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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(adopted in 1981)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Carried out according to the maximization test of Magnusson and Kligman (J. Invest. Dermatol. 52, 268-276, 1969).
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When this test was performed, the LLNA did not yet exist.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Source: no data
- Batch No.: EN 24705
- Purity: techn. qual.
- Appearance: white powder
- Validity: 12/1984
- Stability under the condition of administration: not determined
Specific details on test material used for the study:
- Batch No.: EN 24705
- Purity: techn. qual.
- Appearance: white powder
- Validity: 12/1984
- Stability under the condition of administration: not determined

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba Geigy AG
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 328 - 468 g
- Housing: individually in macrolon cages (type 3)
- Diet: ad libitum; guinea pig pellets (NAFAG No. 846, Gossau SG), feed was supplemented with fresh carrots
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14/10

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Sesame oil (intradermal induction), vaseline (epicutaneous induction and challenge)
Concentration / amount:
Intradermal induction: 1 %
Epicutaneous induction: 30 %
Challenge: 30 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Sesame oil (intradermal induction), vaseline (epicutaneous induction and challenge)
Concentration / amount:
Intradermal induction: 1 %
Epicutaneous induction: 30 %
Challenge: 30 %
No. of animals per dose:
20 (10 males + 10 females)
Details on study design:
PRELIMINARY TEST: The concentrations of the test compound for the induction and challenge period were determined on separate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
A1. Intradermal Injection
- Site of injection: neck
- Number of injections: 2/ formulation
- Formulations: 1). mixture of adjuvant and saline, 2). test compound in sesame oil (test group) or sesame oil (control group), 3). test compound in the adjuvant saline mixture (test group) or adjuvant saline mixture without test compound (control)
- Volume per injection: 0.1 mL/ formulation
- Evaluation (hr after injection): no data

A2. Epicutaneous induction exposure:
- Time schedule: one week after intradermal inductions
- Site: same as intradermal injections (site was pretreated the day before with 10% sodium lauryl sulphate: open application)
- Concentrations: 30 % (test group), and vehicle (control group)
- Volume applied: no data
- Type of coverage: occlusive
- Duration: 48 hours
- Evaluation (hr after challenge): no data

B. CHALLENGE EXPOSURE (identical treatment for treated and control animals)
- Time schedule: two weeks after topical induction
- Site: flank (one flank: test substance) other flank (vehicle)
- Vehicle: vaseline
- Concentrations: 30 %
- Volume applied: no data
- Type of coverage: occlusive
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure.
- Evaluation method: Draize scoring
Positive control substance(s):
yes
Remarks:
The sensitivity of the strain is controlled every six months with p - phenylenediamine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 % in vehicle
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: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 % in vehicle
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: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30 % in vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30 % in vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Body weights were taken before the start of the treatment and at termination.

Control animals

- At start: Mean (n = 20) = 380.7 +/- 36.66 g

- At termination: Mean (n = 20) = 528.4 +/- 68.74 g

Test group animals

- At start: Mean (n = 20) = 383.3 +/- 31.65 g

- At termination: Mean (n = 20) = 532.1 +/- 54.17 g

Applicant's summary and conclusion

Interpretation of results:
not sensitising