Registration Dossier

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)
Rationale for reliability incl. deficiencies:
other: study full in compliance with OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A guideline-compliant GPMT was available from a period before the LLNA-guideline was adopted. The GPMT was considered sufficient to demonstrate the absence of a sensitizing potential of the test substance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Desmophen VPPU 1907
- Physical state: liquid
- Analytical purity: content 99.9 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor : DHPW
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
5% for intradermal induction
100% for topical induction
50% and 100% for first challenge
25% for second challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
5% for intradermal induction
100% for topical induction
50% and 100% for first challenge
25% for second challenge
No. of animals per dose:
control: 10 animals/group
test substance: 20 animals/group
Details on study design:
RANGE FINDING TESTS:
- for intradermal induction: concentrations of 0, 1, 2.5, and 5 % were tested
- for topical induction: concentrations of 0, 12, 25, 50 % and 100 % were tested
- for challenge: concentrations of 0, 12, 25, 50 and 100 % were tested


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2; first induction intradermal, second induction topical 7 days later
- Exposure period: 48 h oclcusive in the topical induction
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5 % for intradermal induction, 100 % for topical induction
- Because the substance was not a skin irritant in the pilot study, the test area after shaving was painted with a solution of 10% sodium lauryl sulphate before topical induction

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: challenge started 3 weeks after intradermal induction
- Exposure period: 24 hours
- Concentrations: 50 % and 100 %
- Evaluation (hr after challenge): 48 and 72 hours after start of challenge

Reliability of the test system is routinely confirmed by alpha hexyl cinnamic aldehyde among others.
Challenge controls:
yes: control group animals were treated in challenge experiments according to test group animals
Positive control substance(s):
yes
Remarks:
Reliability of the test system is routinely confirmed by alpha hexyl cinnamic aldehyde among others.

Results and discussion

Positive control results:
Routinely performed tests with positive controls confirmed the reliability of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
erythema: score 1
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema: score 1.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
erythema: score 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema: score 1.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Executive summary:

Under the conditions of guinea pig maximization test according to OECD TG 406 the substance was shown to exhibit no skin sensitization potential.