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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:
disregarded due to major methodological deficiencies
Study period:
1979
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to a non-standard method, appplying 0.05 g of test material instead of 0.5 g. Documentation was insufficient for assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

Materials and methods

Principles of method if other than guideline:
A group of 6 miniature swine were dermally exposed to the test material, under a patch, for 48 h and then scored for irritation reactions.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Gamma-undecalactone
- Analytical purity: >95 %
- Storage condition of test material: Kept in light-intercepting ampoules at 5 °C
- Stability under test conditions: No detectable changes in compositions were observed during the experiment.

Test animals

Species:
other: miniature swine
Strain:
other: Pitman-Moore Improved strain
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.05 g
Duration of treatment / exposure:
Single treatment (48 h exposure)
Observation period:
48 h after application of test material
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- % coverage: 15 mm diameter patch
- Type of wrap if used: adhesive tape. The entire trunk of the animal was then wrapped with rubberized cloth for the 48 h period of exposure.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 48 hours

HISTOPATHOLOGY:
After scoring, all animals were killed and the dorsal skin was removed. Specimens of all animal skins were fixed in 10 % formalin solution. Celloidin-paraffin embedding was performed. 5 µ thick specimens were stained with hematoxylin-eosin for microscopic observation.

SCORING SYSTEM
Evaluation of skin reactions were performed as follows
1. On the living skin
Reddening rate (erythema)
- : no reddening
± : very slight reddening {barely perceptible}
+ : well defined reddening
++ : moderate reddening
+++: severe reddening (beet redness)
Others: scaling, crust formation, loss of elasticity and fissures
2. On the removed skin
dilating rate
swelling rate (edema)
bluing rate (increased capillary permeability)
bleeding rate
3. Total score
Total score (72 h reading) = dilating rate + swelling rate + bluing rate + reddening rate

Results and discussion

In vivo

Results
Irritation parameter:
other: total score
Basis:
mean
Remarks:
all animals
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None
Other effects:
No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test conditions, topical application of gamma-undecalactone did not induce skin irritation in miniature swine.
Executive summary:

In a primary dermal irritation study, a group of 6 miniature swine of the Pitman-Moore Improved strain was dermally exposed to gamma-undecalactone (0.05 g) on dorsal surface of each animal under a 15 mm diameter patch. The patches were secured in place by adhesive tape. The entire trunk of the animal was then wrapped with rubberized cloth for the 48 h period of exposure. After 48 h exposure the patches were removed and reactions were observed.

Gamma-Undecalactone did not induce skin irritation in miniature swine and the irritation score was 0.

Under the test conditions, topical application of gamma-undecalactone did not induce skin irritation in miniature swine. This study was conducted according to a non-standard method and documentation was insufficient for assessment.