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Diss Factsheets

Administrative data

Description of key information

Slightly irritating to skin and severe ocular irritant and possibly corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
other: albino
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
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

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

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
according to guideline
Guideline:
other: Act-Reference: Section 1500.42 (b) (1) (2) P. 27019
GLP compliance:
no
Remarks:
done before establishment of GLP
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 gr
Duration of treatment / exposure:
see method description
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 1
Score:
38.5
Max. score:
41
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day2
Score:
47
Max. score:
57
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 3
Score:
40.2
Max. score:
53
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 5
Score:
23.3
Max. score:
29
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 7
Score:
23.3
Max. score:
25
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the accompanied data, the subject material is a primary occular irritant within the definition of the act reference: Section 1500.42 (b) (1) 82) P. 27019 and requires cautionary labeling with respect to that section.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.2 and Chapter 3.3 it is classified to be irritating to eye.