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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
412-440-4
EC Name:
-
Cas Number:
2725-22-6
Molecular formula:
C33-H39-N3-O2
IUPAC Name:
2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartely albino
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
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)
Challenge
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

Results and discussion

Positive control results:
not specified

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.