Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: valid with restrictions; meets generally accepted scientific standards, well documented and 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:
1981
Bibliographic source:
Umweltbundesamt (UBA-FB 82-019) Forschungsbericht 107 04 006/01

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Thioharnstoff

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
Reading:
other: 3rd
Hours after challenge:
72
Group:
test group
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: other: 3rd. . Hours after challenge: 72.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
other: 3rd
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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.