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Registration Dossier
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EC number: 202-506-9 | CAS number: 96-45-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Mice were exposed by dermal route (epicutaneous, open) to ETU. After induction and challenge phase, the sensibilisant power of ETU was studied.
- GLP compliance:
- yes
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- An old study to evaluate the skin sensitisation was available before the REACH regulation ; no new study was performed.
Test material
- Reference substance name:
- Imidazolidine-2-thione
- EC Number:
- 202-506-9
- EC Name:
- Imidazolidine-2-thione
- Cas Number:
- 96-45-7
- Molecular formula:
- C3H6N2S
- IUPAC Name:
- imidazolidine-2-thione
- Details on test material:
- Other name = Ethylenethiourea (ETU)
ETU was obtained from the Aldrich Chemical Corporation Corp., Milwaukee, WI.
Lot #PC081687/B01 ; Purity > 99% (HPLC)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethylene glycol
- Concentration / amount:
- Induction : 1.0%, 3.0%, 10.0% ETU
Challenge : 10% ETU
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethylene glycol
- Concentration / amount:
- Induction : 1.0%, 3.0%, 10.0% ETU
Challenge : 10% ETU
- No. of animals per dose:
- 8 mice per group
- Details on study design:
- RANGE FINDING TESTS:
Primary irritancy studies indicated that all concentrations of ETU tested (up to 30%) were non-irritating.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 5 consecutive days
- Site: Dorsal surface site
- Frequency of applications: in continuously
- Concentrations: 1.0%, 3.0% or 10.0% ETU
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: no data
- Site: on the dorsal and ventral sites on the left ear.
- Concentrations: 10% ETU
- Evaluation (hr after challenge): 24 and 48hr
OTHER: Between Induction exposure and challenge exposure, there were 7 days.
Site preparation included intradermal injection of Freud's complete adjuvant in some mice.
The irritancy response was determined by monitoring the extravasation of 125 I- bovine serum albumin into the treated area. The contact hypersensitivity response was determined by monitoring the infiltration of 125 I-iododeoxyuridine laabeled cells into the challenge site in addition to the mouse ear swelling test. - Challenge controls:
- yes, vehicle control. see table.
- Positive control substance(s):
- yes
- Remarks:
- DNFB
Results and discussion
- Positive control results:
- The positive response with 0.5% DNFB was observed 24 hr after challenge.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 8
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
There were no treatment-related effects on survival or body weights. There was no evidence of skin irritation in the form of erythma or edema in any of the treatment groups. No statistically significant or dose-related hypersensitivity response was observed in mice sensitized with 1%, 3% or 10% ETU and challenge with 10% ETU.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under these experimental conditions, no statistically significant or dose-dependent contact hypersensitivity responses to ETU were observed in mice following dermal exposure.
- Executive summary:
ETU was tested in his sensibility with a mouse ear swelling test. The induction was made with 1.0%, 3.0%, 10.0% ETU, and the challenge with 10% ETU. There were no statistically significant or dose-dependent contact hypersensitivity responses with ETU.
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