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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal 1
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24 h, 72 h
Score:
0.5
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 4
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 5
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 h, 72 h
Score:
0.5
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24 h, 72 h
Score:
0.5
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24 h, 72 h
Score:
0.5
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 4
Time point:
other: 24 h, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 5
Time point:
other: 24 h, 72 h
Score:
0
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

4

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

0ε

0ε

Oedema

0

0

0

0

0

0

3TA 160 ♂

Erythema

0

0

0*

0*

0.25

0ε

0ε

Oedema

0

1

0

0

0

0

3TA 161 ♂

Erythema

1

1

0+*

0+*

1.00

3ε

3ε

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.