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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When this study was performed, the LLNA did yet exist as an OECD guideline.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test substance (as cited in study report): Tinuvin 329
- Analytical purity: >99%
- Batch No.: EN 171744.92
- Physical state: solid
- Storage conditions: room temperature
- Validity: November 1993
Specific details on test material used for the study:
- Name of test substance (as cited in study report): Tinuvin 329
- Analytical purity: >99%
- Batch No.: EN 171744.92
- Physical state: solid
- Storage conditions: room temperature
- Validity: November 1993

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 Ltd., Animal Production, 4332 Stein, Switzerland
- Weight at study initiation (range): 351 g - 433 g
- Housing: individually in Makrolon cages (type 3)
- Diet: standard guinea pig pellets (NAFAG No. 845, Gosau SG); ad libitum
- Water: ad libitum
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: oleum arachidis (intradermal) and vaseline (epidermal)
Concentration / amount:
Induction, intradermal: 5% in oleum arachidis
Induction, epidermal: 30% in vaseline
Challenge, epidermal: 10% in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: oleum arachidis (intradermal) and vaseline (epidermal)
Concentration / amount:
Induction, intradermal: 5% in oleum arachidis
Induction, epidermal: 30% in vaseline
Challenge, epidermal: 10% in vaseline
No. of animals per dose:
- Test group: 10 males and 10 females
- Control group: 5 males and 5 females
Details on study design:
RANGE FINDING TESTS:
To identify irritant concentrations of the test substance a preliminary study was performed to select suitable, non-irritant concetration for the main study.
- Intradermal: 1% and 5% were tested and both were well tolerated
- Epidermal: 1, 5, 10 and 30% were tested and none of them induced erythema reactions

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: one intradermal application (3 pairs of intradermal injections (each 0.1 mL) were made simultaneously into the shaved neck of the guinea pigs)
- Test groups: intradermal: 1) adjuvant/saline mixture 1:1 (v/v), 2) test article in oleum arachidis (w/v), 3) test article in the adjuvant saline mixture (w/v);
- Control group: same treatment as test group only with adjuvant and vehicle
- Site: neck region
- Concentrations: intradermal: 5%

Epidermal:
- Test group: epidermal: closed patch exposure over the injection sites (test substance in vaseline, 2 x 4 cm², ca. 0.4 g paste per patch)
- Control groups: same treatment as test group only with adjuvant and vehicle
- Concentrations: 30% in vaseline
- Duration of exposure: 48 h
- Schedule: one week after intradermal induction (week 2)
week 3 and 4: no treatment

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day of challenge: day 29 (4 weeks after study initiation)
- Exposure period:24 h
- Test groups: the animals were tested with the test article in vaseline and the vehicle alone (patch 2 x 2 cm², 0.2 g paste per patch, occluded administration).
- Control group: The control group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Site: flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24 h and 48 h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.

OTHER:
The sesitivity of the strain is checked every six months with a known sensitiser, such as 2,4-dinitrochlorobenzene, para-phenylene-diamine or potasium-dichromate.
The body weight was recorded at start and end of the test.
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene, para-phenylene-diamine or potassium-dichromate.

Results and discussion

In vivo (non-LLNA)

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

Any other information on results incl. tables

Mean body weight (study initiation; study termination):

- Test group: males: 382 g; 602 g; females: 375 g; 564 g

- Control group: males: 383 g; 629 g; females: 377 g; 569 g

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met