Registration Dossier
Registration Dossier
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EC number: 616-995-5 | CAS number: 8018-01-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-11-04 to 1997-11-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17th July 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Complexation products of manganese and zinc with ethylenebis(dithiocarbamate)
- EC Number:
- 616-995-5
- Cas Number:
- 8018-01-7
- Molecular formula:
- (x+y)[C4H6N2S4]2- + xMn2+ + yZn2+, x:y ranges between 1:0.062 to 1:0.12 (mean 1:0.091)
- IUPAC Name:
- Complexation products of manganese and zinc with ethylenebis(dithiocarbamate)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sarabhai Research Centre, Wadi Wadi, Baroda-390 007
- Weight at study initiation: 1.62 to 2.25 kg
- Housing: Individual in stainless steel wire meshed cage
- Diet: Rabbit pellet feed (Amrut brand) ad libitum (MF: Nav Maharashtra Chakan Oil Mills Limited, 43, Shaniwar Peth, Pune-411 030, Maharashtra, India)
- Water: Pure drinking water filtered through Aquaguard water filter system ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 22 ± 1.1 and 24 ± 1.8
- Humidity (%): 79 ± 8.9
- Air changes (per hr): 13 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin changes such as erythema and edema were scored at 0, 1, 24, 48 and 72 hours after the removal of the test item.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: gauze patch secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed with wet cotton
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
0, 1, 24, 48 and 72 hours after the removal of the test item.
SCORING SYSTEM:
- Method of calculation: Draize scoring
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:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1 - #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined not to be irritating to the skin.
- Executive summary:
This study was performed to assess the acute dermal irritation potential of the test item to the rabbit. The method followed was as per the Organisation for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals No. 404 (adopted 17th July 1992) "Acute Dermal Irritation".
A single dose of 500 mg test item was moistened with distilled water and applied to intact skin of three male rabbits and kept in place for 4 hours, after which the test substance was removed with wet cotton. Observations were recorded at 1, 24, 48 and 72 h after removal of patch, using the Draize method to score dermal irritation. The treated skin sites in all animals appeared normal at one hour after patch removal.
The primary irritation index (PII) observed was 0 at 1, 24, 48 and 72 hour observation. Thus, the test item is classified as non-irritant to rabbit skin.
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