Registration Dossier
Registration Dossier
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EC number: 601-147-9 | CAS number: 111988-49-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Apr - 09 May 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- other: Report amendment
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2015
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported, effect on body weight / general condition not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(2-chlor-5-pyridyl-methyl)-cyanimino-1,3-thiazolidin
- EC Number:
- 601-147-9
- Cas Number:
- 111988-49-9
- Molecular formula:
- C10H9ClN4S
- IUPAC Name:
- 3-(2-chlor-5-pyridyl-methyl)-cyanimino-1,3-thiazolidin
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: not specified; adult animals
- Weight at study initiation: 3.5 - 4.6 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases
- Diet: 100 - 120 g per animal/day standard diet "Ssniff K4" (Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: about 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 50 - 70
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 25 Apr 1995 To: 09 May 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg test substance moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed "Hypoallergen" dressing (Beiersdorf No. 2342 PV3) fastened with semiocclusive elastic adhesive tape (Fixomull Stretch Klebevlies, Beiersdorf No. 2293)
REMOVAL OF TEST SUBSTANCE
- Washing: exposed skin area was cleaned with water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- E16
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- B12
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- E17
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight erythema (grade 1) were noted for all three animals 1 h after exposure. This effect was unchanged at later time points and full reversibility observed within 48 h (1/3 animals) or 72 h (2/3 animals). No effect on edema was observed in all three animals.
- Other effects:
- No further effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The study is in accordance with OECD TG 404, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance did not induce skin irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.
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