cis-hex-3-en-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 August to 9 August 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: U.S. Federal Register Test (1964)

Deviations:

no

Principles of method if other than guideline:

The rabbit was securely restrained by a technician. The left side of the shaved dorsum was abraded by drawing the tip of a lancet across the skin forming a lattice pattern with parallel abrasions at intervals of 5- 10 mm. The abrasions were such as the break the stratum corneum of the epidermis without damaging the underlying tissues or causing bleeding. The right of the shaved site was left intact.

GLP compliance:

no

Remarks:

Study predates GLP.

Test material

Test material information

Constituent 1

Reference substance name:

cis-hex-3-en-1-ol

EC Number:

213-192-8

EC Name:

cis-hex-3-en-1-ol

Cas Number:

928-96-1

Molecular formula:

C6H12O

IUPAC Name:

hex-3-en-1-ol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): cis-3-hexen-1-ol
- Physical state: colourless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, England
- Age at study initiation: 2.5- 3 months
- Weight at study initiation: 2.2- 3.3 kg
- Housing: animals were individually housed in suspended galvanised and stainless steel cages in batteries manufactured by Cope & Cope Limited. The cages measured 0.6 x 0.6 x 0.4 m high and were fitted with mesh floors and automatic watering. A sledge running the length if the battery removed waste matter from an undertray beneath the cage floors, as required.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 °C ± 2 °C
- Humidity (%): 50 % ± 10 %
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 14/ 10

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of test material was impregnated onto unmedicated gauze patches (25 x 25 mm) and were applied, 1 patch to each side of the abraded and intact treatment areas.

Duration of treatment / exposure:

23 h

Observation period:

24 h, 72 h and 7 d

Number of animals:

6

Details on study design:

TEST SITE
- Type of wrap if used: patches were covered by slightly larger sheets of aluminium foil, and were kept in place by an impermeable bandage of a plastic self-adhesive dressing which was wrapped twice around the trunk of the rabbit with sufficient tension to ensure the test material was in close contact to the skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test material was removed by gently washing with warm water ans drying the site with paper towels.
- Time after start of exposure: 23 h

SCORING SYSTEM: reactions of the intact and abraded test sites were assessed according to the criteria of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 1

Time point:

other: 24 h, 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 24 h, 72 h

Score:

0.5

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 24 h, 72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 4

Time point:

other: 24 h, 72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 5

Time point:

other: 24 h, 72 h

Score:

0

Results 6

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 6

Time point:

other: 24 h, 72 h

Score:

0.5

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 24 h, 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 24 h, 72 h

Score:

0.5

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 24 h, 72 h

Score:

0.5

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 4

Time point:

other: 24 h, 72 h

Score:

0

Results 11

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 5

Time point:

other: 24 h, 72 h

Score:

0

Results 12

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 6

Time point:

other: 24 h, 72 h

Score:

0.5

Irritant / corrosive response data:

Upon single dermal application of the test material, barely perceptible and/or well-defined erythematous responses were provoked on intact and/or abraded skin in 3 animals at 24 h. Four animals displayed slight oedematous responses on intact and/or abraded skin at the 24-h reading. The responses diminished in intensity so that, by 72 h, 2 animals displayed barely perceptible erythematous responses and 1 very slight oedematous response. One animal displayed discolouration of the abraded skin at 24 and 72 h. All animals displayed loss of pliability of intact and abraded skin. On Day 8 one animal displayed severe erythema with loss of flexibility and discolouration of intact and abraded skin; 1 animal displayed moderate to severe erythema to severe erythema and exfoliation on intact and abraded skin and 2 animals displayed exfoliation on intact and abraded skin.

Any other information on results incl. tables

Scoring of irritance responses elicited by single dermal application of 0.5 mL of test material under a 24 -h occlusive bandage

Animal number & sex	Type of response	Score at 24 hours		Score at 72 hours		Overall score	Score at Day 7
		Intact skin	Abraded skin	Intact skin	Abraded skin		Intact skin	Abraded skin
3TA 155 ♂	Erythema	0	2^+	0*	0*	1.00	4^+α	4^+α
	Oedema	0	2	0	0		0	0
3TA 157 ♂	Erythema	0	0	1*	1*	1.00	0*	0*
	Oedema	1	1	0	0		0	0
3TA 158 ♂	Erythema	0	2	0*	1*	1.50	0	0*
	Oedema	0	1	1	1		0	0
3TA 159 ♂	Erythema	0	0	0*	0*	0	0^ε	0^ε
	Oedema	0	0	0	0		0	0
3TA 160 ♂	Erythema	0	0	0*	0*	0.25	0^ε	0^ε
	Oedema	0	1	0	0		0	0
3TA 161 ♂	Erythema	1	1	0^+*	0^+*	1.00	3^ε	3^ε
	Oedema	1	1	0	0		0	0

⁺- Discolouration

*- Loss of pliability

ε- Exfoliation

α- Loss of flexibiility

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The test material was assessed for irritance responses during a single application of the test material on the intact and abraded skin of the dorsum of rabbits. The test substance is not considered to be irritating to skin according to the classification criteria of CLP Regulation (EC) no. 1272/2008

Executive summary:

The test material was assessed for irritance responses during a single application of the test material on the intact and abraded skin of the dorsum of rabbits. 0.5 mL of test material was impregnated onto unmedicated gauze patches and were applied, 1 patch to each side of the abraded and intact treatment areas. Upon single dermal application of the test material, barely perceptible and/or well-defined erythematous responses were provoked on intact and/or abraded skin in 3 animals at 24 h. Four animals displayed slight oedematous responses on intact and/or abraded skin at the 24-h reading. The responses diminished in intensity so that, by 72 h, 2 animals displayed barely perceptible erythematous responses and 1 very slight oedematous response. One animal displayed discolouration of the abraded skin at 24 and 72 h. All animals displayed loss of pliability of intact and abraded skin. On Day 8 one animal displayed severe erythema with loss of flexibility and discolouration of intact and abraded skin; 1 animal displayed moderate to severe erythema to severe erythema and exfoliation on intact and abraded skin and 2 animals displayed exfoliation on intact and abraded skin. Under the conditions of this study the test substance is not considered to be irritating to skin.