Registration Dossier
Registration Dossier
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EC number: 200-543-5 | CAS number: 62-56-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Überprüfung der Durchführbarkeit von Prüfungsvorschriften und der Aussagekraft der Grundprüfung des E.Chem.G. - Sensibilisierungstest
- Author:
- Korte, F.; Greim, H.
- Year:
- 1 981
- Bibliographic source:
- Umweltbundesamt (UBA-FB 82-019) Forschungsbericht 107 04 006/01
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no information on use of 10% SDS
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before LLNA was made mandatory
Test material
- Reference substance name:
- Thiourea
- EC Number:
- 200-543-5
- EC Name:
- Thiourea
- Cas Number:
- 62-56-6
- Molecular formula:
- CH4N2S
- IUPAC Name:
- thiourea
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: pirbright white
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co, D-4923 Exertal 1
- Age at study initiation: 21-28 Tage
- Weight at study initiation: 250-300 g
- Housing: two animals in one cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/-1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 0.5-10% induction; 20 % challenge
Challengeopen allclose all
- Route:
- other: percutaneous
- Vehicle:
- no data
- Concentration / amount:
- 0.5-10% induction; 20 % challenge
- No. of animals per dose:
- 20 male animals were tested altogether; in the positive control additional 20 animals were tested
- Details on study design:
- RANGE FINDING TESTS: yes; 2-3 animals; estimation of the probable sentising effects; determination of dose to induce after intradermal treatment an irritation; percutaneous treat did not lead to irritation
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: 0.5-10% substance; 0.5%-10% substance + mixture containing of Freund`s adjuvant Complete and vehicle (1:1)
- Control group: Freund`s adjuvant Complete and vehicle (1:1)
- Site:at the back
- Frequency of applications: once
- Duration: 24 h
- Concentrations: 0.5-10%
Reading after 1 h and 24 h
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 7 days after first exposure
- Exposure period: 48 h (occlusive)
- Test groups: 2 ml 20% solution of test substance
- Control group: not reported
- Site: at the back between front and rear extremities
- Concentrations: 20 % solution
- Evaluation (hr after challenge): 72 h
OTHER: positive control: 20 animals treated with Penicllin G-Na - Positive control substance(s):
- yes
- Remarks:
- Penicllin G-Na
Results and discussion
- Positive control results:
- valid; 100% sensibilization
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 5000 IE/ 0.1ml
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: other: 3rd. Hours after challenge: 72.0. Group: positive control. Dose level: 5000 IE/ 0.1ml. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: not reported.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no adverse effect
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study thiourea is not sensitising.
- Executive summary:
In a dermal sensitization study with Thiourea (0.5-10%) male guinea pigs (pirbright white) were tested using the method of Magnusson and Kligman. Induction was performed intradermal. Penicillin G-Na was used as positive control.
In this study Thiourea is not a dermal sensitizer.
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