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EC number: 428-650-4 | CAS number: 153719-23-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: 59 NohSan No. 4200
- Version / remarks:
- 1985
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine
- Cas Number:
- 153719-23-4
- Molecular formula:
- C8H10ClN5O3S
- IUPAC Name:
- 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white female rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:15 weeks old
- Weight at study initiation: 2.50 to 2.71 kg
- Housing: animals were housed individually in aluminium cages with wire mesh bottoms
- Diet: RC4 pellet diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 50 ± 20
- Air changes: at 8 to 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Start: 20 Oct. 1995; End: 31 May 1996
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 lint (6.3 cm2)
- % coverage: not specified
- Type of wrap if used: The application site was covered with oil-paper followed by the semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed after the exposure period and the skin was wiped with absorbent cotton soaked in ‘water for injection’ to clean the application site so that any reactions (erythema) were clearly visible at that time
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours and 7 and 10 days after patch removal
SCORING SYSTEM:
Method of calculation: the skin was scored according to the OECD scoring system (see Table 1 in 'any other information on materials and methods incl. tables'). Mean values of scores from 24-48-72 hours per animal were taken for the classification. The interpretation of the results is based on table 2 in 'any other information on materials and methods incl. tables'.
CLINICAL SIGNS
Clinical signs were observed periodically for 6 hours after application and then once daily thereafter at the same time as dermal observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- With a single application of the test substance to the rabbit skin, no irritant dermal reactions were observed and the primary dermal irritation index was zero.
- Other effects:
- No abnormalities in the clinical signs any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With a single application of the test substance to the rabbit skin, no irritant dermal reactions were observed.
- Executive summary:
In a primary dermal irritation study, six 13 week old Japanese white female rabbits were dermally exposed to 0.5 g of the test substance (98.6%) for 4 hours to the previously clipped skin of the rabbits dorsal area. Animals then were observed for up to 72 hours after removal of the test material. Irritation was scored by a table for evaluation of dermal reactions. Based on the results and under the conditions of this study, it was concluded that the test substance has no irritant effect on the rabbit skin according to the Draize classification criteria.
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