Registration Dossier
Registration Dossier
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EC number: 245-740-7 | CAS number: 23564-05-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 May 1986 - 01 June 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the OECD guidline 429 (LLNA) entered into force.
Test material
- Reference substance name:
- Thiophanate-methyl
- EC Number:
- 245-740-7
- EC Name:
- Thiophanate-methyl
- Cas Number:
- 23564-05-8
- Molecular formula:
- C12H14N4O4S2
- IUPAC Name:
- methyl N-{[2-({[(methoxycarbonyl)amino]methanethioyl}amino)phenyl]carbamothioyl}carbamate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Laboratory Animal Center (Shizuoka, Japan)
- Age at study initiation: 6 weeks old
- Weight at study initiation: 337 - 440 g, Mean : 387.1 g, SD : 20.9 g
- Housing: Steel mesh cage (26 x 38 x 20 cm), 2 animals/cage
- Diet: RC-4 (Oriental Yeast Co., Ltd. (Tokyo, Japan))
- Water: tap water, ad libitum
- Acclimation period: 1 week (quarantine)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (mean)
- Humidity (%): 68 (mean)
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 3.5 % (w/v)
- 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: white vaseline
- Concentration / amount:
- 42 % (w/w)
- Day(s)/duration:
- 7 days after intra dermal injection / 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white vaseline
- Concentration / amount:
- 42 % (w/w)
- Day(s)/duration:
- 2 weeks after epicutaneous application / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal injections: three pairs of injections [1) Freund's Complete Adjuvant emulsion, 2) test item without adjuvant, 3) Mixture of Freund's Complete Adjuvant and test item); Epicutaneous application: one application]
- Exposure period: Epicutaneous application: 48 hours
- Test group: 20 animals, treated with test substance
- Control group: 20 animals, treated with 2,4-dinitrochlorobenzene
- Site: dorsal side
- Frequency of applications: Intradermal injections: one application, Epicutaneous application: one application
- Duration: Epicutaneous application: 48 hours
- Concentrations: Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 2 weeks after epicutaneous application
- Exposure period: 24 hours
- Test group: 20 animals, treated with test substance
- Control group: 20 animals, treated with 2,4-dinitrochlorobenzene
- Site: right flank
- Concentrations: 42 % (w/w)
- Evaluation (hr after challenge): 24, 48 and 72 - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- Positive skin reactions were observed in all guinea pigs treated with the positive control.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Key result
- Reading:
- other: 3nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Intradermal injections: 3.5 % (w/v), Epicutaneous application: 42 % (w/w)
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- other: 3nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Intradermal injections: 0.1 % (w/v), Epicutaneous application: 1 % (w/w)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item was determined to be a skin sensitiser.
- Executive summary:
A Magnusson's "Maximization test" was performed in female guinea pigs to determine the skin sensitising potential of the test item. The test was performed with 40 animals, 20 animals were treated with the test item and 20 animals were treated with the positive control substance 2,4-dinitrochlorobenzene. For intradermal induction three pairs of intradermal injection were made [1) Freund's Complete Adjuvant emulsion, 2) test item without adjuvant, 3) Mixture of Freund's Complete Adjuvant and test item]. Six day after the injections the entire area of the sites was clipped and 10% sodium lauryl sulfate was massaged into the clipped area without bandaging. After 24 hours, the test and control compounds were spread over a patch of filter paper (2 cm x 4 cm) in a thick even layer and applied to the corresponding areas of the skin of the guinea pigs for 48 hours.The challenge application was performed on the shaved area of the flank after 2 weeks of the topical application. The test agents were applied on 2 x 2 cm patches of filter papers which were contacted for 24 hours under a sealed dressing. The challenge sites were evaluated at 24, 48 and 72 hours after the removal of the patches by a 4-point scale. Positive reactions were observed in guinea pigs treated with the positive control or the test item. Therefore, the test item was determined to be a skin sensitiser.
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