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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:
31 August 1995- 07 February 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC Guidelines, Annex V Methods (Directive 92/69/EEC of 31 July 1992)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexenyl acetate cis and trans
- Substance type: no data
- Physical state: yellow liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 248859
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stored in the dark under ambient conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Limited, Shaw's Farm, Blackthorn, Bicester, OX6 0TP
- Age at study initiation: yound adult
- Weight at study initiation: 3.36- 3.56 kg
- Housing: the rabbits were housed individually in aluminium cages (48 x 61 x 46 cm) with grid floors beneath which were absorbent paper lined trays. Floors, cage racks, walls and ceilings were cleaned with disinfectant solution (0.5 % Tego 2000, Th Goldschmidt and Company Limited) as necessary.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 61
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 28 September 1995 To: 12 October 1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h continuing up to 14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage:
- Type of wrap if used: The patch of gauze was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin wiped with water
- Time after start of exposure: 4 h

SCORING SYSTEM
Erythema and Eschar Formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (area raised by more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal 1
Time point:
other: 24 h, 48 h, 72 h
Score:
1
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal 2
Time point:
other: 24 h, 48 h, 72 h
Score:
1.3
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal 3
Time point:
other: 24 h, 48 h, 72 h
Score:
1
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal 1
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal 2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal 3
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Irritant / corrosive response data:
All animals showed slight erythema from 1- 72 h after patch removal. In 1 animal an increase to more definite erythema was noted at 24 h after patch removal. This animal continued to show slight erythema for 14 d after patch removal, with the skin becoming dry and flaky at the test site after 13 d.

No oedema was noted during the observation period.

Any other information on results incl. tables

Hexenyl acetate cis and trans acute dermal irritation test in rabbits reaction scores

Rabbit

Erythema

1 h

24 h

48 h

72 h

4 d

7 d

10 d

11 d

13 d

14 d

301

1

1

1

1

0

0

0

0

-

-

302

1

2

1

1

1

1

1

1

1*

1*

303

1

1

1

1

0

0

0

0

-

-

 

Rabbit

Oedema

1 h

24 h

48 h

72 h

4 d

7 d

10 d

11 d

13 d

14 d

301

0

0

0

0

0

0

0

0

-

-

302

0

0

0

0

0

0

0

0

0

0

303

0

0

0

0

0

0

0

0

-

-

Animals were shaved at 11 days after patch removal

h = hours after patch removal

d = days after patch removal

* = skin dry and flaky at test site

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was assessed for acute dermal irritation according to OECD guideline 404. The test substance is classifed as not irritating although it was found to be a mild irritant to rabbit skin under the conditions of this test.