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EC number: 204-385-8 | CAS number: 120-32-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Jan - 21 Feb 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- The challenge sites were evaluated 72 h after respective application in addition to the 24 and 48 h reading time points.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- adopted in 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 59 NohSan No. 4200
- Version / remarks:
- adopted in 1985
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted prior to the current requirement in Regulation (EC) 1907/2006 to perform a LLNA study (OECD 429) as the preferred in vivo skin sensitisation study.
Test material
- Reference substance name:
- Clorofene
- EC Number:
- 204-385-8
- EC Name:
- Clorofene
- Cas Number:
- 120-32-1
- Molecular formula:
- C13H11ClO
- IUPAC Name:
- clorofene
- Details on test material:
- Batch number: K0019
Constituent 1
- Specific details on test material used for the study:
- Appearance: white powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 5 - 7 weeks (males and females)
- Weight at study initiation: 362 - 466 g (males and females)
- Housing: individually in suspended, stainless-steel cages with carrot stick as enrichment
- Diet: certified guinea pig diet (#5026, Purina Mills, Inc.), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10% (w/v) (0.4 mL/site)
- Day(s)/duration:
- 6 h; one application per week for 3 weeks
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% (w/v) (0.4 mL/site)
- Day(s)/duration:
- 6 h
- Adequacy of challenge:
- other: in an irritation screening study a very faint erythema reaction (score of 0.5) was seen at one of the four sites treated with 5% test substance in propylene glycol
- No. of animals per dose:
- Irritation screening study: 2 per sex
Mean study: 5 per sex (control), 10 per sex (test groups) - Details on study design:
- RANGE FINDING TESTS: For the determination of the irritation threshold the test substance was administered epicutaneously to four animals at concentrations of 1, 5, 10 and 25% (w/v) in propylene glycol with each animal receiving all doses. After 6 h the patches and any residual test substance were removed. The observation of dermal reaction at 24, 48 and 72 h after test substance application showed no dermal irritation at 1%, a very faint erythema (score of 0.5) at one of the four sites at 5% and faint (score of 1.0 at two sites) to moderate (score of 2.0 with blanching at one site) at 10%. Moderate (score of 2.0 with blanching at one site) to strong (score of 3.0 with subcutaneous hemorrhaging and necrotic appearing areas at three sites) erythema reactions were observed at the highest concentration (25%). Based on the results of the screening test a concentration of 10% (w/v) was applied in the induction phase and 5% (w/v) was applied in the challenge phase of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: one week
- Test groups: 10% (w/v) test substance in dermal vehicle (propylene glycol)
- Control group: no treatment
- Site: along the dorsal anterior left quadrant
- Frequency of applications: one application per week
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: 24 h
- Test groups: 5% (w/v) test substance in dermal vehicle (propylene glycol)
- Control group: 5% (w/v) test substance in dermal vehicle (propylene glycol)
- Site: along the dorsal anteriar right quadrant
- Evaluation (hr after challenge): 24 h
OTHER:
- Clinical signs: The animals were observed for clinical signs daily throughout the study.
- Body weights: The body weights of the animals were recorded before the initial treatment and at termination. Animals of the irritation screening study were weighed only on the day of treatment. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde (epicutaneous induction: 2.5% (w/v) in ethanol, challenge: 1.0, 2.5 and 5.0% (w/v) in acetone)
Results and discussion
- Positive control results:
- Challenge with alpha-hexylcinnamaldehyde resulted in a positive response in test animals previously sensitised. Very faint to faint erythema reactions (scores of 0.5 - 1.0) were observed in 5/10 test animals at 1.0 and 2.5% (w/v) test substance in acetone. Very faint (score of 0.5 in 2/10 animals), faint (score of 1.0 in 3/10 animals) and moderate (score of 2.0 in 2/10 animals) erythema reactions were observed at 5.0% (w/v). In the control animals no erythema reactions were found following challenge with the test substance in acetone at 1.0 and 2.5%. Very faint erythema reaction was seen in 1/5 control animal at 5% at challenge.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 10%, challenge: 5% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction 10%, challenge 5% (w/v)
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%, challenge: 5% (w/v)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction 10% (w/v), challenge: 5% (w/v)
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Induction: 0%, challenge: 5% (w/v)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 10% (w/v), challenge: 5% (w/v)
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Individual Dermal Reactions – Challenge Phase
Animal number |
Test substance (5% (w/v) mixture) |
Vehicle |
||||
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
|
Test group |
||||||
1 |
0.5 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
2 |
0.5 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
3 |
1.0 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
4 |
0.0 |
0.5 |
0.5 |
0.0 |
0.0 |
0.0 |
5 |
1.0 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
6 |
0.5 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
7 |
0.0 |
0.0 |
0.5 |
0.0 |
0.0 |
0.0 |
8 |
0.5 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
9 |
2.0a |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
10 |
1.0 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
11 |
0.0 |
0.5 |
0.5 |
0.0 |
0.0 |
0.0 |
12 |
1.0 |
0.5 |
0.5 |
0.0 |
0.0 |
0.0 |
13 |
0.0 |
0.5 |
1.0 |
0.0 |
0.0 |
0.0 |
14 |
1.0 |
1.0 |
0.5 |
0.0 |
0.0 |
0.0 |
15 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
16 |
1.0 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
17 |
1.0 |
1.0 |
1.0d |
0.0 |
0.0 |
0.0 |
18 |
1.0 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
19 |
1.0 |
2.0 |
2.0f |
0.0 |
0.0 |
0.0 |
20 |
0.5 |
1.0 |
1.0 |
0.0 |
0.0 |
0.0 |
|
Control group |
|||||
1 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
2 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
3 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
4 |
0.0 |
0.5 |
1.0 |
0.0 |
0.0 |
0.0 |
5 |
0.0 |
0.5 |
0.5 |
0.0 |
0.0 |
0.0 |
6 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
7 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
8 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
9 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
10 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Score 0.0 = No reaction
Score 0.5 = Very faint erythema, usually nonconfluent
Score 1.0 = Faint erythema, usually confluent
Score 2.0 = Moderate erythema
a = Subcutaneous hemorrhaging
d = desquamation
f = fissuring
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- CLP: Skin sens. 1, H317
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