Registration Dossier
Registration Dossier
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EC number: 605-268-8 | CAS number: 161797-99-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17/05/2011-17/06/2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate
- EC Number:
- 605-268-8
- Cas Number:
- 161797-99-5
- Molecular formula:
- C13H14ClNO3S
- IUPAC Name:
- ethyl 2-(4-hydroxyphenyl)-4-methyl-1,3-thiazole-5-carboxylate
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 17 weeks
- Weight at study initiation: 3.36 and 3.66 kg
- Housing: in an animal room
- Diet (e.g. ad libitum): a commercial pellet diet, RC4 was fet ad libitum
- Water (e.g. ad libitum): tap water via an automatic watering system ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): 8 x/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- An amount of 0.5 g of the test substance moistened with the smallest amount of distilled water was spread on a cotton lint patch and this patch was affixed to the dorsal skin of rabbit.
- Duration of treatment / exposure:
- An initial test that consisted of the exposures to the test substance for 3 minutes, 1 hour and 4 hours was executed using one animal, and then a confirmatory test consisting of 4-hour exposure to the test substance was executed using 2 animals.
- Observation period:
- Skin reactions were observed immediately after and at 1 hour after the patch removal at a test site exposed for 3 minutes, and were observed at 1, 24, 48 and 72 hours after the patch removal at test sites exposed for 1 and 4 hours.
- Number of animals:
- 3 female rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A potential skin irritation/corrosion of Manufacturing Intermediate of TMX-67 (Thiazole Derivative (Free Base Form)) to rabbit skin was not classified into any of
categories based on the criteria of GHS under the conditions of this study.
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