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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 December, 1979 - 06 February, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
no details on purity, no details on animal housing and environmental conditions
GLP compliance:
no

Test material

1
Chemical structure
Reference substance name:
Octahydro-2H-1-benzopyran-2-one
EC Number:
224-623-4
EC Name:
Octahydro-2H-1-benzopyran-2-one
Cas Number:
4430-31-3
Molecular formula:
C9H14O2
IUPAC Name:
octahydro-2H-1-benzopyran-2-one
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
- Animals in the telogen phase of hair growth were selected.

ENVIRONMENTAL CONDITIONS
No data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
8
Details on study design:
TEST SITE:
The whole dorsal surface was clipped 3-4 days before application of the test substance.

TREATMENT
Occlusive patches were prepared by attaching a piece of thin flexible polythene (3 cm x 3 cm) to a piece of zinc oxide plaster 9 cm x 2.5 cm. A 2.5 cm square of cotton gaue was laid on the polythene such that the edges of the patch were attached to the zinc oxide plaster. The undiluted test substance was applied to a dry patch. The patches were firmly attached to ensure good contact between the skin and test substance. The animals were immobilised in a canvas body sleeve for 4 hours after application of the patch.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the patches were removed and the skin are wiped clean of excess material.

OBSERVATIONS
- Mortality/Viability and Clinical signs: Daily
- Body Weight: At the start of acclimatization, day 1 (application day) and at termination (day 15)
- Irritation: The skin sites were assessed for irritation immediately after treatment, and at 24, 48 and 72 hours. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
12
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
12
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal:
Remarks:
#3 and #8
Time point:
24/48/72 h
Score:
1
Max. score:
12
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal:
Remarks:
#4 and #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
12
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
12
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal:
Remarks:
#7
Time point:
24/48/72 h
Score:
1
Max. score:
12
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
12
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
12
Irritation parameter:
edema score
Basis:
animal: #3 and #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
12
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
12
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
12
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
0.67
Max. score:
12
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
1
Max. score:
12
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
Reaction grades erythema 72 hours after treatment: three animals marginal/very slight and five animals no effects observed. Reaction grades oedema 72 hours after treatment: three animals marginal/very slight and five animals no effects observed. Six animals showed also marginal/very slight cracking and two animals showed marginal/ very slight scaling, 2 animals showed no cracking/scaling. No results on the reversibility as the observation period was not extended to 7 days.
Other effects:
- No mortality occurred

Any other information on results incl. tables

Skin irritation response data (for the undiluted test substance)

 Observation time     24 hours     48 hours     72 hours
 Animal no.:  erythema  oedema  erythema  oedema  erythema  oedema
 1  -  1  -  -  -  1
 2  1  -  -  -  -  -
 3  1  1  1  -  1  -
 4  2  2  -  -  -  -
 5  3  2  1  1  1  1
 6  2  1  -  -  -  -
 7  2  1  1  1  -  -
 8  1  1  1  1  1  1

1 = marginal/very slight

2 = slight

3 = fairly distinct

4 = quite distinct

6 = becoming well developed

8 = well developed

10= becoming severe

12= severe

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments
Conclusions:
In a skin irritation study with rabbits, performed equivalent to OECD 404 guideline, limited irritation was observed. As the substance showed marginal /very slight irritating to skin 72 hours after treatment and the symptoms were less than 24 and 48 after treatment, the substance does not have to be classified for skin irritation.
Executive summary:

The substance was tested in 8 rabbits in a skin irritation test equivalent to OECD TG 404 test guideline.Reaction grades of erythema 72 hours after treatment showed three animals with marginal/very slight whereas five animals showed no effects. Reaction grades of oedema 72 hours after treatment showed three animals with marginal/very slight and five animals showed no effects. No results on the reversibility as the observation period was not extended to 7 days. As the substance showed marginal /very slight irritating to skin 72 hours after treatment and the symptoms were less than 24 and 48 after treatment, the substance does not have to be classified for skin irritation.