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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Primary skin irritation study in rabbits
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 18 1992 to December 8 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
A study conducted under Good Laboratory Practice Standards (40 CFR) and conforming with internationally recognized protocols and in particular satisfying criteria of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and OECD Guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: The protocol satisfies the criteria established by the Federal Insecticide, Fungicide, and Ro denticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
Deviations:
no
Principles of method if other than guideline:
Young adult, male and female New Zealand White rabbits were used. The test material was administered as received.
GLP compliance:
yes (incl. QA statement)
Remarks:
All aspects of this study, as defined in the Protocol and the Project Instruction Sheet, were conducted in accordance with Good Laboratory Practice Standards (40 CFR).

Test material

Constituent 1
Chemical structure
Reference substance name:
3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
EC Number:
242-149-6
EC Name:
3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
Cas Number:
18268-70-7
Molecular formula:
C24H46O7
IUPAC Name:
3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
Specific details on test material used for the study:
The test material was a clear, golden-yellow liquid and was stored at room temperature throughout the study in two clear, glass jars.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Young adult male and female New Zealand White rabbits were used. The animals were purchased from a U.S.D.A. approved supplier.

All animals were acclimated to the laboratory for one day before use. Animals were housed singly in wire mesh suspension cages and were supplied PURINA LABORATORY RABBIT CHOW (or other comparable diet) and tap water ad libitum except for the withholding of food overnight prior to dosing. The animals were maintained in 12-hour light/12-hour dark cycles.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female
Details on study design:
On the day prior to the dosing the application sites were prepared by clipping the hair from the dorsal surface of each animal.

A 0.5 gram aliquot of the undiluted test material was applied to to each animal under a one inch X one inch gauze patch, two layers thick. Each patch was held in place with adhesive tape. After application of the patch, the trunk of each animal was wrapped with rubber dental dam and this secured with staples. An outer layer of gauze was wrapped around the trunk of each animal and secured with tape. Each animal was fitted with an appropriate restraining device to prevent wrapping and patch removal. Following approximately 4 hours of exposure, the wrapping and patches were removed. The test sites were wiped free of residual test material by gentle sponging using a moistened towel.

The application sites were scored for each rabbit according to Draize at approximately 1/2 to 1 hour, 24 hours, 48 hours and 72 hours. Any other notable responses were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
2.8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site and minor desquamation at 168 hr
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site and minor desquamation at 168 hr
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site and minor desquamation at 168 hr
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
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:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Hair on site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Minor desquamation at site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Minor desquamation at site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
Minor desquamation at site at 168 hr
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
1
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:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
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:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
1
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

Skin Irritation Test Ref.: 92-8820-21 C
Intact Skin
Rabbit No. Erythema Score Oedema Score Comments
/Observation Time
       
No. 1      
1 hour 2 2 Hair on site
24 hour 2 2 Hair on site
48 hour 2 2 Hair on site
72 hour 1 0 Hair on site
168 hour 0 0 Hair on site - Desq.
Mean 24,48, 72 1.67 1.33  
No. 2      
1 hour 1 1  
24 hour 2 1  
48 hour 1 1  
72 hour 1 0  
168 hour 0 0  
Mean 24,48, 72 1.33 0.67  
No. 3      
1 hour 2 2 Hair on site
24 hour 2 2 Hair on site
48 hour 2 1 Hair on site
72 hour 1 0 Hair on site
168 hour 0 0 Hair on site
Mean 24,48, 72 1.67 1.00  
No. 4      
1 hour 2 2  
24 hour 2 1  
48 hour 2 1  
72 hour 2 1 Desq. At site
168 hour 0 0 Desq. At site
Mean 24,48, 72 2.00 1.00  
No. 5      
1 hour 1 1  
24 hour 2 2  
48 hour 2 1  
72 hour 0 0  
168 hour 0 0  
Mean 24,48, 72 1.33 1.00  
No. 6      
1 hour 2 1  
24 hour 2 1  
48 hour 1 0  
72 hour 0 0  
168 hour 0 0  
Mean 24,48, 72 1.00 0.33  

For each rabbit, erythema and eschar formation scores were recorded at 1/2 to 1 hours, 24 hours, 48 hours and 72 hours and these values totaled for each rabbit. The eight averaged scores from this were added together and the sum divided by 4 to obtain a Primary Irritation Index (PII).

Applicant's summary and conclusion

Interpretation of results:
other: Category III accordiing to 40 CFR 156.10
Remarks:
Moderate irritation at 72 hours.
Conclusions:
The primary skin irritancy of undiluted test material was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

Moderate irritation persisted 72 hours following applications. All animals were held for 7 days at which time all irriatation had cleared.

The Primary Irritation Index (PII) was found to be 2.8 based on erythema and edema.

The only change noted in the coloration and/or texture of the skin was desquamation that persisted in 2 of the 6 test animals.

No evidence of corrosion was found.

Based on mean 24, 48 and 72 hour scores for erythema/eschar or for oedema, TegMeR(R) 804 would not be classified as a skin irritant under the EU CLP Regulation.