Registration Dossier
Registration Dossier
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EC number: 283-381-8 | CAS number: 84604-96-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25th Sept 2012 - 28th Sept 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 april 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- EC Number:
- 283-381-8
- EC Name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- Cas Number:
- 84604-96-6
- Molecular formula:
- C38H76N2S4Zn
- IUPAC Name:
- bis({[bis(3,5,5-trimethylhexyl)carbamothioyl]sulfanyl})zinc
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch no 165021121120039.2
Manufactured by registrant
Expiry: 10 Jul 2013
Storage conditions: room temperature in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan labs uk ltd
two New Zealand Rabbits
- Age at study initiation: 12- 20 weeks old
- Weight at study initiation: 2.49 or 2.52kg
- Housing:indiviually housed in suspended cages
- Diet (e.g. ad libitum): free access to mains drinking water and 2930c Teklad global certified rabbit diet
- Water (e.g. ad libitum):
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): minimum 15 changes per hour
- Photoperiod (hrs dark / hrs light): time switch 12 hours light and 12 hours darkness
Day 3 - final body weights were 2.66 and 2.64 kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- 0.5g of test item moistened sufficiently with 0.5ml of distilled water, introduced under a cotton patch
- Controls:
- no
- Amount / concentration applied:
- 0.5g test item
Initially the pH of test item as 10% w/w aqueous preparation was determined as pH 9.2 then measured after 10 mins and confirmed as pH 9.3 - Duration of treatment / exposure:
- four hour application
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 2 males
- Details on study design:
- no deviations
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Erythema
- Value:
- 0
- Vehicle controls validity:
- not valid
- Negative controls validity:
- not valid
- Positive controls validity:
- not valid
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Individual scores for erythema/eschar and oedema were 0 for both animals. The primary irritation index for both animals exposed to the test item was zero (0.0) and classifed as non irritant to rabbit skin according to the Draize classification scheme ( "Dermal Toxicity " Draize JH 1959)
No evidence of skin irritation was noted during the study at any time point. Animals showed expected gain in body weight during the study. - Executive summary:
A single four hour, semi -occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation
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