Registration Dossier
Registration Dossier
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EC number: 407-430-1 | CAS number: 3741-80-8 CP22595; SANTOCURE TBS1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to US EPA and EEC methods. Minor deviations from animal housing and care AAALAC standards were reported, but were considered to have had no effect on the oucome of this study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
- EC Number:
- 407-430-1
- EC Name:
- N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
- Cas Number:
- 3741-80-8
- Molecular formula:
- C18H17N3S4
- IUPAC Name:
- bis(1,3-benzothiazol-2-ylsulfanyl)(tert-butyl)amine
- Details on test material:
- - Name of test material (as cited in study report): CP-22595
- Physical state: off white powder
- Analytical purity: 89.0 - 93.3%
- Purity test date: 21 December 1989 and 06 April 1990.
- Lot/batch No.: 4064285
- Stability under test conditions: confirmed by HPLC experiment
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Trabbitry, Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually housed in suspended stainless steel cages in an environment-controlled room
- Diet (e.g. ad libitum): Prolab Rabbit Ration, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
- Animal identification: plastic ear tags
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70°F (= ca. 16-21°C)
- Humidity (%): 40-60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: distilled - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6: 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch
- % coverage: not specified
- Type of wrap if used: gauze patch + tubular stockinette sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- EPA dermal evaluation scoring : the 30-60 minutes, 24, 48 and 72 hour erythema and edema scores were added and the total divided by 24 to yield the mean Primary Irritation Index (P.I.I.).
- EEC dermal evalution: the 24, 48 and 72 hour erythema and edema scores were added separately and each total divided by 18 to yield a primary irritation inex for both erythema and edema.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- EPA Primary Irritation Index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: nonirritant
- Irritation parameter:
- erythema score
- Remarks:
- EEC Primary Irritation Index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: nonirritant
- Irritation parameter:
- edema score
- Remarks:
- EEC Primary Irritation Index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: nonirritant
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Exposure to the test substance produced no signs of dermal irritation throughout the study.
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