene is not classified for skin irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a dermal irritation study performed similarly to the EU Method B4, 0.5 mL of test material was applied on intact and scarrified skin of 3 female Russian rabbits. Test sites were covered with an occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.

No reaction on intact or scarrified skin was found. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and oedema.

Based on the available data, the test item Pentene-1 was not skin irritant. No additional self-classification is proposed regarding skin irritation according to 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 skin irritation endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

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

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)

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

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

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

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

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

A key study was identified (ASTA-WERKE AG, 1982b, rel. 2). This dermal irritation study was performed similarly to the EU Method B4.

No evidence of skin irritation was observed in intact and abraded skins following a 4 -hour exposure period under an occlusive dressing.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and oedema.

Eye irritation:

A key study was identified (ASTA-WERKE AG, 1982c, rel.2). This eye irritation study was performed similarly to the EU Method B5.

No corneal or iridial effects were observed during the study.

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. for chemosis score.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Based on the available data, no additional self-classification is proposed for the registered substance regarding skin and eye irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No data was available regarding respiratory irritation. Not required for substances at the REACH Annex VII tonnage level.