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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-02-14 and 1994-04-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-conform, according to OECD guideline 406 and Method B6 92/69/EEC
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 312 to 417 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets -NAFAG No. 845, ad libitum
- Water: ad libitum


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

Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
No. of animals per dose:
control group: 10
test group: 20
Details on study design:
MAIN STUDY
A.1. INDUCTION EXPOSURE (intradermal); on day: 0
- Exposure period: three pairs of indermal injections (0.1 mL per injection) were made simultaneously
- Test groups: adjuvant/ saline mixture 1:1 (v/v), 5% test substance in physiol. saline (w/v), 5% test substance in the adjuvant/saline mixture (w/v)
- Control group: injection: adjuvant/ saline mixture 1:1 (v/v), adjuvant/saline mixture 1:1 (v/v), physiol. saline
- Site: injection: left and right side of the shaved neck
- Duration: single injection

A.2. INDUCTION EXPOSURE (epidermal); on day: 8
- Test group: 50% test substance in physiol. saline
- Control group: physiol. saline only
- Site: neck of the animal
- Duration: 48 hours

B. CHALLENGE EXPOSURE; on day 21
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups and Control group: one flank: 30% test substance in physiol. saline; other flank: physiol. saline alone
- Site: flank
- Evaluation (hr after challenge): 24 and 48

Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole
Positive control results:
All of the animals showed skin reactions after 24 h and 48 h after removing the dressings.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group (vehicle control)
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group (test article control)
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group (vehicle control)
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group (test article control)
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: test group (vehicle group)
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (vehicle group). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: test group (test article)
Dose level:
30%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
1 animal showed erythema and edema, 4 animals showed only erythema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed erythema and edema, 4 animals showed only erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: test group (vehicle control)
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (vehicle control). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: test group (test article)
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a dermal sensitization study, the test substance (80% act. ingr.) was tested in male and female Pirbright guinea pigs by using the Guinea Pig Maximisation Test of Magnusson and Kligman (induction treatment: 5% given intradermal on day 0, 50% given epidermal on day 8; epidermal challenge treatment: 30% on day 21). Body weights were not affected by treatment. Under the experimental conditions employed, 25% of the animals of the test group showed skin reactions (erythema and/or edema) 24 hours after removing dressing. On the basis of the results the test material (80% act. intgr.) is considered to be not skin-sensitising.


Migrated from Short description of key information:
According to the Guinea Pig Maximisation Test of Magnusson and Kligman the test substance (80% act. integr.) is not skin-sensitising.

Justification for selection of skin sensitisation endpoint:
only reliable study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.