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Diss Factsheets

Administrative data

Description of key information

Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10

Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
according to OECD Guideline 406 (Skin Sensitisation)
Species:
guinea pig
Strain:
other: Hartely albino
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Vehicle:
other: Acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)

Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Vehicle:
other: Acetone
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)

Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 6
Details on study design:
not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Positive control results:
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
1
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
1
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 6.0.
Group:
positive control
Remarks on result:
other: Not available

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation of each challenge concentration:

100 % test material moistened with acetone 0/10

Other observations:

At challenge, 4 previously untreated animals were doesd with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group.

Interpretation of results:
other: Not classified
Conclusions:
From the above information, it was concluded that the test chemical was not sensitizing to the skin of guinea pigs.
Executive summary:

Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10

Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Respiratory sensitisation

Endpoint conclusion
Additional information:

Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10

Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.

Justification for classification or non-classification

The test chemical is not sensitizing in nature.