Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2 April - 10 May 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline, non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Bio-terge PAS-8S

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Age at study initiation:no data
- Weight at study initiation: 225-325 g
- Housing: singly in wire mesh suspensioncages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr): 12 h/12 h
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
No. of animals per dose:
10 male/10 female
Details on study design:
RANGE FINDING TESTS:
Test substance applied at 100 %, 50 %, 25 %, 10 %, 5 %, 2.5 % or 1 % w/v in distilled water. 4 concentrations/ guinea pig. 0.3 mL/patch. Occluded conditions. Based on the results, a concentration of 25 %w/v was chosen for induction and 5 %w/v for primary challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.3 mL of 25 %w/v solution
- Control group: none
- Site: upper left quadrant of backs
- Frequency of applications: weekly
- Duration: 6 hours under occlusive conditions
- Concentrations: 25 %w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:2 weeks after last induction
- Exposure period: 6 hours
- Test groups: 0.3 mL of 5 %w/v solution
- Control group: 0.3 mL of 5 %w/v solution
- Site: lower left quadrant of backs
- Concentrations: 5 %w/v solution
- Evaluation (hr after challenge): 24 & 48 h

OTHER:
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean severity of skin scores = 0.0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean severity of skin scores = 0.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 %wv/v
No. with + reactions:
1
Total no. in group:
19
Clinical observations:
Mean severity of skin scores = 0.03
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %wv/v. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: Mean severity of skin scores = 0.03.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %w/v
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
Mean severity of skin scores= 0.2
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %w/v. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Mean severity of skin scores= 0.2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 %w/v
No. with + reactions:
5
Total no. in group:
19
Clinical observations:
Mean severity of skin scores = 0.1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %w/v. No with. + reactions: 5.0. Total no. in groups: 19.0. Clinical observations: Mean severity of skin scores = 0.1.

Any other information on results incl. tables

One animal in the test group was found dead after the third induction. Necrospy showed lungs pale, liver pale, abdominal cavity filled witha red blood-like material and slight post mortem autolysis.

The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group, indicating that sensitisation had not been induced.

Applicant's summary and conclusion

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