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Diss Factsheets

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:
16 February 1994 - 31 March 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one
EC Number:
247-074-2
EC Name:
(Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one
Cas Number:
25524-95-2
Molecular formula:
C10H16O2
IUPAC Name:
(Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one
Test material form:
liquid
Details on test material:
Identification: JASMINLACTONE
Chemical name: (Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one
CAS number: 25524-95-2
Appearance/Physical state: Clear, colorless liquid
Lot: 8500119
Purity: 99.63%
Expiry date: 26 November 2021
Storage conditions: Approximately 4 °C, in the dark, under Nitrogen
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot No.of test material: 19004
- Purity: 94.5 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cold and dark place.

Test animals

Species:
rabbit
Strain:
other: SPF Japanese white rabbits
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 11 weeks old
- Weight at study initiation: from 2.2 to 2.3 kg
- Housing: each of the animals was housed in a suspended aluminum cage with a wire net at the bottom of it (32W x 48D x 33H cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25
- Humidity (%): 40 to 70
- Air changes (per hr): 12 times
- Photoperiod (hrs light): 12 hours a day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the patches were removed.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: the dorsal area of the trunk of animals
- Type of wrap if used: a semipermeable soft bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours of exposure, the test substance was wiped off with absorbent cotton saturated with mildly wam water.

OBSERVATION TIME POINTS : 1, 24, 48 and 72 hours after the patches were removed

SCORING SYSTEM:
- Method of calculation: The degrees of formation of erythema and crusts (hereinafter referred to as erythema) and edema were evaluated in accordance with the criteria stipulated in the OECD Guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
- Skin reaction: No irritation was observed in any animal up to 72 hours after the patches were removed.
- General state of health: No change was observed in any cases until the observation was completed.
- Body weight: No effect of the test substance was observed in any cases (Table 1).

Any other information on results incl. tables

Table 1: Individual body weights

 Animal No  Before application  72 hours after the removal of patch
 1  2.3 2.4 
 2  2.2 2.2 
 3  2.3 2.4 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test item did not cause irritation on the skin of rabbits under the conditions of this test.
Executive summary:

A study was performed to determine the skin irritation potential of the test item. The study was performed according to OECD test guideline 404 and in compliance with GLP.

A single semi-occlusive dose of 0.5 ml of test item was applied to the skin of three SPF Japanese white female rabbits for 4 hours. Animals were observed for 72 hours.

No irritation was observed up to 72 hours after the patches were removed, hence the test item is considered not to be irritating to skin.