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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:
July 19, 1995 to October 13, 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Version / remarks:
July 1, 1991
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
EC Number:
271-517-9
EC Name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
Cas Number:
68583-52-8
Molecular formula:
C10-H20-O2.C8-H16-O2.C6-H14-O4
IUPAC Name:
Decanoic acid, mixed diesters with octanoic acid and triethylene glycol
Specific details on test material used for the study:
The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Six (3M:3F) New Zealand white rabbits, weighing approximately two (2) kilograms and about three (3) months of age, were obtained from Davidson Mill Breeding Laboratories in Jamesburg, New Jersey. Animals were checked carefully upon receipt for diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition.

Animals were acclimated for six (6) days prior to test initiation. They were individually housed in stainless steel cages, in a room with 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare Regulations with an approximate range of 65° to 75° F. The humidity was also monitored. Diet consisted of Lab Diet Cerified Rabbit Diet #5322, as well as water, ad libitum. Animals were identified through individual markings on the outer ear of each animal, as well ac a cage label.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days maximum
Number of animals:
6
Details on study design:
Twenty-four (24) hours prior to test initiation, the animals were reexamined. Any animals in poor condition, and particularly animals with skin eruptions or dermal lesions, were not used. Animals were prepared for testing by close clipping the hair of the mid-dorsal area of the trunk, between the scapulae and the pelvis, using an Oster® small animal clipper equipped with a #40 (surgical) head. Care was taken to avoid abrasion of the skin during clipping.

Immediately prior to test initiation, the animals were placed in wooden restrainers. One (1) test site, approximately six (6) centimeters square, was chosen on each animal. Each site remained intact. A single application of one-half (0.5) of a milliliter of the test article was made to each test site. The test article was then covered with a five (5) cm2 surgical gauze pad (Johnson & Johnson gauze sponge). The latter was held in place with three (3) inch Johnson & Johnson Dermicel® hypo-allergenic cloth tape, semi-occlusively.

The wrapping and test article were removed four (4) hours following application. Remaining test article was gently washed from the skin with water and paper towels. Each test site was individually examined and scored 30 to 60 minutes after unwrapping for erythema and edema using the Draize skin scoring scale (refer to the table). The presence of effects not listed in the scoring Kai.: was also noted. Observations continued until all irritation subsides or irritation present was confirmed to be irreversible (14 days maximum).

The daily scores were averaged and evaluated in conjunction with the nature and reversibility of the response observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Average Draize scores
Basis:
mean
Time point:
14 d
Score:
2.3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
14 d
Score:
1.15
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
Minimal irritation persisting to 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks:
minimal irritation persisting until 14 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Intact Skin
Rabbit No. Erythema Score Oedema Score Comments
/Observation Time
       
No. 1      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 2 1  
7 days 2 0  
14 days  1  0  
Mean 24,48, 72 1.33 0.33  
No. 2      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 1 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 1.00 0.00  
No. 3      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 2 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 0.67 0.00  
No. 4      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 2 0  
7 days 0 0  
14 days 0 0  
Mean 24,48, 72 0.67 0.00  
No. 5      
4 hour 0 0  
24 hour 1 0  
48 hour 1 0  
72 hour 1 1  
7 days 2 1  
14 days 1 0  
Mean 24,48, 72 1.00 0.33  
No. 6      
4 hour 0 0  
24 hour 0 0  
48 hour 0 0  
72 hour 1 0  
7 days 1 0  
14 days 0 0  
Mean 24,48, 72 0.33 0.00  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According 40 CFR 798.4470 (July 1, 1991) and under the conditions of this test, this test article elicited minimal to mild irritation. Two (2) sites exhibited minimal erythema at 14 days. All other sites exhibited no signs of irritation at 14 days.