Registration Dossier
Registration Dossier
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EC number: 202-506-9 | CAS number: 96-45-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001/02/26 - 2001/05/08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
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
- Reference substance name:
- ethylenethiourea
- IUPAC Name:
- ethylenethiourea
- Details on test material:
- - Name of test material (as cited in study report): ETU
- Characteristics: light beige powder
- Assay (purity) = 99.6%
- Lot/batch No.: L33-99
- Storage condition of test material: at room temperature or colder
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and toxicology kg
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: singly in special restrainers with dimensions of 425 mm x 6000 mm x 380 mm which allowed free movement of the head but prevented a complete body turn.
- Diet (e.g. ad libitum): altromin 2023, available before and after the exposure period.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 55+/-15%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg ETU per patch per animal, once epicutaneous
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24-48-72 hours
- Number of animals:
- 3 rabbits (males)
- Details on study design:
- TEST SITE
- Area of exposure: dermal application to the shaved intact dorsal skin
- % coverage: 6 cm²
- Type of wrap if used: a gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Any reaction was observed: erythema score and edema score were equal to 0 at all time.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
- Conclusions:
- Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
ETU was non-irritating to skin, hence, no labelling is required. - Executive summary:
The aim of this examination was to examine ETU for acute skin irritation in rabbits (patch test). After the 4 -hour exposure period, the patch was removed and the skin sites of the three animals were evaluated.
Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg ETU per patch and animal showed any substance-related lesions at the examination time-points 60 min, and 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
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