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EC number: 276-012-7 | CAS number: 71786-55-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 16th to May 16, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo non-LLNA study was already available, therefore data was used for assessment
Test material
- Reference substance name:
- Reference Substance 02
- IUPAC Name:
- Reference Substance 02
- Test material form:
- solid
- Remarks:
- blue powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd, Basel
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: 346-445 grams
- Housing: Group housing of 2 animals per labelled metal cage with wire-mesh floors.
- Diet: Free acces to standard guinea pig diet (pellet diameter 4mm), including ascorbic acid (1600 mg/kg). Hay once a week
- Water: Free access to tap-water, diluted with decalcified water.
- Acclimation period: At least five days before start of treatment under test conditions after physical examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% (w/w)
- Day(s)/duration:
- day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50% (w/w)
- Day(s)/duration:
- Day 8 / 24 hour
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 25% 10% 5%
- Day(s)/duration:
- Day 22 / 24 hour
- No. of animals per dose:
- 20 test group
10 control group
5 primary irritation experiment - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Site: area of the dorsal skin from the scapular region, clipped free of hair
- Duration: 48 hours
- Concentrations: 50% (w/w) in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Site: left flank
- Concentrations: 25%, 10%, 5% in vaseline
- Evaluation (hr after challenge): 24 and 48 hours after challenge
OTHER: - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% (w/w)
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- red spots and/or scaliness
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- red spots and/or scaliness
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% (w/w)
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- red spots and/or scaliness
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0 % in distilled water
- No. with + reactions:
- 0
- Remarks on result:
- other: n. of hours after challenge and number of animals in the group not indicated
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.1 % in distilled water
- No. with + reactions:
- 8
- Remarks on result:
- other: n. of hours after challenge and number of animals in the group not indicated
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.25 % in distilled water
- No. with + reactions:
- 12
- Remarks on result:
- other: n. of hours after challenge and number of animals in the group not indicated
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.5 % in distilled water
- No. with + reactions:
- 20
- Remarks on result:
- other: n. of hours after challenge and number of animals in the group not indicated
Any other information on results incl. tables
Animal number |
Induction day 10 |
Induction day 10 |
Challenge day 24 |
Challenge day 24 |
Challenge day 24 |
Challenge day 24 |
Challenge day 25 |
Challenge day 25 |
Challenge day 25 |
Challenge day 25 |
Comments |
Experimental group |
|||||||||||
36 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
sensitized |
37 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
sensitized |
38 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
not sensitized |
39 |
0 |
0 |
1s |
1 |
0 |
0 |
1s |
1 |
1 |
0 |
sensitized |
40 |
1 |
0 |
0 |
0 |
1s |
0 |
0 |
1 |
1s |
0 |
sensitized |
41 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
not sensitized |
42 |
0 |
0 |
0 |
0 |
0 |
0 |
0s |
1 |
1 |
0 |
sensitized |
43 |
1 |
0 |
1b |
0 |
1b |
0 |
1bs |
1 |
1bs |
0 |
sensitized |
44 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
sensitized |
45 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
sensitized |
46 |
1 |
0 |
1b |
0b |
0 |
0 |
1bs |
1bs |
0 |
0 |
not sensitized |
47 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
not sensitized |
48 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
sensitized |
49 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
sensitized |
50 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
sensitized |
51 |
1 |
0 |
1b |
0 |
0 |
0 |
1bs |
1 |
1 |
0 |
sensitized |
52 |
0 |
0 |
1bs |
1bs |
1bs |
0 |
1bs |
1s |
1s |
0 |
sensitized |
53 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
not sensitized |
54 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
not sensitized |
55 |
1 |
0 |
0 |
1bs |
0 |
0 |
0 |
1s |
0 |
0 |
not sensitized |
Control group |
|||||||||||
56 |
0 |
0 |
0b |
0 |
0 |
0 |
0b |
0 |
0 |
0 |
|
57 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
58 |
0 |
0 |
1bs |
0 |
0 |
0 |
0s |
0 |
0 |
0 |
|
59 |
0 |
0 |
0 |
0b |
0 |
0 |
0 |
0bs |
0 |
0 |
|
60 |
0 |
0 |
0b |
0 |
0 |
0 |
0b |
0 |
0 |
0 |
|
61 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
62 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
63 |
0 |
0 |
1bs |
0b |
0 |
0 |
1s |
1s |
0 |
0 |
|
64 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
65 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
ER = Erythema
OE = Oedema
a = Concentrations (%) in vaseline
b = Particles of test substance were noted pressed into the skin
s = Scaliness
Applicant's summary and conclusion
- Interpretation of results:
- other: According to CLP (CE) n. 1272/2008 criteria the test substance is classified in category 1b
- Conclusions:
- Under the conditions used in this study, test substance resulted in a sensitisation rate of 65 per cent.
According to CLP (CE) n. 1272/2008 criteria the test substance is classified in category 1b. - Executive summary:
The purpose of the study was to obtain information on the potential of the test substance to induce delayed contact hypersensitivity (skin sensitisation) in the guinea pig after intradermal and epidermal exposure.
After identification of the slightly irritating and the non-irritating test substance concentrations in the primary irritation experiments, a main study was performed with selected test substance concentrations. The experimental animals were intradermally injected with a 5% concentration in physiological saline and epidermally exposed with a 50% concentration in vaseline, while the control animal were similarly treated, but with the vehicles only.
Immediately after the epidermal exposure, the skin irritation was scored. Two weeks after the epidermal application all animals were challenged with test substance concentrations of 25%, 10%, 5% and the vehicle. The challenge reactions were assessed 24 and 48 hours after bandage removal.
The epidermal exposure of test substance in the induction phase resulted in slight erythema in fifteen of the twenty animals. The epidermal exposure of test substance in the challenge phase resulted in thirteen positive sensitisation reactions in response to the 5% test substance concentrations.
No simptoms of systemic toxicity were observed in the animals duringn the study. No mortality occurred during the study.
Under the conditions used in this study, test substance resulted in a sensitisation rate of 65 per cent.
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