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EC number: 695-022-6 | CAS number: 473278-76-1
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Feb - 25 Mar 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Test Guidelines for Agricultural Chemicals (Notification No. 12-Nousan-8147)
- Version / remarks:
- amended 10 Dec 2002
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted prior to the current requirement in Regulation (EC) 1907/2006 to perfrom an LLNA study (OECD 429) as the preferred in vivo skin sensitisation study.
Test material
- Reference substance name:
- 2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione
- Cas Number:
- 473278-76-1
- Molecular formula:
- C20 H23 Cl O7 S
- IUPAC Name:
- 2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 369.6 ± 6.6 g (controls), 379 ± 4.8 g (test group)
- Housing: two or five animals in a cage of standard size on dust-free white wood shavings
- Diet: FD1 MOD (P) SQC SDS/DIETEX (SDS Special Diets Services, Witham, UK), ad libitum
- Water: drinking water enriched with 0.02% vitamin C, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 45 - 65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% (w/v) in water
- Concentration / amount:
- 1%
- Day(s)/duration:
- single injection
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (0.5 g test substance moistened with 0.5 mL 1% carboxymethylcellulose)
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (0.5 g test substance moistened with 0.5 mL 1% carboxymethylcellulose)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range-finding study:
4
Main study:
5 (controls), 10 (test group) - Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed to determine the appropriate dose level of the test substance following intradermal and epicutaneous administrations. According to the results of a previous study, the maximum concentration for proposing homogeneous injectable dosing formulation of the test substance was 1% (w/v) in 1% (w/v) carboxymethylcellulose (CMC). For the selection of the topical application test substance concentrations of 25% (w/v) in 1% (w/v) carboxymethylcellulose and 100% (0.5 g test substance moistened with 0.5 mL of 1% (w/v) CMC ) were investigated. No skin lesions were observed up to and including 100% test substance concentration following topical application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Injection 1: a 1:1 mixture FCA/isotonic sodium chloride solution
Injection 2: 1% (w/v) test substance in 1% (w/v) CMC
Injection 3: equal amounts of 1% (w/v) test substance and FCA in isotonic sodium chloride solution
Epicutaneous: undiluted test substance (skin pre-treated with 10% SDS in vaseline)
- Control group:
Injection 1: a 1:1 mixture FCA/water
Injection 2: 1% (w/v) CMC
Injection 3: equal amounts of 1% (w/v) CMC and FCA in isotonic sodium chloride solution
Epicutaneous: 1% (w/v) CMC
- Site: retro-scapular region of the vertebral column
- Frequency of applications: on Day 1 and 9
- Duration: Days 1-9
- Concentrations: intradermal 1%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 23
- Exposure period: 24 h
- Test groups: undiluted test substance
- Control group: undiluted test substance
- Site: right lateral abdominal region
- Concentrations: 100% (0.5 g test substance moistened with 0.5 mL 1% carboxymethylcellulose)
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene, Induction: intradermal and epicutaneous 1% in alcoholic solution, Challenge: 1% in alcoholic solution
Results and discussion
- Positive control results:
- The positive control substance induced positive reactions (scores 2 and 3) in 5/5 animals (100%).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction:1%; challenge: 100%
- 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:
- positive control
- Dose level:
- Induction:1%; challenge: 1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1%; challenge: 100%
- 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:
- positive control
- Dose level:
- Induction:1%; challenge: 1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Behaviour of animals treated with test substance was normal and not different from that of the control group.
Mean body weight gain of animals treated with test substance was comparable to the weight gain of the control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.
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