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Registration Dossier
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EC number: 616-995-5 | CAS number: 8018-01-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-02-11 to 1998-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24th February 1987
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sarabhai Research Centre, Wadi Wadi, Baroda - 390 007
- Age at study initiation: 5 months old at the time of test substance instillation
- Weight at study initiation: 1.56 to 1.91 kg
- Housing: Individual in stainless steel wire meshed cage (45 cm breadth x 60 cm length x 45 cm height)
- Diet: Rat 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 18 and 21
- Humidity (%): 64
- Air changes (per hr): 20 - 25
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Half a minute after instillation the treated eyes of the three rabbits were washed with distilled water for half a minute using a volume and velocity of flow which did not cause injury.
- Observation period (in vivo):
- Readings of ocular lesions were made at 1 hour, 24 hours, 48 hours and 72 hours after the treatment.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: washing with water
- Time after start of exposure: 0.5 minute
SCORING SYSTEM: in accordance with scoring system according to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test item is slightly irritant to the rabbit eye, but classification according to CLP Regulation is not required.
- Executive summary:
This study was performed to assess the acute eye irritation potential of the test item in rabbits. The methods followed were as per the Organization for Economic Co-operation and Development (OECD) for testing of chemicals no. 405 (adopted 24th February, 1987) "Acute Eye Irritation"
Three healthy, adult male albino rabbits of New Zealand white strain, were selected for the study. An amount of 100 mg of the test item was instilled into an eye of each rabbit and the contralateral eye served as the control. Half a minute after instillation eye of all rabbits were washed with distilled water for half a minute using a volume and velocity of flow which did not cause injury. Observations were made following the method provided by the guidelines of the Organization for Economic Cooperation and Development (OECD) for testing of chemicals no. 405 (adopted 24th February 1987) "Acute Eye Irritation", at 1 hour (day 0), 24, 48 and 72 hours after instillation. The ocular reactions consisted of redness and chemosis. Redness was observed in all animals 1 hour after treatment and in 2 out of 3 animals at 24 and 48 hours. Chemosis was only noticed in 2 out of 3 animals at 1 and 24 hours. At 72 hours after treatment, all treated eyes were normal. In addition, no clinical toxic signs other than ocular were observed. Under the conditions of this study the test item is slightly irritant to the rabbit eye, but classification according to CLP Regulation is not required.
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