Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-02-24 to 1992-05-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD 406, adopted 1981), GLP compliant. Acceptable deviation from OECD Guideline 406 (adopted 1992): skin reactions after induction treatment were not reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland;
- Weight: 355 to 448 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Temperature: 22 +/- 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day
- Diet and water: The animals received ad libitum standard guinea pig pellets and fresh water.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal application: 5 % of test item in 20 % propylene glycol and 80 % physiological saline;
Epidermal induction: 30 % test item in vaseline;
Epidermal challenge: 10 % test item in vaseline;
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Intradermal application: 5 % of test item in 20 % propylene glycol and 80 % physiological saline;
Epidermal induction: 30 % test item in vaseline;
Epidermal challenge: 10 % test item in vaseline;
No. of animals per dose:
10 males /10 females in the test group,
5 males / 5 females in the control group;
Details on study design:
A. INDUCTION EXPOSURE
First induction, intradermal injection:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article (5 %) in 20 % propylene glycol + 80 % physiological saline (w/v)
- test article (5 %) in the adjuvant saline mixture (w/v)

Second induction (one week later week), epidermal application:
The test item (30 %) in vaseline (w/w) was applied on a filterpaper patch to the neck of the animals (0.4 g paste per patch; occluded administration for 48 hours).
The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).

Control group animals were treated identically in the absence of test item.

B. CHALLENGE EXPOSURE
Test and control group animals were treated (week 5) on the flank with the test item (10 %) in vaseline (w/w) and the vehicle alone (approx. 0.2 g paste per patch; occluded administration for 24 hours).
Skin reactions were scored 24 and 48 hrs after patch removal.
Positive control substance(s):
yes
Remarks:
Potassium dichromate

Results and discussion

Positive control results:
The positive control (tested at 0.2 % and 5 % during intradermal and topical induction, and 1 % during challenge) induced skin sensitising reactions in 70 % of the animals, indicating the sensitivity of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information