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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973
Principles of method if other than guideline:
The method empoyed in the testing, evaluation and the scoring of the results was similar to that described in Section 1500.41 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973.
In carrying out the study the experimental sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals´ backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleedings. The skin of the other side was allowed to remain intact. A 0.5 gr. portion of material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then placed over the treated areas vand an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.
The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize Method of Scoring was employed.
GLP compliance:
no
Remarks:
done before GLP was established

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
EC Number:
269-348-0
EC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Cas Number:
68227-33-8
Molecular formula:
C16H30O2
IUPAC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Constituent 2
Reference substance name:
2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
IUPAC Name:
2,5,8,11-tetramethyl-6-dodecyne-5,8-diol
Test material form:
other: waxy solid white

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
other: gauze patches
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
5.17
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
not specified

Any other information on results incl. tables

Erythema and Eschar Formation        Reading                  Rabbit Number       Average

(Hours)                   1 2 3 4 5 6 

Intact skin                                             24                        3 2 2 2 3 2              2.33

Intact skin                                             72                        3 2 2 2 3 3              2.50

Abraded skin                                        24                        3 2 2 2 3 2            2.33

Abraded skin                                        72                        4 3 3 3 3 3             3.17

Subtotal: 10.33

      

Edema Formation                              Reading                  Rabbit Number       Average

(Hours)                   1 2 3 4 5 6 

Intact skin                                              24                      3 2 3 2 3 3  2.67

Intact skin                                              72                      3 2 2 2 3 3 2.50

Abraded skin                                         24                      3 2 3 2 2 2         2.33

Abraded skin                                          72                     3 2 3 3 3 3 2.83

Subtotal: 10.33

Total:        20.66

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the accompanying table, the subject material would be classified as a primary irritant to albino rabbits within the definition of the act-reference: Section 1500.3 (c) (4) and requires cautionary labeling with respect to that section.