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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 16, 1999 to May 04, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD guideline
Qualifier:
according to guideline
Guideline:
other: Directive 96/54/EC, B.6 maximisation test
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
other: Albino guinea pig, Charles River
Sex:
male
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal: 0.1 ml

1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline

2) test substance diluted to 5 % (w/w) in PEG 400

3) test substance diluted to 5 % (w/w) by emulsion in a

1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline


epidermal:

test substance 25 % in PEG 400

Concentration of test material and vehicle used for each challenge:
epidermal:

test substance 0.5 % in PEG 400
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
intradermal: 0.1 ml

1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline

2) test substance diluted to 5 % (w/w) in PEG 400

3) test substance diluted to 5 % (w/w) by emulsion in a

1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline


epidermal:

test substance 25 % in PEG 400

Concentration of test material and vehicle used for each challenge:
epidermal:

test substance 0.5 % in PEG 400
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
.5 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
Possible erythema reaction could not be determined due to
substance-related red staining of the skin. However, no
oedema was observed.

Evidence of sensitisation of each challenge concentration:
Concentration 0.5%: 0/10 (0%) animals showed sensitization.

Other observations:
MORTALITY/CLINICAL SIGNS:

No mortality and no clinical signs were noted in this study.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not sensitising
Executive summary:

None of the animals of the control and test group were observed with skin reactions after challenge tretament with the test item at 0.5% in PEG 400.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
None of the animals of the control and test group were observed with skin reactions after challenge tretament with the test item at 0.5% in PEG 400. The substance is not considered to be a skin sensitizer.

Justification for selection of skin sensitisation endpoint:
only existing study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not need to be classified as none of the animals of the control and test group were observed with skin reactions after challenge tretament with the test item at 0.5% in PEG 400 in a Maximization test.

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